Synthèse de la recherche sur les thérapies, traitements des lésions de la moelle épinière en 2019

Mise à jour: mai 2019.

ATTENTION, CET ARTICLE EST UNE ARCHIVE ! 

POUR LES TOUTES DERNIERES MISES A JOUR CONCERNANT LES PROGRES DE LA RECHERCHE, ESSAIS SUR LES HUMAINS, TRAITEMENT POUR GUERIR LA PARALYSIS SUITE A UNE LESION MEDULLAIRE, VOIR CETTE SECTION DE NOTRE SITE : ICI

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Cette synthèse a été établie par Corinne Jeanmaire, pour la fondation endParalysis et pour le groupe de recherche de ESCIF (European Spinal Cord Injury Federation). Merci à Sam Maddox, Chris Powell (blog) et Harvey Sihota (Neurokinex) pour leurs contributions. Nous devons être clairs: il n’existe toujours pas de traitement, de therapie ou de guérison pour les lésions (chroniques) de la moelle épinière.  À en juger par le nombre croissant d’essais cliniques en cours et prévus, il semble que nous nous rapprochions toutefois un peu d’un certain niveau de récupération possible dans le futur. Les données présentées dans les onglets de cette page sont loin d’être exhaustives, mais visent simplement à donner une idée de la dynamique en cours. Nous avons divisé les données en quatre blocs, à savoir:

Attention : le but de cette section de notre site Web est de fournir un résumé des développements importants en matière de recherche sur la moelle épinière en vue de trouver un traitement curatif / une thérapie réparatrice apres une lesion medullaire. En accord avec le domaine d’activité et les objectifs de la fondation endParalysis, nous nous concentrerons principalement sur les projets de recherche actuellement appliqués ou ultimement applicables aux lésions médullaires chroniques et sur les thérapies au stade clinique ou préclinique et donc susceptibles d’être appliquées avec succès. sur des patients humains. En outre, cet aperçu est purement informatif et ne constitue en aucun cas une approbation de la fondation endParalysis ou de son comité scientifique pour un projet de recherche spécifique, un traitement expérimental ou un essai clinique.

recherche sur les thérapies, traitements des lésions de la moelle épinière 2019

recherche sur les thérapies, traitements des lésions de la moelle épinière 2019

 

PARTIE I 

REGENERATION / REPARATION: THERAPIES A BASE DE CELLULES (SOUCHES)- ET COMBINAISONS AVEC D’AUTRES THERAPIES

Mise à jour :  28 mai  2019

Cure Spinal Cord injury latest therapies research, treatments 

Post en cours de traduction !

Ces projets de recherche/ ces essais cliniques incluent des thérapies de transplantation de cellules (souches), éventuellement associées à des facteurs de croissance ou à des molécules visant à améliorer la repousse nerveuse ou des stratégies visant à la neutralisation des inhibiteurs de croissance et/ou des échafaudages de biomatériaux (« scaffolds ») pour guider la repousse nerveuse. D’autres stratégies encourageant la neuroplasticité (le remodelage des signaux du cerveau et des nerfs de la moelle épinière) sont également possibles.

 

 

1- Cellules adipeuses –  Mayo Clinic (USA) – Essai clinique Phase I (évaluation de la sureté): RECRUTEMENT EN COURS

• Contexte: Le but de cette étude est de déterminer si les cellules souches mésenchymateuses (CSM) dérivées du tissu adipeux peuvent être administrées en toute sécurité dans le liquide céphalo-rachidien de patients atteints de lésion de la moelle épinière. Les cellules souches mésenchymateuses dérivées du tissu adipeux (AD-MSC) ont déjà été utilisées dans des recherches antérieures à la Mayo Clinic, mais il est nécessaire de vérifier la sureté du traitement.

 

• Dernière mise à jour (mai 2019) : cet essai est en cours de recrutement, selon clinicaltrial.gov

 

• Participation à l’essai : Plus d’infos sur scitrials.org ici :  NCT03308565. 

 

2.- Neuralstem Inc. – Cellules souches neurales – L’ESSAI RECRUTE DES PATIENTS (États-Unis)

• Contexte : Un essai clinique a été lancé aux États-Unis en octobre 2014, sous le contrôle de la société de biotechnologie Neuralstem, principalement pour vérifier la sécurité de leurs cellules souches neurales (NSI-566), chez des patients atteints de lésions médullaires chroniques. Quatre patients ont été traités. En octobre 2015, il a été rapporté que l’implantation de cellules souches avait été sûre et bien tolérée.

 

• Dernière mise à jour (mai 2019) : le Dr Ciacci a été contacté pour une mise à jour, mais nous n’avons reçu aucun retour à ce jour. A ce jour, il est toujours indiqué sur le site clinicaltrials.gov que l’essai recrute des patients. En juin 2017, les commentaires de Neuralstem indiquaient: «La sécurité semble prometteuse, le feu vert a été donné pour traiter davantage de patients. « Cependant, pour être efficace, il faudra greffer plus de cellules ». L’Université de Californie à San Diego (UCSD) a commencé à recruter quatre autres participants présentant une lésion cervicale chronique (Asie A) complète (C5-C7, 1 à 2 ans après la lésion), afin de poursuivre l’essai selon un protocole modifié.

 

• Participation à cet essai : L’essai est en cours au centre clinique de Sanford Stem Cell Clinical Center. Les chercheurs recommandent que les participants à l’essai vivent dans un rayon de 500 km de San Diego, en raison du calendrier de suivi intensif de 60 mois. Pour plus d’informations sur l’étude de phase I sur les LM chroniques, contactez le groupe de recherche de Ciacci au (619) 471-3698, nksidhu@ucsd.edu. Pour en savoir plus sur l’essai: sur (NCT01772810) scitrials.org/

▪          Inscription des patients (mise à jour avril 2019):   Nous avons reçu la confirmation du Dr. Tabakow qu’il a déjà recruté un patient avec une blessure par coup de couteau. Son opération de reconstruction est en préparation. Ils cherchent un autre patient pour le procès. Attention: seuls les patients avec une moelle épinière sectionnée / coupée peuvent postuler à l’essai.   La coupure doit être nette, par exemple avec un couteau, et sans contusion de la moelle épinière.   Les candidats à cet essai clinique doivent aussi passer plusieurs années en Pologne, car la procédure sera précédée et suivie d’un processus de rééducation intensif et long. Plus d’informations concernant l’inscription sont disponibles ici:   https://walk-again-project.org/#/en ou sur NCT03933072▪          Essai clinique en Angleterre: Un autre essai clinique est en préparation, au Royaume-Uni, selon un protocole légèrement différent (la source des cellules olfactives pourrait être différente) et d’autres critères de sélection des patients.   Il n’y a pas encore d’information publique sur cette question.Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements4- Cellules souches du cordon ombilical + combinaisons. Dr. Wise Young – Essai clinique de phase II prévu (États-Unis)

▪          Informations de base:   À l’automne 2014, le Dr Wise Young, l’Université Rutgers et SCINetChina ont présenté des informations préliminaires issues de l’essai clinique de phase II sur l’essai des cellules de cordon ombilical + lithium mené en Chine.   Il a expliqué que même si aucun des participants chroniques ASIA A (lésion complète) n’avait amélioré leurs scores moteurs, 15 des 20 patients étaient capables de faire des pas avec l’aide d’un déambulateur pendant leur rééducation.   Vous pouvez voir une partie de La présentation de Young lors du symposium Working2Walk de 2014,  ici . L’étude a été publiée dans une revue en libre accès, Cell Transplantation.   Voir le résumé de la publication  ici .   Beaucoup de questions demeurent en suspens quant à l’ampleur de la récupération  » fonctionnelle  » obtenue.   Ainsi, la source des modifications présentées chez les patients doit être clarifiée (la combinaison de cellules souches transplantées avec des régimes de physiothérapie intensifs a rendu difficile l’identification de la source d’amélioration).

▪          Dernière mise à jour (mai 2019):   Essai clinique aux États-Unis en préparation: la FDA a approuvé cet essai clinique et débutera cette année un essai avec 27 sujets pour cet essai de phase IIb (visant à prouver l’efficacité). Il se compose de trois groupes de neuf patients, ASIA A, C5-T11 (info datée de 2018, nous n’avons pas connaissance d’une mise à jour de ces informations).   Le premier groupe souhaite recevoir des injections de cellules souches du sang de cordon ombilical, six semaines de lithium (prise orale) et une rééducation intensive.   Le deuxième groupe recevra des cellules souches du sang de cordon ombilical et une rééducation intensive.   Le troisième groupe va uniquement bénéficier d’une rééducation intensive.

▪          Inscription des patients (mise à jour mai 2019):   Cette étude est en préparation et ne recrute pas encore de patients. Afin de vous qualifier pour cet essai, vous devez avoir une lésion médullaire complète entre C5 et T11, être blessé depuis plus d’un an, âgé de 18 à 64 ans. La participation à un essai clinique est gratuite.   Mais si vous êtes sélectionné(e), vous devrez prendre en charge les frais d’hébergement et de transport dans le New Jersey (États-Unis) pendant 6 mois. Envoyez un courrier électronique à Jim Bennett qui vous ajoutera à sa liste d’alertes lorsque le recrutement commence dans un mois ou deux. jimbenn@rutgers.edu  » Source: Norcalsci.org

▪    Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

 

5- NC1 – Injection intrathécale de cellules souches de la moelle osseuse – Dr. Vaquero –   Nouvel essai annoncé pour les lésions incomplètes (Espagne)

▪          Contexte :    Dr. Vaquero (Medecin à l’   Hôpital universitaire de la Puerta de Hierro, Espagne)   étudie l’impact de l’injection intrathécale (dans l’espace sous-arachnoïdien) de cellules souches mésenchymateuses de la moelle osseuse. Divers essais de phase I / III ont été menés sur des patients atteints de lésions de la moelle épinière incompletes ou complètes.   Vous trouverez plus de détails scientifiques et de résultats détaillés dans les publications suivantes:   Publication 2016 (LME complètes)   et   la publication de mars 2017 . ASelon cette dernière publication des patients avec une lesion Asia A, B, C ont amélioré leur status neurologique pour devenir respectivement Asia B, C, D (c.-à-d. qu’ils sont devenus plus incomplet et récupérer des fonctions et/ou sensations).

▪          Dernière mise à jour (mai 2019):   Selon le journal El Mundo   (Article en Avril 2019 – traduit de l’ espagnol): « Aujourd’hui, après un long processus impliquant un petit groupe de personnes avec cette condition [LME], le développement de la thérapie [NC1] a été développée et a été approuvée par l’Agence Espagnole des Médicaments. Tout est prêt pour commencer à travailler avec 30 nouveaux patients [avec une lésion de la moelle épinière incomplète].”

▪          Inscription des patient:   Cet essai n’est pas encore publié sur www.clinicaltrials.gov et ne recrute pas encore. Attention: cet essai ne recrutera SEULEMENT des patients de 18 à 65 ans atteints de SCI INCOMPLETE .

▪    Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

 

6- Neuroplast (Pays-Bas) – MCellules souches de la moelle osseuse – Recherche clinique en préparation pour lésions médullaires chroniques et aiguës – Essais humain annoncé en Espagne et au Danemark

▪          Contexte :   Neuroplast est une société indépendante créée en 2013 et située sur le campus de Brightlands Maastricht Health aux Pays-Bas. Une étude pré – clinique a montré que les cellules Neurocells développées par Neuroplast , obtenues à partir de la moelle osseuse du patient lui-même, améliore significativement les fonctions locomotrices et la survie chez des  rats présentant des lésions de la moelle épinière par rapport à ceux ayant reçu un placebo (médicament sans agent actif). Source: http://www.neuroplast.com/. La recherche implique la transplantation de neurocellules et aura lieu dans deux centres différents: Toledo (Espagne) et Copenhague (Danemark). Les “neurocells”devraient avoir un effet positif à la fois en termes de neuroprotection et de neuroplasticité et ainsi contribuer à un niveau de récupération fonctionnelle à la fois dans les lésions de la colonne vertébrale chroniques et aiguës.

 

▪          Dernière mise à jour (mai 2019) :   Neuroplast prépare actuellement un essai clinique de phase II / III auquel 70 patients atteints de lésion (sub) aiguë ou chronique de la moelle épinière pourront participer. La phase II (16 patients) débutera à la fin de l’été 2019. La phase III (54 patients) devrait commencer 6 mois plus tard, lorsque la phase II est à mi-parcours.

 

▪          Inscription des patients: La phase I est terminée et la phase II / III de l’étude est en préparation. Le recrutement de patients n’a pas encore commencé. Les 16 premiers patients atteints de paralysie chronique devraient commencer d’ici la fin de l’été 2019. Ces patients seront recrutés autour des centres (Toledo et Copenhague) participant à l’étude.

 

 

Quelques questions ouvertes ont été envoyées à Neuroplast:

 

1. Les premiers essais (lésion médullaire chronique) auront lieu à Copenhague et à Toledo. Les patients d’autres pays sont-ils également acceptés? Blessure médullaire complète ou incomplète? Les premiers essais vont en effet avoir lieu à Copenhague et à Tolède et nous travaillons actuellement sur une clinique à Halle (Allemagne) pouvant inclure des patients à partir de la fin de l’année. Ce sont des patients qui sont déjà traités sur place, il sera donc difficile de recruter des patients d’autres pays. Cela concerne à la fois la paraplégie complète (AIS A) et la paraplégie incomplète (AIS B et C).

 

2. Les autres parties de l’étude (pour la paraplégie aiguë et subaiguë) se dérouleront-elles également en Espagne et au Danemark? Ou est-ce qu’un centre néerlandais participe? Ou d’autres pays? Les phases 2 et 3 se dérouleront dans les centres mentionnés ci-dessus. Nous espérons œuvrer pour que davantage de centres (y compris les Pays-Bas) participent à nos recherches, mais rien n’est concret pour l’instant.

 

3. « La phase I de l’enquête est terminée ». La phase I s’est-elle déroulée quelque part? Notre phase 1 est achevée sans la terminer car nous avons reçu l’indication de la CCMO (Commission centrale de la recherche humaine aux Pays-Bas) qu’il n’y a aucune conséquence pour la sécurité du patient.

7 – BioArctic – SC0806 (dispositif biodégradable + FGF1) – en phase II, recrutement de patients Suède – Slovénie

▪          Information de base : SC0806 est la combinaison d’un dispositif médical biodégradable et d’une substance médicamenteuse (FGF1) et d’un implant nerveux conçus pour soutenir la régénération nerveuse dans la zone lésée de la moelle épinière. La thérapie est développée par BioArctic AB, une société biopharmaceutique suédoise focalisée sur la recherche. BioArctic a reçu l’approbation réglementaire en Estonie pour un essai clinique chez des patients présentant une lésion médullaire complète. BioArctic a reçu des fonds du Programme de l’ Union européenne Horizon 2020 Recherche et Innovation pour mener à bien ce projet. La société développe également des thérapies pour les maladies d’Alzheimer et de Parkinson.

▪          Mise à jour (mai 2019):   En février 2019, la société a annoncé que  » le premier patient du deuxième panel de l’étude de phase I / II a été traité avec du SC0806. SC0806 pour une lésion complète de la moelle épinière a ainsi progressé dans la phase II.

▪          Recrutement de patients (LME traumatiques complètes uniquement) : L’inclusion de patients dans le deuxième des trois panels est en cours. Chaque groupe de six patients recevant SC0806 et trois patients du groupe contrôle. Le traitement avec SC0806 comprend une intervention chirurgicale. La chirurgie est suivie de 18 mois d’entraînement intensif avec un système robotique visant à soutenir la régénération nerveuse et la reconstruction musculaire dans la partie du corps touchée par la paralysie. Les patients recevant SC0806 ont ainsi la possibilité de participer à une étude prolongée de 12 mois. La premiere évaluation des résultats  à 18 mois du premier panel est prévue pour le quatrième trimestre de 2019 / premier trimestre de 2020.  » Pour en savoir plus sur cet essai sur clinicaltrials.gov:   NCT 02490501 , ou sur SCITRIALS.ORG Ou contactez:   Hans Basun, MD,   +46734411798, hans.basun@bioarctic.se

Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

8- Societe MD stemcells – Cellules Cellules souches de la moelle osseuse + Réalité virtuelle + Essai clinique de phase I : RECRUTEMENT en cours (USA)

▪          Contexte: L’étude SciExVR évaluera les avantages potentiels des cellules souches autologues de la moelle osseuse (provenant du patient lui-même). Le traitement inclut des injections bilatérales des cellules souches au niveau de la blessure ainsi que au niveau du segment rachidien supérieur et inférieur suivie d’une injection intraveineuse et d’un placement intranasal. Les patients qui suivent un traitement par BMSC peuvent également être assignés à l’utilisation d’un robot de rééducation (exo-squelette) (ou équivalent) ou de la visualisation en réalité virtuelle (ou l’équivalent) pour augmenter la reactivation des neurones moteurs supérieurs et / ou la réceptivité du neurone sensoriel.   Plus d’infos: http://mdstemcells.com/sciexvr/

▪          Dernière mise à jour (mai 2019):

▪          Inscription des patients: Plus d’informations sur scitrial.org ou contactez Steven Levy, MD   stevenlevy@mdstemcells.com

▪    Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

 

9 – Cellules IPS * – Essai clinique de sureté prévu   (PHASE 1) (JAPON)

▪          Contexte: En février 2019, le ministère de la Santé du Japon a approuvé l’utilisation de cellules souches pluripotentes induites (IPS). L’essai planifié sur l’homme se base sur les recherches expérimentales de Hideyuki Okano, professeur à l’Université Keio, et d’autres.

▪          Dernière mise à jour (mai 2019): «  Les plans prévoient un essai sur quatre patients âgés de 18 ans et plus ayant subi une lésion de la moelle épinière et dont la sensation et la mobilité corporelle ont été complètement perdues. Deux millions de ces cellules seront transplantées dans la zone lésée de chaque sujet par injection. L’équipe de recherche sera dirigée par Masaya Nakamura, professeur à l’Université Okio et Keio. La sureté et l’efficacité de la procédure seront examinées un an après la procédure et les patients suivront une rééducation pour les aider à retrouver le contrôle moteur de leurs membres. Des médicaments immunosuppresseurs seront utilisés pour contrôler le rejet des greffes.  » . Source: Nikkei Science

▪          Inscription des patients: Cet essai n’est pas encore publié et ne recrute pas encore de patients.

▪    Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

 

10- Cellules de Schwann et combinaisons – Projet de Miami – Essai actif mais sans recrutement de patients

▪          Informations de base :   Le projet de Miami a lancé son essai clinique avec des cellules de Schwann pour les patients atteints de lésion médullaire chronique en février 2015.   Les cellules greffées sont autologues (provenant du patient lui-même).

▪          Dernier statut (mai 2019 ):   L’essai clinique sur les cellules de Schwann a terminé sa phase 1 (pour vérifier la sécurité) et a montré que les cellules étaient sans danger.  Le projet de Miami fait actuellement l’objet d’autres études associant la greffe de cellules de Schwann à diverses autres stratégies thérapeutiques telles que la rééducation physique intensive.   Des études complémentaires sont donc en préparation et pourraient impliquer la combinaison de cellules de Schwann avec, respectivement, des facteurs de croissance, des anticorps et des matrices de support cellulaire.

▪          Inscription des patients : cette étude est toujours active mais ne recrute plus de patients, selon clinicaltrials.gov. Pour plus de détails,   voir ici:   NCT02354625

Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

11- Autres essais cliniques avec des cellules souches dans le monde – Résumé

▪          Chine – Guangzhou – Transplantation de cellules du cordon ombilical – NCT03505034

▪          Vietnam-Danang – Transplantation de cellules mononucléées autologues dérivées de la moelle osseuse par injection lombaire – recrutement de patients. Plus d’informations: NCT02923817

▪          Chine – Pékin – Échafaudage NeuroRegen avec greffe de BMMC ou MSC – plus d’infos: NCT02352077

▪          Chine – Beijing – Échafaudage NeuroRegen avec cellules mononucléées de la moelle osseuse (BMMC). Plus d’infos sur: NCT02688062

▪          Chine: biologique:   Cellules souches mésenchymateuses du cordon ombilical – Administration intrathécale d’UC-MSC – Plus d’informations: NCT02481440

▪          Brésil – greffe de cellules souches mésenchymateuses de moelle osseuse autologue – RECRUTEMENT – plus d’info: NCT02574572

▪          Jordanie – Cellules souches de la moelle osseuse – CD34 + et CD133 autologues, dérivés de la leucaphérèse, purifiés – plus d’informations: NCT02687672

Cure lésion de la moelle épinière plus tard   thérapies recherche, traitements

12. Autres essais actifs, mais ne recrutant pas de patients

▪          Espagne – Administration intrathécale de cellules souches mésenchymateuses étendues de gelée de Wharton – Institut Guttmann – https://scitrials.org/trial/NCT03003364

▪          Jordanie – Comparaison mésenchymateuse de moelle osseuse autologue et AT-MSC autologue. Plus d’infos: https://scitrials.org/trial/NCT02981576

▪          Russie – Transplantation autologue de cellules souches neurales par injection intraspinale et intrathécale avec matrice 3D selon les besoins – plus d’infos: https://scitrials.org/trial/NCT02326662

 

 

 

Cure Spinal Cord Injury latest therapies Research,  treatments

PART II

SCAR and GROWTH INHIBITORS REDUCTION & COMBINATIONS FOR REPAIR

Update: May 2019

Cure Spinal Cord Injury latest therapies Research,  treatments

Background information: One of the biggest issues preventing recovery after a chronic spinal cord injury is the scar that appears a few days or weeks after the injury and prevents any axon from growing away from the lesion area. One of the key scar reduction strategies involves using the Chondroitinase enzyme. Various peptides are also being tested for that purpose.

Besides, this chapter also describes a few of the various therapeutic strategies that are used to neutralize growth inhibitors (often referred to as NoGo) after the spinal cord injury, and /or promote nerve growth.

Cure Spinal Cord Injury latest therapies Research,  treatments

1- ReNetX Bio – NOGO TRAP (CLINICAL TRIAL IN PREPARATION)

• Background information: The ReNetX a.k.a. “NoGo-trap” technology is expected to allow neurons to naturally re-grow by blocking factors that inhibit such growth. Contrary to the previously known “Anti-NoGo” technology, it is proved, as per the ReNetX company representatives, to bind and neutralize 3 types of inhibitors and is not limited to the NoGo-inhibitor.The intrathecal delivery of the NoGo Trap protein delivery has shown axonal growth associated with a certain recovery of function by rats. It is reported to promote nerve sprouting and synaptic plasticity, as well as, to a lesser extent, axonal regeneration. The ReNetX company is now planning a clinical trial for cervical injury patients.

• Latest update (May 2019): ReNetX Bio is planning a phase Ib – IIa clinical trial (meant to test safety and efficacy) for patients with a chronic Cervical Incomplete injury. As far as we know the trial, expected to start at the end of 2018, has been delayed due to administrative bottlenecks having no relationship to the study itself. 

• Patient Enrolment: This trial is not published yet. The enrolment has not started yet. The milestones known so far are: IND (Authorization to start the trial): 2018 – Trial implementation: 2018-2020

2- CHASE IT: Chondroitinase and gene therapy for chronic SCI- PRE-CLINICAL stage (no human trial yet)

• Background information: The application of a bacterial enzyme called Chondroitinase, or Ch’ase, has repeatedly been proven to degrade the scar, to promote growth and to improve recovery in animal experiments. However, applying it to people is challenging. The goal of the project “CHASE-IT”, initiated by the International Spinal Research Trust (ISRT), is to make the Ch’ase therapy ready and safe for clinical application. It relies on an international collaboration between various researchers, among others in the UK and in The Netherlands. Recent experiments, using gene therapy models to deliver the enzyme, have moved the therapy closer to human application. 

• Latest Update (April 2019): Two alternative gene delivery therapies (The gene for Ch’ase is expressed in an active form in human cells and can be switched on and off to ensure an optimal and controlled delivery) have been developed/ are being tested: 

a- The chondroitinase enzyme is delivered via a Lenti-virus vector (a harmless virus). The consortium demonstrated this therapy to give rise to improved walking and unprecedented upper limb function in rodent acute spinal cord injury models. See more information in this article and video  and this Brain publication. The same treatment is currently being tested in a rodent chronic injury model (trial started in August 2018. Results will be shared in 2019). In parallel, work is carried out towards bringing this therapy to the clinics.

b- The Ch’ase enzyme is delivered via an Adeno-associated viral (AAV) vector which is already made use in other human treatments and would therefore obtain easier access to clinical trials. Various AAV vectors were created by Verhaagen’s lab and tested but they need further adjustment to retain the same functional efficacy as the LV vector.

• Next translational steps:

-The AAV vector, once optimized, will be tested in both acute and chronic SCI models (rodents).

-Discussions are carried out to test the best version of the chondroitinase therapy on humans. This is, however, a long-term goal. 

Cure Spinal Cord Injury latest therapies Research,  treatments

3-CRP (CSPG Reduction Peptide) possibly in combination with ISP– to reduce the scar –  Dr. Yu Shang Lee – Cleveland Clinic (Animal studies=PRE-CLINICAL stage)

• Background information: The formation of an enduring glial scar near the injured site leads to poor nerve regrowth capacity and poor functional outcomes in chronic stages after SCI. Chondroitin sulfate proteoglycans (CSPGs) are the major components of this glial scar. The small peptide called CSPG reduction peptide (CRP) was designed by Dr. Yu Shang Lee’s lab to meet this need. The aim of the study is to replicate and hopefully confirm preliminary results which have shown that CRP has therapeutic effects on chronic SCI in rats. CRP can be applied non-invasively by subcutaneous injection. The non-invasive character of the CRP is of great interest as it would mean that the treatment, if proven effective, will, in principle, be easily applied to human patients. This could constitute a very valuable alternative to other therapies currently under development such as Ch’ase, that requires a specific and elaborate delivery method to safeguard its effectiveness as well as safety for the patient.

• Latest update (April 2019):  Further to initial testing of the CRP on a small number rats in 2017, Dr. Yu Shang Lee’s lab carried out additional studies on a larger number of rats (T8 chronic contusion SCI), as of August 2018. The project, co-funded by the endParalysis foundation, aimed to determine the efficacy of CRP alone and of CRP + ISP (ISP is another peptide, developed in Dr. Jerry Silver’s lab, Case Western University). Starting two-month post-SCI, the treated animals received the various peptides by daily subcutaneous injection during three consecutive months.

• Results: Treatment outcome: The study shows an overall improvement in locomotor and bladder function in the treated animals. While there was a trend showing CRP+ISP works slightly better in improving BBB scores (testing stepping function) than CRP alone, there was, overall, no significant difference between the CRP+ISP and CRP groups. Importantly, both CRP and CRP+ISP groups demonstrated better hind limb / forelimb coordination).

• Conclusion: The study seems to show that CRP enhanced connectivity established across injury site and nerve sprouting below the injured site after treatment, as well as an improved both locomotion and bladder function (the CRP-treated groups show less hyperactivity, better void efficiency, and lower voiding pressures).

• Next steps: Dr. Lees indicates the following steps will include testing dose responses of CRP to see if higher dose can lead to an additional functional improvement, conducting Pharmacokinetics and Safety/toxicity tests of CRP and testing the efficacy of CRP in a large animal model with Dr. Brian Kwon using pigs T10 subacute stage injury model (two weeks post SCI) to test both locomotion and bladder function as well as in a cervical chronic SCI model (C4 hemisection) to test forelimb/hand function in collaboration with Dr. Jerry Silver.

4-Other pre-clinical studies concerning scar reduction

• UK: alternative delivery method for Ch’ase. More info: here
• CANADA: alternative  delivery method for Ch’ase.
• USA: study of non-human primates.
• USA: Rose Bengal Study by Dr. A. Parr (University of Minnesota). See January 2018 publication 

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5- DRUG ES 135 (PEPTIDE) – HUMAN TRIALS PHASE 3- CURRENTLY RECRUITING PATIENTS (TAIWAN) 

• Background:  ES135 is a recombinant human acidic fibroblast growth factor (rhFGF1) with 135 amino acids. With its effect to promote neurite outgrowth, ES135 can be applied to the medical use of repairing neuron function. The sequence of ES135 has been patented by Eusol-biotech in Taiwan, EU, China, and the United States. 

• Latest update (May 2019): A multi-center, double-blind, randomized, placebo control study as the pivotal Phase 3 clinical trial for spinal cord injury patients is on-going and is expected to finish in 2014. Phase 3 is the last Phase before a possible approval for the drug to the market.

• Patient enrolment: 100 patients with complete SCI are expected to be recruited. The patient recruitment criteria are not precise and do not indicate is the therapy is applied at the acute or chronic stage. More info: https://scitrials.org/trial/NCT03229031 

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Cure Spinal Cord injury latest therapies Research, treatments

PART III

ELECTRICAL /MAGNETIC STIMULATION/TMS AND BMI/BCI

Update: 24 May 2019

Cure Spinal Cord injury latest therapies Research, treatments

Background information: E-stim (this term can refer to neuromodulation, neuro-stimulation, epidural stimulation), Magnetic stimulation, TMS (Transcranial Magnetic Stimulation) and BMI /BCI (Brain Machine or Computer Interface); all these technics use different protocols, involve various levels of invasiveness and produce various outcomes. However, all of them are exploring the automaticity of the spinal cord and then trying to tap into it.  As per Dr. Reggie Edgerton: “Neuro-stimulation is the process of using gentle electrical currents to stimulate the spinal cord below the point of injury, enabling nerve circuits in the spinal cord to ‘hear’ and act upon messages coming from the brain.”  Based on various studies, those techniques seem to generate light functional return as well as (maybe) some improvement of the patient’s autonomic function (but beware that this “improvement” is mostly anecdotal and has not been the subject of many scientific publications yet).

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1-Epidural Stimulation with an implanted (Medtronic) stimulator- Many clinical trials ongoing/recruiting or planned: 

• Background information: The patients receiving this kind of therapy undergo a surgery to transplant the electro-stimulation device (until now a Metronic electrostimulator, the same one as used for fighting neuropathic pain) over a certain part of the spinal cord (the section of the spinal cord stimulated with electric current differs depending on what the aim of the therapy is, for example, motor functions or bladder and bowel/ sexual function). Electro-stimulation of the cord is not a new system and was already used in some studies in 2000. However, the very first results of epidural stimulation with the Medtronic device were communicated in 2014. Since then many large scales clinical trials have begun and more are planned in various part of the world to check the isolated results published before. From the results known so far, E-stim should not be seen as a cure but rather as a way to enhance the quality of life. It does not repair the nerves but rather seems to stimulate the remaining connections. The interesting part of e-stim is that, in some limited cases, the (however limited) motor functions obtained through the stimulation when the e-stim device is on are actually seen to continue (for a limited time) after the device is switched off.

• Latest update (May 2019) / Results published/ documented so far:

• • July 2015 (Dr. Harkema-Louisville- 4 patients- scope: motor control)– result for the first four patients were published (for more info click here).  Two patients had a motor and sensory complete injury (ASIA A) whereas two patients had a sensory incomplete injury.  After some physical training, patients were able to stand up and take steps when the stimulator was activated.  Is this a full recovery?  Negative, it is important to understand that movement of the limbs is only possible when the stimulation device is activated and even though patients can move their legs on command, it is not substantial enough to be labeled as “really walking.”  Nevertheless, and this is the most interesting aspect of the study, these patients have all reported having obtained some significant autonomic recovery.  That includes bowel, bladder, sexual function, and temperature control.  Unfortunately, as this data was neither published nor documented, it is difficult to assess whether the outcome can be measured as merely a slight improvement or full control.

• • May 2017 (Dr. Edgerton- a study on rats with Cervical injuries): the study highlights that e-stim may help people with a cervical injury to improve their grasp function, but it was conducted on rats only. Read more: here.

• • November 2017 (Dr. Harkema – scope: Autonomic functions, including bowel-bladder and sexual functions): A poster was presented at the Neuroscience conference expanded a bit on the effect of e-stimulation on autonomic, including bowel- bladder and sexual improvements. The poster remained rather vague about the range of improvement though and conclusion read: “Spinal cord epidural stimulation, along with activity-based training, may help provide an appropriate level of excitation to the spinal cord, targeting the neural circuitry involved in urogenital and bowel function”. More info: here.

• • October 2018 (Dr. Courtines – EPLF Switzerland and GTX Medical- results for 3 incomplete SCI patients): the study shows that targeted electrical epidural stimulation coupled with an intensive regimen of locomotor training can help people with incomplete spinal cord injury improve their mobility. More details in our article here.

• • October 2018 (Mayo Clinic – EES results for 1 patient): Nature Medicine reported that a single patient with a spinal cord injury at the Mayo Clinic was also able to take steps and walk with trainer assistance thanks to electrical stimulation and intensive physical therapy. Beware: in this study, the e-stim has to remain on for the subject to take a step. The electric impulse given by the surgically-implanted stimulator is necessary to take the step. More details in our article here

• • October 2018 (Dr. Harkema – University of Louisville. Results of Epidural Electric Stimulation + intensive training for 4 patients): According to the Louisville publication, all four patients treated achieved independent standing and trunk stability (with the stimulator on). One of them can actually walk a short distance on her own, with the stimulator on and with the use of a walker. Beware: the patient with the best outcome had a motor-complete, but sensory-incomplete spinal cord injury (she had sensation below the level of her lesion, which is not often the case and does indicate that a number of nerve fibers are actually intact). Beware: in this study, the e-stim has to remain on for the subject to take a step. The electric impulse given by the surgically-implanted stimulator is necessary to take the step. All details in our article here

• • March 2019 – publication by Dr. Darrow (Minnesota). First results of the E-stand trial – for two women with a complete SCI): What is outstanding in this study is that the therapy includes e-stim but does not include any particular physio-therapy regimen. The results in the field of locomotion seem to be in line with results reported so far (i.e., the ability to move limbs on command when the device sends impulses). In both cases, significant quality of life improvement is reported through a level of autonomic function improvement. More interestingly, one of the two women reported that she can now experience orgasm when the device is on. More info: here

• • December 2018 (Dr. Krassioukov, Canada- single patient (with motor-complete but sensory-incomplete injury. Scope: bladder and bowel function). The 2018 publication mentions a positive effect of neuromodulation applied on the lumbosacral cord to modulate autonomic circuits involved in the lower urinary tract and bowel control after SCI. The study reports improvement of both urinary tract and bowel routine for this single patient, for example in terms of urodynamics (which could also result in a lower risk of a bladder infection) and a much shorter time needed for bowel routine. Although this improvement can be of value in terms of quality of life and care, rather than in terms of actual recovery, the study does not show an actual full recovery of the bowel and bladder function.

.

• Patient enrolment (update May 2019):

• • Minnesota – 100 patients: According to the E-stand website, the trial is still recruiting patients with a chronic (>1 year) injury at C6-T10 level with Asia A (complete SCI) or Asia B rating (incomplete SCI).  Please check other details and important inclusion criteria here: NCT03026816

• • UCLA (California, USA). This study is focused on hand function recovery after implantation of an epidural stimulator in chronic cervical injury patients.  Click here for more details: NCT02313194

• • Vanderbilt University (Nashville, Tennessee). This study is meant to measure the effect of epidural stimulation on mobility for chronic SCI patients:  Click here for details: NCT02899858

• • University of Zurich (Switzerland). This study checks the effect of Epi-Stim on bladder control.  Click here for details: NCT02165774 – Patient recruitment status: completed.

• • Kentucky (The Big Idea/ Dr. Harkema): It is not clear whether this project (36 patients anticipated) for which Reeve foundation has been raising funds since 2014 is actually (still) recruiting patients nor how many patients are already enrolled or what results have been obtained so far.

• • Switzerland (Stimo- Dr. Bloch, Zwitserland/ GTX Medical) is still recruiting participants with an incomplete spinal cord injury (ASIA C or D–level T10 or higher).  Most patients have already been recruited and have received the therapy (see the first results above) but this trial is still shown as recruiting. Be aware: participants have to be ready and committed to going for five to six complete months of intensive therapy in Lausanne (Switzerland).  See more details and conditions here: NCT02936453
  • Europe – future steps (Medium term) planned by GTX Medical (Switzerland and The Netherlands – Dr. Courtine). The company is currently developing two products:  one is a fully dedicated implantable spinal cord stimulator, and the other one is an overground body weight support platform, together with rehab equipment company Motek, who will further commercialize the latter product. According to GTX’ CEO Sjaak Deckers, the therapy in preparation is very promising and will largely increase the chance of people with an incomplete spinal cord injury to get back on their feet.  However, quite some time is still needed until the therapy becomes available at large.  Two to three years will be needed before GTX Medical can start a large-scale clinical trial involving many more patients from 4 to 5 rehabilitation centers in Europe.  After that, a few more years will pass until the treatment is available on the market.
  • Europe – STIMO 2 study: GTX Medical and the Sint Maarten Kliniek in Nijmegen (the Netherlands) recently announced that a study was expected to start and will recruit people who have just acquired an incomplete spinal cord injury at T10 or higher. Be aware: ACUTE (very recent) and INCOMPLETE injuries only. This study is expected to start around September 2019, in Nijmegen.

2-Transcutaneous e-stim (non-invasive): RECRUITING PATIENTS

• Background information: Transcutaneous E-stimulation is more or less based on the same working principles as Epidural Stimulation.  However, transcutaneous stimulation does not require any surgery since the device works through the skin.  The treatment is thus non-invasive, which is a big advantage vs epidural stimulation, and is therefore considered as risk-free* for the patients.

(*) Risks:  it has to be stressed that one patient, however, has reported a dramatic increase in his neuropathic pain after the treatment.  There is no other such case reported to-date and this can probably be considered as an exception, albeit a painful one.

• Latest update (update May 2019): It is a (not so) well-kept secret in the field that the NRT company who was raising funds to be able to develop and carry out a transcutaneous stimulation clinical trial in the USA might be merging with another company in the field of EES. Meanwhile Dr. R. Edgerton just founded another start-up company with just the same goal: SpineX. Professor Edgerton now also spearheads a program in Australia along with Professor Bryce Vissel. It is not clear yet if that program will be focusing on solely transcutaneous e-stim or a combination of various kind of e-stim.

• Latest results (update May 2019):

• • July 2015: Dr. Reggie Edgerton’s group and NRT reported that five men with motor complete spinal cord injuries (two to six years after the injury) improved voluntary “locomotor-like” function.  The experiments involved a transcutaneous stimulator in combination with an oral drug already approved for anxiety disorders. See the press release and video here and the scientific publication here.  It is worth noting that the so-called “locomotor-like” movements obtained through this method are not functional since they are carried out without any weight bearing.  It is, however, an impressive result given that it occurred without any surgery.  This external stimulator technology is expected to be complementary to the implanted stimulators currently tried by other groups.

• • May 2019 -From the Recovery Research Program website: “In a world-first, Professor Edgerton and his team have re-awakened the spinal cord and successfully restored feeling and function to more than 20 paralyzed people using non-invasive neurostimulation. Six of his patients have recovered hand movement, bladder and bowel control, sexual function and the ability to stand – unprecedented results in the history of medical science.”. As far as we know though, there is no scientific publication yet published regarding these results. The recovery of some level of hand movement and ability to stand, with the stimulator on, is a rather clear and expectable result from sending an electric impulse through the stimulator. However, the website does not say what status the patients were in before the therapy (i.e., acute or chronic SCI – Complete or Incomplete SCI). Also, we can and should remain cautious as to “recovered bladder and bowel control, sexual function”, a concept which is so far not accurately defined or proven and might differ greatly from patients’ expectations.

• Patient enrolment (update May 2019): A few clinical studies using transcutaneous stimulation are underway or planned in various countries:
  • Switzerland – Second panel of the Stimo study – Dr. Bloch- University of Zurich Beware: patients with INCOMPLETE SCI only – Click for details: NCT03137108
  • The USA – UCLA: This study focuses on the potential improvement of bladder control following transcutaneous stimulation: NCT02331979
  • USA – Shepherd Center NIH: Only recruits patients with an Incomplete SCI level T12 and above.  Click for details: NCT02340910
  • Australia- Recovery Research Program (previously Project Edge:  UTS and Professor Bryce Vissel). The Program is being spearheaded by Professor Reggie Edgerton and Professor Bryce Vissel, who lead an international team of world-class scientists and health professionals at UTS’s Centre for Neuroscience and Regenerative Medicine. It is the first comprehensive and clinical enterprise outside the United States of Professor Edgerton’s ground-breaking research into neurostimulation to re-awaken the spine and successfully restore feeling, function, and movement in spinal cord injury patients. This program is expected to start and to recruit patients soon.

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3- Transcutaneous Magnetic stimulation of the lower spine (non-invasive) for improved bladder function- Dr. Lu – UCLA (USA)

• Background information:  In August 2018, neuroscientists were reported to have restored « significant bladder control » by five men with spinal cord injury. “We were excited to see a positive effect in all five patients after only four sessions of mild magnetic stimulation,” said Dr. Daniel Lu, the study’s principal investigator and an associate professor of neurosurgery at the David Geffen School of Medicine at UCLA. “The benefit persisted from two to four weeks, suggesting that the spinal cord’s neural circuitry retains a ‘memory’ of the treatment.”  While magnetic stimulation is quite similar to e-stim,  Lu’s team used magnetic stimulation because it’s noninvasive, painless and less costly than an electrical implant. Source: see this article

 

• Latest update/Results so far (Update May 24, 2019): « All five of the men regained the ability to urinate on their own during stimulation,” Lu said. “One patient — 13 years after his injury — was able to completely stop using a catheter and empty his bladder several times a day, up to four weeks after his last treatment.” For more detail see the August 2018 scientific publication here. The conclusion of that publication is that « neuromodulation of spinal micturition circuitry by TMSCS may be used to ameliorate bladder function ».The ability to urinate at will improved in each patient. Four of the men still had to use a catheter at least once each day — but that was still a significant drop from their average of more than six times a day before the treatment.

 

• Patient enrolment (Update May 2019): To our knowledge, many more patients have undergone the therapy and have shown progress. We are not aware of the current recruitment schedule but the clinicaltrials.gov website shows a still active trial in that field. See scitrials.org NCT02331979

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4-Transcranial Magnetic Stimulation (TMS) or Deep Cranial Stimulation – RECRUITING PATIENTS

• Background information: TMS uses electromagnetic induction to generate electrical currents in the brain and down the spinal cord.  Some recent studies by the University of Helsinki have shown that TMS could help patients acquire new voluntary movements and perform those movements for a while, even when the stimulation was turned off.

• Latest update (May 2019): There are several studies underway (see below) in Cleveland, Boston and elsewhere in the world to evaluate TMS therapy spinal cord injury and other nervous system disorders.

• Patient enrolment: Various trials are recruiting patients:
  • University of Miami NINDS: NCT02446210
  • Cleveland Clinic (recruiting incomplete quadriplegic patients only): NCT01539109
  • Shepherd Center (recruiting quadriplegic patients only): NCT02611375
  • Bronx VA Medical Center (recruiting quadriplegic patients only): NCT02469675 – This trial is shown as completed – results have not yet been published
  • University of Zurich (recruiting patients with an incomplete SCI, T10 and above. The study tests the effect of deep-brain stimulation on locomotion): NCT03053791
  • University of Sao Paulo General Hospital (Brazil): active but not recruiting patients. For incomplete SCI patients only: NCT02562001
  • University of Sao Paulo (incomplete SCI only to check sensorimotor improvement after TMS. Be aware: inpatient rehab in Paraiba, Brazil) NCT02899637 – Trial status is unknown

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5-Brain-Machine Interface (BMI) – Walk Again Project (WAP) – Dr. Miguel Nicolelis in Brazil

• Background info: We regularly hear about paralyzed people being able to move a limb “just” by using their thought, i.e. by making use of a Brain-Machine Interface.  This was also the principle behind the experiment led and published in August 2016 by Dr. Miguel Nicolelis in Brazil (see Nature publication here). Eight paralyzed patients (out of which seven people had a complete spinal cord injury) were reported to recover partial neurologic function, both sensory and motor after a full year of training using a non-invasive BMI skullcap, along with a virtual reality training method.  As per the paper:  “Following 12 months of training with this paradigm, all eight patients experienced neurological improvements in somatic sensation (pain localization, fine/crude touch, and proprioceptive sensing) in multiple dermatomes.  Patients also regained voluntary motor control in key muscles below the SCI level […].  As a result, 50% of these patients were upgraded to an incomplete paraplegia classification. […] – As per the paper, the hypothesis is the neurological recovery results from both cortical and spinal cord plasticity triggered by long-term BMI usage. Next, to awakening dormant spinal cord nerve networks, the virtual training, which also includes bio-feedback, could also have helped the patient’s brain recover a previously erased representation of his lower limbs. More info on this website.

• Latest Update (14 May 2019): See the latest update about this project here.  According to this article: « Two patients with paraplegia regained the ability to walk with minimal assistance, through the employment of a fully non-invasive brain-machine interface that does not require the use of any invasive spinal cord surgical procedure ».

• Patients enrolment (May 2019): We are not aware of the next steps of the study.  It has to be noted that the study however exciting from a scientific viewpoint, is yet limited to a laboratory experiment on a small number of patients.  Further investigation will be necessary to distinguish the impact of the heavy training from the pure BMI effects on the patient’s partial recovery before it can be applied in “real” life.

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6- Melbourne, Australia « SWITCH » Clinical study – BMI – STENTRODE/ BIONIC SPINAL CORD – RECRUITING PATIENTS

• Background information: University of Melbourne medical researchers, with financial sponsorship of, among others, DARPA (US Defense Department) have created a new minimally invasive brain-machine interface, aimed to enable people with spinal cord injuries to move limbs with the power of thought and through the use of an exoskeleton, or bionic limbs.  More info is available in this article. The brain-machine interface consists of a minimally invasive stent-based electrode (“stentrode”) that is implanted within a blood vessel next to the brain.  The “stentrode” records brain activity and converts the acquired signals into electrical commands, which in turn lead to movement of the limbs through a mobility assist device like an exoskeleton. More info about this project in this video.

• Latest update (May 2019):  According to the website: « An early feasibility study of the safety  (phase I trial) of the Stentrode™ device in participants with loss of motor function due to paralysis from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs. The purpose of this research is to evaluate the safety of the Stentrode™ device in humans. This is an experimental device. A new medical device and surgical technique have been developed, which allows implantation of the electrical sensors without open brain surgery. The device, called Stentrode™, is a small metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent structure. It can be placed inside a blood vessel of the brain located in an area that controls movement (motor cortex). This does not involve open brain surgery. This research will be the first of its kind to be performed in humans and may help us find safer, more effective ways to introduce/implant electrical sensors in patients’ brains ».

• Patient enrolment: SWITCH clinical study (10 patients, including a few SCI patients) More info on patient enrolment here or email to christin.bird@mh.org.au

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7-BMI for quadriplegic patients- Dr. A-Louis Benabid- France – RECRUITING PATIENTS

• Background information:  The Grenoble-Alpes University Medical Center (France) and regulatory authorities have granted Dr. Alim-Louis Benabid approval to begin the clinical research protocol “Brain-Computer Interface and Tetraplegia” at Clinatec.  The research aims to demonstrate the feasibility of a patient suffering from tetraplegia due to spinal cord injury to control an exoskeleton’s movements over several degrees via an implant that measures cerebral cortex activity. The study will focus on five patients and recruitment is underway.  Leti, a stakeholder in this research, has designed a permanent electrocorticography implant called Wimagine®, unlike any other in the world.  When placed on the surface of the cerebral cortex, it can transmit the brain’s signals reliably for years. Source: www. Minatec.org

• Latest update (May 2019): The first quadriplegic patient recruited within the trial was operated upon on June 21st, 2017.  An announcement by A.L Benabid, MD, Ph.D., during the latest WSSFN Congress in Berlin. More info on the Clinatec website: here

• Patient enrolment: This trial is still recruiting patients, according to clinicaltrials.gov.  Be aware, candidates should be quadriplegic, aged 18-40 and fluent in French, among other criteria.  More info: NCT02550522

Cure Spinal Cord injury latest therapies Research, treatments

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PARTIE IV-

THERAPIES EXPERIMENTALES A CARACTERE COMMERCIAL

Cure Spinal Cord Injury Research, therapies, treatments, 2018

There is currently no cure for spinal cord injury and all therapies mentioned on this page are actually experimental, i.e. without any guarantee for results and including a certain level of risk taking.

However, the so-called Unproven/Commercial Therapies, often referred to as “medical tourism or stem-cell tourism” are even more experimental as they do not follow regulatory protocols nor do they provide any sort of transparency or scientific follow-up.  These therapies are also referred to as “commercial” because patients have to pay for them, unlike a listed clinical trial for which participation is free.

We don’t want to ignore these therapies since a lot of patients do make use of them, often at a high cost, but we do want to warn readers about the absence of proven functional results, the cost, the lack of transparency and the possible risks attached to these treatments.

How to recognize an “unproven therapy”? If the therapy is not listed under any official clinical trial registry (eg. www.clinicaltrial.gov) and if you have to pay for it, there is a big chance that the so-called “therapy” be unproven and therefore not scientifically managed.  There is currently no cure for spinal cord injury, no guarantee for success and there is always a certain risk attached to any experimental therapy. Should you however strongly desire to take that risk, we would advise you to prefer  scientifically driven studies (called “clinical trials”) as mentioned in our website rather than the so-called unproven therapies advertised on the internet.