The studies below seem to have been suspended/or are currently standby, by lack of convincing results of human trials, or due to other challenges on the path to the clinic.

Background info:

Inflammatory damage to the spinal cord after the initial injury can continue to spread outward from the lesion epicentre into surviving tissue to cause further loss of function. The development of scar tissue encases the lesion core. Soon after the injury, the scar tissue, rich in inhibitory molecules, develops into a barrier to the regrowth of the injured axons. Dr Jerry Silver and his team at Case Western Reserve University have developed a molecule, known as intracellular sigma peptide (ISP) that helps regenerating axons ignore and bypass CSPGs (powerful inhibitory molecules in the scar). When ISP was administered non-invasively via injections under the skin, it was shown to lead to greatly improved bladder function and improved locomotion in animal models (rodents) with an ACUTE spinal cord injury.

ISP has been licenced by NervGen, a publicly traded biotech with the goal to take the therapy to the market to treat various neurological conditions, including spinal cord injury.

Latest update (May 3rd, 2024):

In August 2023, NervGen announced that they have received approval to conduct a spinal cord injury clinical trial for ISP (a.k.a. NVG-291) involving both acute and chronic spinal cord injury patients. See press-release here.

Besides, a few additional animal studies had been previously announced:

– A rodent trial for acute injuries is ongoing, including a combination of NVG-291 + sub-cutaneous e-stim (electro-stimulation/neuro modulation of the spinal cord nerves, through the skin)

– A pig trial for chronic injuries has started, carried out by the Candace Floyd’s lab (University of Utah, USA), in cooperation with various partners. The trial features a combination of therapies, i.e. the ISP peptide and neuro-stimulation. 

Patient enrolment/clinical trials (update May 2024):

Nervgen Pharma is still recruiting patients. One group  includes people with a chronic spinal cord injury (min 1 year, max 10years after injury) and the second group includes people with a sub-acute SCI (10 to 49 days after the lesion occurred). Each cohort will include 20 participants. A very important selection criteria is that patients have to have some remaining functions: CERVICAL INCOMPLETE  spinal cord injury (ASIA D or ASIA E). The trial includes a placebo group (a number of participants will thus not receive the full treatment).To know more about the selection criteria, see this page:

https://scitrials.org/trial/NCT05965700

Background info:

The application of a bacterial enzyme (a protein) 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. 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.

Latest update (Oct. 2021):

Two alternative gene delivery therapies have been developed/ are being tested :

Patient enrolment/clinical trials/ next translational steps:

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

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

Background info:

PNNi refers to a molecule that is already on the market (used to treat a rare disease). It was recently tested by Dr Kwok / University of Leeds, as a potential therapy for spinal cord injury. In her animal studies, the drug has shown promising results when used at the acute (i.e. very early) stage of SCI. The molecule seems to neutralise  the PNN (PeriNeural Net)  as well as the scar, which both prevent nerves regrowth. The main advantage of this therapy, if results are confirmed and the side effects are manageable, is obviously a shorter path to the clinics, since the drug is already approved.

Latest update (August 2023):

PNNi dosing study (including chronic SCI) by the Kwok Lab: this study was co-funded by the endParalysis foundation (2020-2022) together with two other foundations, i.e.   Gusu2cure (USA) and the Marina Romoli Onlus (Italy). The purpose of the study was to check the efficacy of the treatment at the chronic stage of SCI, and to determine the minimum dosage needed to reach a significant level of functional recovery. The study has proven that the molecule does indeed enable a clear functional recovery level in rats, even long after their initial injury, which is a very good outcome. PNNi molecule is used to treat people with a rare-disease and is thus suitable for clinical use. However, the latest study also showed that the dosage needed to achieve significant functional recovery in rats is higher than the one currently authorized on the market. Before going to human trial for use in spinal cord injury, it is necessary to finetune the treatment, either by increasing its efficacy so that it can be made effective at the authorized dosage or by addressing concerns of potential side effects and gaining regulatory approval for use at higher doses. 

Patient enrolment/clinical trials/next translational steps:

For Spinal Cord Injury, this therapy is still at pre-clinical stage, with a clear objective to go to the clinics. Various studies and optimisation of the molecule need to be conducted before it is tested on human subjects with a spinal cord injury. 

Background info:

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 (a tiny organic compound) called CSPG Reduction Peptide (CRP) was designed by Dr. Yu Shang Lee’s lab (Cleveland Clinic – USA) to meet this need. The non-invasive character of the CRP (it can be applied by subcutaneous injection) is of great interest. CRP treatment, if proven effective, would in principle, be easily applied to human patients and might constitute a very valuable alternative to other scar-alleviating therapies currently under development such as Ch’ase. The endParalysis foundation and partners supported various animal studies to check the robustness, replicability and safety of the CRP therapy in order to advance it towards human trials

Latest update (October 2023):

• 2022-2023 CRP replication + combination study (Ronaldo Ichiyama’s lab, Leeds, UK): This animal study was co-funded by endParalysis and partners in 2022. The experiment was meant to check whether the behavioural improvements seen by the animals treated with CRP could be replicated by another lab, and whether they could be enhanced by the electric stimulation of the cord. E-stim through an implanted stimulator has repeatedly been shown to (slightly or significantly) improve behavioural outcomes in a number of human subjects by “awakening” the spinal cord neural connections that had become “dormant” as a consequence of the injury.
  Unfortunately, the effect of the CRP peptide was not proven by this study: there was no significant difference between groups treated with e-stim only and the groups treated with E-stim+CRP.

• 2020-2022 CRP dosing study (Yu Shang Lee’s lab, Cleveland Clinic, USA): funds were pre-allocated by endParalysis and partners at the end of 2019 for testing dose responses of CRP. The goal was to confirm previous outcome and to see if a higher CRP dose could lead to additional functional improvement, after chronic spinal cord injury. Dr Yu Shang Lee reports “We have demonstrated the efficacy of CRP treatment to repair chronic SCI by improving locomotion (in the first progress report) and lower urinary tract function. In anatomical study, we also showed the CRP treatment can reduce glial scars and enhance the sprouting of serotonergic fibers that may leading to the functional recovery”.

• 2018-2019 rodent study (Yu Shang Lee’s lab, Cleveland Clinic, USA): after a first preliminary small study with a limited number of rodents, Dr. Yu Shang Lee’s lab carried out additional studies using more rats with a T8 chronic contusion SCI.  The project, co-funded by endParalysis in 2018, aimed to determine the efficacy of CRP alone, of ISP alone, and of CRP + ISP (ISP is another peptide, developed in Dr. Jerry Silver’s lab, Case Western Reserve University). Various tests were conducted, including a combination therapy. Starting two-month post-SCI, the treated animals received the various peptides by daily subcutaneous injection during three consecutive months. Both CRP and ISP were administered at a low dose in this study. The study showed that: 

  - CRP significantly improved bladder function and locomotor function
  -The results were not much improved or changed when adding up ISP
  -The test highlighted, on the other hand, that ISP alone did not enable any functional recovery of the rats at the CHRONIC stage (although it has been proven by Dr. Jerry Silver’s lab to have a robust effect at the ACUTE stage).

   

Patient enrolment/clinical trials/ next translational steps:

Over the period 2020-2023, endParalysis’ partner (Niall’s foundation - UK) funded independent CRO (Contract Research Organization) testing of CRP including pharmacodynamics (PD: studying the action of the drug on the organism) and pharmacokinetics (PK: studying the effect the organism has on the drug). These tests are necessary for any therapy advancing to human trials. The various in vivo and in vitro experiments carried out by the CRO have unfortunately failed to show a robust reach and effect of CRP when delivered subcutaneously.

However, a study carried out by  Dr. Brian Kwon (Canada) and funded by the DoD (Department Of Defense, USA) is currently testing the CRP in a larger animal model (mini-pigs with a T10 subacute spinal cord injury), using an intrathecal administration. We are looking forward to the results of the latter study. 

Background info:

Scar reduction is an essential and critical challenge when it comes to treating chronic spinal cord injury. Therefore, many labs and researchers are currently working on the subject. Here, we simply give a non exhaustive list of  various pre-clinical studies.

Latest update (May 2024):

• USA: Biomaterial (nano-particles + Ch’ase mRNA) localized delivery in rats with acute SCI. Lab: Bill Murphy, Dan Hellebrand. More info: here (publication, 2022). This group is currently preparing an animal trial at the chronic stage of the injury.
• UK: alternative delivery method for Ch’ase. Drs Liang-Fong Wong and Nicolas Granger from Bristol’s Faculty of Health Sciences. In their studies published in 2017, researchers combined both treatments to treat rodents with spinal cord injury with genetically modified olfactory ensheathing cells to express ChABC. Following transplantation of the cells in rodent models the team were able to demonstrate the successful secretion of ChABC enzyme and removal of some of the glial scar. This led to increased nerve sprouting in the spinal cord, suggestive of successful nerve regeneration following the treatment. In 2021, this therapy was tested on dogs suffering from paralysis. According to the paper abstract, “We therefore demonstrate that cOECs (genetically modified cells from the nose) can deliver sufficient chABC (Chondroitinase) to drive modest functional improvement, and that this genetically engineered cellular and molecular approach is a feasible combination therapy for SCI. More info   here (rodent study – 2017) and here (Canine study – June 2021)
• CANADA: alternative  delivery method for Ch’ase. Dr Molly S. Shoichet. More info here (publication 2017)
• USA: Ch’ase direct delivery for non-human primates with SCI.
• USA: Rose Bengal Study by Dr. A. Parr (University of Minnesota). See January 2018 publication 

Background info: 

A first study was carried out on patients in 2019 to check the safety of mesenchymal stem cells (MSC) derived from fat tissue (autologous cells, i.e. from the patient him/herself) and to see if they could be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. The trial had unexpected results on one patient with a chronic incomplete spinal cord injury. He had already recovered some functions but was still wheelchair-bound and had plateaued in his recovery. He gained major functions back after the Adipose-derived mesenchymal stem cells (AD-MSCs) transplant. More results about this particular case to be read here. It is to be highlighted that this is only one patient and that the other patients involved in the trial have not shown similar improvements. A new trial was launched in 2020 to check both safety and efficacy of the Adipose-derived mesenchymal stem cells (AD-MSCs) intrathecal delivery (i.e. through a puncture) on more patients with spinal cord injury, complete or incomplete. This trial is randomized, meaning that not all participants will get the same /full treatment. However the crossover design ensures that the people who first receive only physical training (control group – no stem-cells), will later on be given a single injection of stem cells (six months after their injury).

Latest update (May 2024): 

The Mayo Clinic published results of their CELLTOP trial regarding 10 participants so far. Out of these 10 participants, 7 people are shown to have improved. One patient of these 7one particular patient has improved more than the 6 others. It is the patient with an incomplete spinal cord injury, for whom positive results were already shared in 2020 and who apparently continued to improve. More information can be found in this U2FP blog post or in the  April 2024 publication in Nature. 

Patients enrolment (update May 2024):

According to clinicaltrials.gov, this trial is still recruiting patients. From the selection criteria, it seems that this trial recruits patients who have had a certain level of recovery after their trauma, but who have now plateaued. For further info, go to  NCT04520373. The original target was to enrol 40 people in this CELLTOP trial but the above-mentioned April 2024 publication only concerns 10 participants. It is not known whether additional 30 patients are going to be recruited or whether another trial will be started to try and optimise the treatment.

Background info:

In October 2014, in Poland, a paralyzed man was reported to have gained recovery after some of his nose nerve cells (these were actually taken from the olfactory bulb deep in his brain) were transplanted into his spinal cord and some peripheral nerve tissue from the patient’s ankle was grafted to serve as a bridge over the lesion. Expectations of this study have to be tempered since we are now talking about a single patient. However, he went from complete paraplegia to incomplete (Asia A to Asia C) and has regained considerable functions.  Here is a link to the published data.  This study was pioneered by the late Dr. Raisman (deceased 2016).

Latest update (August 2023):

As far as we know, one patient had been recruited and operated upon in 2019, but the outcome of the treatment has not been communicated nor published. The clinical trial would follow the same protocol as the one applied to the original patient, i.e. extraction of olfactory cells from the olfactory bulb in the patient’s brain, transplantation into the spinal cord along with a peripheral nerve graft.  One more chronic SCI patient is still being recruited for this clinical trial taking place in Poland (Dr. Tobakow).   The Walk-Again website concerning this trial has not been updated for a few years but the Nicholls Spinal Injury Foundation communicated  some delays in their 2020 newsletter:” […] challenges faced by the Walk Again Project in Poland in 2019. The nature of the work means the project must adhere to EU legislation issued by the European Medicines Agency (EMA). In order to meet the strict criteria, new high-tech equipment and upgrades to the laboratory were required. All equipment has now been purchased; it is just the complicated work on the ventilation system that remains. This work is being carried out by the Wroclaw Medical University and as such is outside of our direct control”.

Patient enrolment (clinical trials)- update August 2023:  

– In Poland: Only for patients with a transected /severed spinal cord.  The cord must be clear-cut, for example by a knife, not contused.  Also, the candidates for this clinical trial are required to spend several years in Poland as the procedure will be preceded and followed by an intensive and lengthy rehabilitation process. More info regarding enrolment is available here:  NCT03933072

It is not clear whether this trial is still ongoing or not. The website that was previously created to recruit patients is not online anymore, and the clinical trial page has not been updated since 2021. We sent Dr Tabakov an email asking for an update. Unfortunately, his email address also seems to be inactive and our email bounced back.

 – In the UK: complementary research on OEC’s – Another clinical trial is in preparation, in the UK, following a slightly different protocol (the source of the olfactory cells might be different) and other patient selection criteria.  There is no public update available regarding this UK trial plan but it might involve acute injuries rather than chronic ones. One publication was made regarding the combination of OEC’s transplant with a biomaterial, and concludes the following (based on an animal study):
“Combination of OECs with biomaterials such as collagen increases the transplant size significantly without affecting the neural repair capacity of OECs. This improves the prospect of transplantation of OECs to bridge a larger surface area of injured spinal cord such as those seeing in human contusion injuries. Elongation of OECs guided nanofibers providing directional pathways may be more efficient in promoting regeneration of nerve fibers in spinal cord injury.” Read more here. This research study was funded by, among others, the Nicholls Foundation

Background info:

In February 2019, Japan’s health ministry approved the use of induced pluripotent stem cells (*IPS). IPS cells are created by reprogramming cells from body tissue to revert to an embryonic-like state, from which they can develop into other cell types such as nerve cells. They are shown to have regeneration potential comparable to embryonic stem-cells but do not involve an embryo, hence being far less controversial. The ongoing human trial comes after experimental transplants into monkeys by Keio University professor Hideyuki Okano and others succeeded in restoring motor function so that the animals could walk. In a Sept. 2021 scientific publication, we learned basic information about the upcoming human. In January 14th, 2022, the very first patient is reported to have had the surgery and to be doing well. According to France24, “The patient will be monitored by an independent committee for up to three months to decide whether the study can safely continue and others can receive transplants”.

Latest update (May 2024):

The outcome of the first human transplant of human iPS cell-derived neural stem/progenitor cells (iPSC-NS/PCs) into a patient with subacute spinal cord injury (SCI) is not yet published.  In an interview (May 2022) it was confirmed that this first trial would include four patients. It is not known whether more than one patient has been operated upon yet.

 About the mechanism of action of the IPSc, Dr Okano says: “When we talk about “regeneration,” we are talking about making something “occur again.” By transplanting neural stem cells into the spinal cord, developmental events involving neurons, astrocytes, and oligodendrocytes can be repeated. In this way, we can do many things. We can reestablish interrupted neuronal circuits or supplement axons with glial cells and reestablish myelin sheaths. We can take once damaged skin, repair its structure, and restore its functionality.”

The researcher also mentions that the team also works on chronic spinal cord injuries and that they are developing a slightly different type of IPSc’s for that purpose.

A Dec 1st, 2022 publication  explains the mechanism of action of the IPSc’s and the conditions on which such transplants might have positive effects on chronic spinal cord injury, i.e. if combined with other therapies.

Patient enrolment/Clinical trials:

This trial is not published yet in clinicaltrials.gov. Three more patients are expected to be recruited, two to four weeks post-injury. To our knowledge, only one patient has received the IPS cell transplant yet, and is currently monitored for safety (this small trial’s purpose is mainly to assess whether the treatment is safe).

Background info:

Neuroplast is an independent company founded in 2013 and is located on the Brightlands Maastricht Health Campus in The Netherlands. A preclinical study showed that Neurocells, the product of Neuroplast obtained from the patient’s own bone marrow, significantly improved both locomotor functions and survival in rats with spinal cord lesions compared to rats treated with placebo (drug without an active agent). Source: http://www.neuroplast.com/. The research involves the transplantation of Neurocells and will take place in two different centers: Toledo (Spain) and Copenhagen (Denmark). The Neurocells are expected to have a positive effect both in terms of neuroprotection and neuroplasticity and thus to contribute to a level of functional return in both chronic and acute spinal cord injury.

Latest update (May 2024):

– Results from the Phase I trial (safety):  Neuroplast’s website confirms that the therapy has shown to be safe. It also mentions that “three patients [with chronic SCI] from their safety trial reported favourable effects. These include improved bowel control, sensory improvements and increased muscle tonus. One patient improved from a complete lesion to an incomplete lesion”.

– phase II/III (efficacy) trial: In September 2023, the company reported that 16 patients had been treated and that the first results of the trial would be known in February 2024, with a full study completion expected in August 2024. “The intervention group received Neuro-Cells® in the sub-acute phase after sustaining trauma, with six months follow-up to their primary endpoints. The placebo group received a placebo at first but have been or will be treated with Neuro-Cells® after the initial six-month follow-up period”.

No further results have been published yet by May 2024.

​

Patient enrolment/clinical trials (update May 2024):

The Phase II trial (aiming to check efficacy), involving people with a traumatic acute / sub-acute spinal cord injury (6-8 weeks after lesion) is till active but not recruiting anymore in Spain. It is not clear whether patients will be recruited in Denmark. More info on NCT03935724.

Chronic SCI:  at this moment we do not know if another specific clinical trial will be organized for patients with a chronic spinal cord injury. However, it is interesting to highlight that the trial that just started will recruit patients in their sub-acute phase (6-8 weeks after SCI) but will also test whether the therapy works during the chronic phase. Indeed, the protocol is designed in such a way that the patients who are in the control group get a placebo (no stem-cell treatment) at sub-acute stage, but they do get the stem-cell treatment six months after injury. So, although chronic SCI patients will not be able to enrol this trial, it will nevertheless test the therapy at chronic stage thanks to this “early and late intervention cross-over design”. 

Background info:

In the fall of 2014, Dr. Wise Young, Rutgers University and SCINetChina, presented some preliminary information from the Umbilical Cord Blood & Lithium Phase II clinical trial that had taken place in China.  He explained that although none of the chronic ASIA A participants had improved motor scores, 15 out of the 20 patients were able to take steps with the aid of a walker whilst in rehabilitation.  You can view a part of Dr. Young’s presentation during 2014 Working2Walk symposium, here. The study has now been published in an open access journal, Cell Transplantation.  See abstract of the publication here.  A lot of questions remain as to the extent of “functional” recovery obtained (is it functional even though the motor scores of patients have not improved, meaning that they cannot contract any muscle on command?).  Also, the source of the changes shown in patients needs to be clarified (the combination of stem cell transplant with an intensive physiotherapy regimen made it difficult to identify the source of improvement).

Latest update (MAY 2024):  the latest information collected from CareCure forum indicates that Dr Wise Young is still raising money to make the trial happen in the USA and hopes to start in this fall (2023).  

In a presentation (Sept. 2021), Dr. Young indicated that the USA trial would now involve more patients (40 people) and include a control group (a number of patients who will NOT receive the stem-cell treatment). Another change compared to previous plan is that no lithium treatment will be included for any patient to simplify the protocol. The latter will only include the UCB stem-cells and/or the intensive physiotherapy.

The trial was expected to start in January 2022. However, it was announced that StemCyte, the company providing the stem-cells, pulled out of the USA trial. As a consequence, the team has to find a new source of umbilical cord blood stem cells and has  to go through the IND approval process from the beginning. The FDA is requiring an additional study to prove the new sources of cells are also safe and effective. 

Patients enrolment (update May 2024):

There is no update known after August 2023. This study is in preparation and is not recruiting patients yet. These are the recruitment criteria as previously communicated (beware that they might have been adjusted): in order to qualify for this trial, you must have a complete injury between C5 and T11, be injured more than 1 year, 18-64 years old. There is no cost to participate in a clinical trial, but if selected, you would have to cover the cost of lodging and transportation in New Jersey (USA) for 6 months. For more info, email:  sciproject@dls.rutgers.edu”

PS: the biotech company who pulled out of the clinical trial plan has actually launched their own clinical trial, and is currently recruiting patients in Taiwan. A USA trial location (in New Jersey) is mentioned in the trial data, but is not yet recruiting. More info here: NCT03979742

Background info (Nov 2021):

A scientific paper was published in 2021 featuring “Dancing Molecules” and their ability to “reverse paralysis”. The focus of the experiment was on rodents with a severe acute SCI. A video shows rats walking again 4-6 weeks after the injection (though their movement is by far not back to normal, so the term “reverse paralysis” seems to be overrated. The discovery, by Dr Samuel Stupp (North Western University) attracted major media attention. This “injectable therapy” is based upon “super-molecular chemistry” and nano-medicine (the injected material looks like water, but it contains nano-filaments/ nano-fibers and turns into a gel as soon as it touches the body cells). Super-molecules are an ensemble of thousands of molecules brought together. The injected molecules are also specially designed with signals. In the spinal cord, cells have receptors on their membranes and are constantly moving. So, the therapy is also designed to allow the injected molecules to move and follow the spinal cords cells. The researchers claim that the therapy have the following five effects (for rodents, in an acute SCI setting):

– regenerating axons after an severe acute spinal cord injury
– enhance vascular growth (blood vessels inside the cord)
– remyelinate the axons
– save a lot of motorneurons (necessary to enable movement)
– diminish glial scar.

Latest update (May 2024):

In October 2023, an article was issued by the Northwestern University and Northwestern Medicine to inform about latest development in Stupp’s lab. It refers to latest in-vitro studies highlighted in an October 2023 publication. The latter publication shows that a molecular “scaffold” capable of enhancing electrical activity and growth in neurons, which may prove useful in treating spinal cord injuries.  

In January 2023, a paper from Stupp’s lab was published. The in-vitro experiment described shows the advantage of combining his dancing molecules (the bio-scaffold) with iPSC’s (induced pluripotent stem cells, ie a type of stem cell made by genetically reverse-programming a human skin cell to become a neuron. 

In September 2022, during the U2fp symposium, Dr Stupp indicated that the rodent was already successfully replicated by another lab, in France. His own lab carried the study on mice and the French lab did it on rats with acute SCI. The same recovery level was observed. Hopefully,  the results of the replication study will be published soon. 

What about the path to the clinic and chronic spinal cord injuries? In various interviews early 2022, Dr Samuel Stupp indicated that his goal is to test the therapies on humans. His lab has received a funding to prepare for the IND (application to the FDA to review and possibly authorise the therapy to be tested on humans) and to test the therapy in chronic settings. Since this treatment involves a really big number of molecules put together rather than a single molecule, it will be interesting to see how the FDA responds to this proposal. According to Dr Stupp, it is likely to be considered as one single molecule and should not face any issue. Another interrogation remains as to how the injection would be made into the human spinal cord. Would it be an injection through the dura (the envelop protecting the spinal cord)? Dr Stupp indicates that the matter has been discussed with various neuro-surgeons and that delivery strategy is the most likely.

Besides, Stupp informs that he is determined to test the therapy on chronic SCI as well, which is a good news. However, no timeline is known so far.

Patient enrolment/ Experimental trial- NOT YET:

The lab’s target is to go to clinical trial with the therapy. However, given the innovation level of the treatment, it can be expected that it will take quite some time to actually start human trials.

Background info (May 2024):

Mend The Gap is a very interesting approach to spinal cord injury repair. It takes into account the huge complexity of SCI and the need to leverage knowledge across various disciplines to develop a combinatory treatment. “Bringing together scientists, engineers, clinicians, translation specialists, and the spinal cord injury community, to address the grand challenge of repairing the spinal cord after injury”. A  CAD 24 million grant has been allocated to The Mend The Gap platform by the Canadian federal government.

Latest update (May 2024):

To date, the biomaterial platform is still under development. It is not known whether a roadmap is available towards bringing a therapy to the clinics. The Mend The Gap website, however, does include information about four themes that the team is focusing upon:   

Theme 1: Biomaterials Bridges The manufacturing of injectable biomaterials that provide a soft scaffold to guide the regeneration of nerve fibres.

Theme 2: Combination Treatments The combination of drugs, rehabilitation training and electrical stimulation to (a) promote axon growth, (b) mitigate scar tissue formation, and (c) enhance the integration of grown axons into functional spinal circuitry.

Theme 3: Imaging & Injection The development of a method to inject biomaterials into the spinal cord without causing further damage, using biomedical imaging and artificial intelligence. 

Theme 4: Ethics & Translation The understanding of human preferences and values to help us identify the most suitable individuals for an experimental spinal cord injury treatment. Also, new methods to develop literacy around the treatment and to communicate it effectively to support decision-making.

Patient enrolment/ clinical trial: 

The target of “Mend The Gap” is to accelerate research towards finding a cure for spinal cord injury through knowledge sharing. It is not know, at this stage, whether and/or when this will lead to a therapy and to human trials.

Background info:

The following very short video explains the background of the current therapies being developed at EPFL, Switserland, with the involvement of G. Courtines, M. Anderson and J. Squair. 

https://youtu.be/tdUv-9nUqGM

Latest update (March 2024):

This chapter is going to be updated soon.

Patient enrolment/clinical trials/next translational steps:

This study is still at very early stage. The Nature publication covering this study was a proof of concept. The protocol has to be made more clinically-relevant in order to translate the therapy to humans with a chronic complete spinal cord injury.