Background info (August 22nd, 2025): 

A new clinical trial will soon recruit patients in Barcelona, Spain. It is sponsored by the Guttman Institute. The primary aim is to evaluate the safety and feasibility of a combined therapeutic approach for chronic spinal cord injury (SCI). The study will investigate whether combining the intrathecal injection of allogeneic Wharton’s jelly mesenchymal stem cells (WJ-MSCs) with transcutaneous spinal cord stimulation (tSCS) is safe and viable in individuals with chronic traumatic Spinal Cord Injury. Patients will receive 3 doses of stem-cells, at 6week-intervals

Definitions:

• Mesenchymal stem cells (MSCs): Multipotent adult stem cells that can differentiate into a variety of cell types, unlike many other adult stem cells. MSCs can be found in various parts of the body, including the umbilical cord, bone marrow, and adipose tissue (fat).

• Wharton’s jelly mesenchymal stem cells (WJ-MSCs): A specific type of mesenchymal stem cells derived from Wharton’s jelly, which is the gelatinous connective tissue within the umbilical cord. These cells are known for their ability to support tissue regeneration and reduce inflammation and fibrosis (scarring of tissues).

• Allogeneic stem cells: In contrast to autologous cells, which come from the patient themselves, allogeneic cells come from a human donor. It is not known to us why the investigators have chosen to use donor cells rather than the patient’s own cells.

• Intrathecal administration/injection: The stem cells are injected directly into the cerebrospinal fluid (CSF) within the spinal canal, specifically into the intrathecal space (the area between the membranes surrounding the spinal cord). This method allows the stem cells to bypass the blood-brain barrier and directly access the central nervous system (brain and spinal cord). Intrathecal injections are typically performed via lumbar puncture (spinal tap) and are less invasive than transplanting cells directly into the spinal cord following a laminectomy to access the cord.

• Transcutaneous spinal cord stimulation (tSCS): Neurostimulation occurs through the skin and does not involve any surgery to implant a neurostimulator. It is therefore considered not invasive.

Latest update (August 22nd, 2025): 

We will post an update here as soon as the trial starts.

Clinical Trial/ patients enrolment (update August 22nd, 2025):

The new clinical trial is expected to start recruitment in September 2025 in Barcelona, Spain, and to end in December 2028.

It is sponsored by Guttman Institute in Barcelona, Spain. This study is a phase 1/2 trial, which means that it primarily aims to evaluate the safety and feasibility of a combined therapeutic approach for chronic spinal cord injury (SCI). It might also show efficacy.

All participants will receive active treatment with 12-month core follow-up + 2-year extended safety monitoring.

The key selection criteria are:

Participants with a chronic but relatively recent spinal cord injury (1 to 5 years post-injury).  – Age: 16-70 – Traumatic injury,  Cervical or Thoracic lesions C1-T12) – Severity: complete (ASIA A) or incomplete  (ASIA B/ C).

According to clinicaltrials.gov, this trial is announced but has not started yet. It is expected to start in September 2025. More info can be found here: 

NCT06922890 

Background info (August 23rd, 2025): 

Stand-Up Therapeutics is a Korean bio-tech focused on the development of smart gene therapy technology. More precisely, they have developed « efficient Direct Lineage Reprogramming (DLR) technology that offer great opportunity, according to them, when compared to stem-cell reprograming. DLR enables the conversion of astrocytes cells into induced neuro, hence offering neural regeneration potential. In a 2023 publication, they highlight how gene therapy using efficient Direct Lineage Reprogramming technology can be applied to neurological diseases. The clinical trial page  states: ‘this gene therapy [is] designed to directly convert astrocytes into functional neurons within the spinal cord. In preclinical studies, STUP-001 demonstrated both successful astrocyte-to-neuron conversion and meaningful improvements in motor function ».

Latest update (August 22nd, 2025): 

Stand Up Therapeutics is now recruiting patients in Seoul, Korea. The study is sponsored by Yonsei University This is a Phase I/II clinical trial primarily designed to assess the safety of the treatment, with efficacy also being evaluated. The full completion of the study is expected by the end of 2027.

Patient enrollment (update as of August 23, 2025):

According to ClinicalTrials.gov, the trial has now commenced and is actively recruiting 9 patients aged 19 to 60 years with chronic spinal cord injury (SCI), classified as AIS-A (complete injury) or AIS-B (incomplete injury).  

Including the screening phase, each participant will undergo a 7‑month evaluation period, during which safety, tolerability, and preliminary efficacy endpoints will be closely monitored. Further details are available on NCT06922890 .

Background Information (updated August 28th, 2025)

XellSmart, a leading biotechnology company based in China, pioneers first-in-class, off-the-shelf iPSC-based treatments for Parkinson’s disease, ALS, and spinal cord injury. Its allogeneic induced pluripotent stem cell (iPSC) therapy has entered a global Phase I clinical trial, approved by both the US FDA and China’s NMPA. This therapy aims not only to repair, but also to regenerate neural cells in damaged spinal cords, with the potential to restore lost function. More information: PRnewwire.

Definitions:
Allogeneic stem cells: In contrast to autologous cells, which are derived from the patient, allogeneic cells come from a human donor.
Induced pluripotent stem cells (iPSC): Adult cells that have been reprogrammed to regain pluripotency, allowing them to differentiate into various types of cells, similar to embryonic stem cells. A small clinical trial in Japan has already demonstrated that iPSCs appear safe and may contribute to significant recovery in individuals with recent spinal cord injuries.

Latest update (August 28th, 2025):

As of July 2025, a Phase I clinical trial has been initiated to evaluate the safety and tolerability of XS228 (iPSC-Derived Motor Neuron Progenitor Cells) in patients with subacute spinal cord injury. According to recent reports, the first SCI patient has received this therapy through the clinical trial.

Patient Enrollment / Clinical Trials – RECRUITING PATIENTS IN CHINA (August 28th, 2025 update)

This trial is expected to enroll 12 patients with C4 to L2 spinal cord injuries, including both complete and incomplete injuries (ASIA A/B/C). The study location is Guangzhou, China.
Important: This trial does not apply to patients with chronic SCI. Eligible participants will be selected within 2 to 8 weeks after injury.

Learn more about the inclusion criteria here: NCT06976229

Background info (August 2025):

The RISE-UP project is a European research initiative focused on developing a new treatment for spinal cord injury by combining stem cells with a special electrically stimulated scaffold. The idea is to implant stem cells into the injured spinal cord, then use precise electric pulses to encourage the stem cells to turn into nerve cells and integrate with the injured tissue, promoting repair. The project involves a team of scientists, engineers, and clinicians from Italy, Spain, and France working together to create and test this innovative technology.

Latest update (August 2025):

As of the latest update, the RISE-UP team has successfully developed a prototype of the electrified scaffold and is in the process of testing it in the lab to understand how different electrical stimulations affect stem cell behavior. They have designed a flexible electrode that can fit the spinal cord’s shape and deliver electric pulses safely. 

Patient enrollment / clinical trial (update August 2025):

The project is still in the experimental stage and has not yet begun testing in human patients. The next steps will involve further laboratory research and preclinical studies to ensure safety and effectiveness before moving toward clinical trials in people with spinal cord injury.

Background Information (September 2025)

Scientists — including researchers from Dr. Ann Parr’s lab at the University of Minnesota — have pioneered a new approach to spinal cord repair by combining 3D bioprinting, stem cell technology, and lab-grown tissues.
Scientific publication: Advanced Healthcare Materials

This study demonstrated several key findings:

• 3D bioprinted iPSC-derived spinal neural progenitor cells (sNPCs) successfully produced functionally active neurons in vitro (in the lab).
• Transplantation of 3D bioprinted spinal cord organoid scaffolds improved functional recovery in rats with spinal cord injury (SCI).

Key Definitions

• iPSC (Induced Pluripotent Stem Cells): stem cells generated in the lab by reprogramming adult cells (such as skin or blood cells) back into an embryonic-like state.

• sNPCs (Spinal Neural Progenitor Cells): specialized cells derived from iPSCs that can give rise to various spinal cord cell types. In this study, they were embedded into a 3D bioprinted scaffold, which was transplanted into the injured spinal cords of rats. The scaffold functions as a guide or relay system, bridging the damaged area and directing new nerve cell growth.

• Organoid: a 3D cluster of cells grown from stem cells (in this case, iPSCs) that mimics the structure, development, and function of a real organ — here, a portion of the spinal cord.

Latest Update (September 3, 2025)

“Regenerative medicine has brought about a new era in spinal cord injury research. Our laboratory is excited to explore the future potential of our ‘mini spinal cords’ for clinical translation.”
— Ann Parr, Professor of Neurosurgery, University of Minnesota
Source: Science Daily

 

 

Clinical Translation and Patient Enrollment (Update: September 3, 2025)

This therapy remains experimental and is still far from being tested in human patients. The immediate next steps include:

• further in vitro research,

• additional preclinical animal studies, and

• detailed safety and efficacy evaluations.

These will be required before moving forward to clinical trials.

Limitations of the Current Animal Study (publication above)

• Timing of treatment: In the study, therapy was administered immediately after injury (acute stage). More research is needed on its effectiveness in chronic SCI, which is far more relevant to most patients.

• Type of injury: The experiments used a transection model (completely severed spinal cord). While this does occur in humans, the most common form of SCI is contusion (bruising and crushing injuries), which was not addressed in this study.

• Functional refinement: The publication notes that further optimization is required. For instance, enabling regrowth of neurons in multiple directions through the scaffold could help restore not just motor function but also sensory recovery.

Background Information (Update – August 2025):

In 2019, the Mayo Clinic conducted a first-in-human study to assess the safety of mesenchymal stem cells (MSCs) derived from adipose (fat) tissue. These autologous cells (collected from the patients themselves) were administered into the cerebrospinal fluid (CSF) of participants with spinal cord injury. The trial yielded unexpected results in one patient with a chronic, incomplete spinal cord injury. This individual, who had previously reached a recovery plateau and remained wheelchair-dependent, experienced significant functional improvement following the transplant of adipose-derived MSCs (AD-MSCs). Details of this case were published here.

It is important to note that this outcome was observed in only one patient; the other participants did not demonstrate similar improvements.

Building on these findings, a new clinical trial was launched in 2020 to evaluate both the safety and efficacy of intrathecal delivery (via lumbar puncture) of AD-MSCs in a larger group of patients with complete or incomplete spinal cord injuries. This randomized, crossover trial design ensured that participants who initially received only physical therapy (control group, no stem cells) later also received a single AD-MSC injection.

Latest Update (August 26th, 2025):

The Mayo Clinic has released interim results from the CELLTOP trial, which has enrolled 10 participants to date. Among them, 7 individuals have shown measurable improvement. Notably, one participant with an incomplete spinal cord injury—whose early progress was first reported in 2020—continues to improve and has demonstrated greater recovery than the other six responders.

More details are available in this U2FP blog post and in the April 2024 Nature publication. As highlighted in this Mayo Clinic article, Dr. Bydon emphasized that “an important next step is identifying which subsets of patients are most likely to benefit from stem cell therapies.” He further noted that research will continue with a larger, controlled trial in which patients are randomly assigned to either stem cell treatment or placebo.

Patient Enrollment (Update – August 26th, 2025):

According to ClinicalTrials.gov, the CELLTOP trial is currently active but no longer recruiting participants. Based on the published inclusion criteria, enrolled patients were individuals who had achieved some degree of recovery post-injury but had since plateaued.

Further information can be found under trial identifier NCT04520373. While the original enrollment target was 40 participants, the April 2024 Nature paper reported only on data from 10 individuals. It remains unclear whether the remaining participants will be recruited under this trial protocol or whether a new study will be initiated to expand and optimize the treatment strategy.

Background Information:

In March 2019, twelve patients with chronic spinal cord injuries (nine with paraplegia and three with quadriplegia) took part in an experimental treatment program at the International Treatment Center for Spinal Cord Injury in Kunming, China. Six French and six Chinese participants received a therapy consisting of an autologous cell growth matrix derived from adipose tissue—described as fat enabled—combined with erythropoietin (EPO). This intervention was followed by an intensive 14‑month rehabilitation program.

Although this initiative was not conducted as a registered clinical trial and does not appear in international trial registries, it is noteworthy because it was organized by a patient association on a non‑profit basis, with the aim of accelerating access to potentially promising therapies.

According to the Neurogel‑en‑Marche Association:

“All patients had an ASIA‑A score, with complete motor and sensory paralysis, including lesions sometimes greater than 6 cm. Patients continue to recover motor and sensory function even today. They have not yet reached a plateau in their recovery and continue to improve. The majority also experienced varying degrees of genito‑urinary and sphincteric improvements.”

It should be emphasized, however, that the degree of recovery varied considerably between participants, and some of the observed improvements may be linked to the prolonged intensive rehabilitation program. To date, no peer‑reviewed publication has reported outcomes from this initiative, although the French association has stated that a manuscript is in preparation. Further details can be found on the association’s website (Neurogel‑en‑Marche).

Latest Update (August 26th, 2025):

April 2025: An animal study investigating activated fat (AF) in rodents with acute spinal cord injury was published in Cells.

The study reported that AF reduced endogenous inflammation after spinal cord injury and led to significant improvements in sensorimotor function. Furthermore, activated adipose tissue appeared to restore the segmental sensorimotor loop and re‑establish communication between supra‑ and sub‑lesional spinal cord regions. These findings suggest that AF grafting may represent a promising therapeutic option for spinal cord repair following traumatic contusion in humans.

At present, however, no results have been published from animal studies in chronic SCI models, which the Neurogel‑en‑Marche Association previously announced.

Patient Enrollment / Human Trial (Update – April 2025)

The Neurogel‑en‑Marche Association is currently preparing a second experimental trial, potentially to be conducted in Europe and/or China. In a March 2024 Facebook post, the group announced plans to initiate a human study in individuals with acute spinal cord injuries. This project is reportedly being coordinated by Hôpital de La Timone (Marseille, France) and Hôpital Louis Pasteur (Colmar, France).

As of August 2025, no further official updates have been made available.

Background Information (Update – August 2025)

Poland / UK (2014–2016):

In October 2014, a paralyzed patient in Poland was reported to have regained significant function following a pioneering surgical procedure. In this approach, olfactory bulb–derived nerve cells(taken from deep within the brain) were transplanted into the spinal cord, together with peripheral nerve tissue from the patient’s ankle to bridge the lesion.

While this outcome must be interpreted cautiously given that it involved a single case, the result was notable: the patient improved from complete paraplegia (ASIA A) to incomplete injury (ASIA C) and regained multiple functions. Published data on this case can be accessed here.  

This groundbreaking work was championed by the late Dr. Geoffrey Raisman in the UK (d. 2016). A few additional patients were later treated by Dr. Pawel Tabakow in Poland, although similarly significant improvements have not been reported.

Although the related clinical trial remains officially listed as “recruiting” on ClinicalTrials.gov, the Walk Again Project at Wrocław Medical University does not appear to be actively enrolling participants at this time.

United Kingdom (Ongoing Research):

The Nicholls Spinal Injury Foundation continues to support complementary research into olfactory ensheathing cells (OECs). A new clinical trial in the UK is reportedly in preparation, though with a slightly modified protocol—potentially drawing on a different source of olfactory cells and applying revised patient selection criteria. At present, no public information has been released, but this effort may be directed toward acute rather than chronic injuries.

Relevant preclinical work includes a 2019 study on OEC transplantation combined with biomaterials. The authors concluded that:

“Combining OECs with biomaterials such as collagen significantly increases transplant size without reducing the repair capacity of OECs. This enhances the feasibility of bridging larger spinal cord injury areas, such as human contusion lesions. Furthermore, elongation of OECs guided along nanofibers provides directional pathways, potentially improving regeneration of nerve fibers in spinal cord injury.”          

Latest Update (August 23, 2025):

Australia:

Griffith University and the Perry Cross Foundation (Queensland, Australia) have announced the launch of patient recruitment for their clinical trial of olfactory nerve bridge cell transplantation combined with intensive exercise therapy.

How this approach differs from earlier efforts in Poland and the UK:

• The therapy is still based on OECs, but the Australian team uses cells collected from a minimally invasive nasal biopsy (rather than removing tissue from the olfactory bulb deep in the brain).

• The cells are then purified, engineered, and formed into 3D cellular nerve bridges, which neurosurgeons can implant directly into the injured spinal cord.

• This configuration is expected to enhance survival of transplanted cells and leverage OECs’ regenerative potential more effectively.

According to the foundation: “This Spinal Injury Project is reinventing and rethinking how cells can grow, leading to the creation of new cell products. By combining advanced cell purification and engineering techniques, the team has designed 3D nerve bridges that can be accurately implanted into the lesion site.”

A  short explanatory video is available on the foundation’s website.

Patient Enrollment – Clinical trial (Australia – Update August 23, 2025)

The trial at Griffith University (Gold Coast, Queensland) is now recruiting. Recruitment proceeds through an Expression of Interest (EOI) process, in which potential participants complete an eligibility questionnaire, here.

Trial design:

• Control group: intensive, long-term rehabilitation only.

• Active group: intensive, long-term rehabilitation plus olfactory cell nerve bridge transplantation.

Eligibility (summary):

• Complete (ASIA A) or incomplete (ASIA B or C) injuries.

• Cervical injuries (C5–C8) or thoracic injuries (T1–T12).

• Patients must have completed their initial physical rehabilitation.

Additional inclusion/exclusion criteria, along with FAQs, are available on the foundation’s project page. The trial does not yet appear on ClinicalTrials.gov.

Background Information (updated August 26, 2025):

In February 2019, Japan’s Ministry of Health approved the clinical use of induced pluripotent stem cells (iPS cells). These are cells created by reprogramming mature body cells back into an embryonic-like state, allowing them to differentiate into various cell types such as nerve cells. IPS cells demonstrate regenerative potential comparable to embryonic stem cells but avoid ethical controversies as no embryos are used.

This ongoing human trial follows successful experimental transplants in monkeys by Professor Hideyuki Okano and colleagues at Keio University, which enabled motor function restoration and walking ability. A scientific publication from September 2021 provided initial details about the upcoming human trial. The first patient surgery was reported in January 2022, and since then, three more patients have undergone the experimental treatment.

Regarding the mechanism of action, Dr. Okano explains:

“When we talk about ‘regeneration,’ we mean making something occur again. By transplanting neural stem cells into the spinal cord, developmental processes involving neurons, astrocytes, and oligodendrocytes can be repeated. This allows us to reestablish interrupted neuronal circuits, supplement axons with glial cells, restore myelin sheaths, repair damaged tissue structure, and restore functionality.”

The team is also developing a variant of iPS cells intended for treating chronic spinal cord injuries. A Dec. 1st, 2022 publication  details this mechanism and conditions under which such transplants may benefit chronic injuries, particularly when combined with other therapies.

Latest Update (August 26, 2025):

A Nature (March 2025) article reports that four patients have received the iPS experimental treatment, with two demonstrating significant functional improvement. The remaining two have shown little progress. All procedures occurred between two to four weeks post-injury (subacute phase), a period that can involve spontaneous recovery. This natural healing complicates attributing improvements solely to the treatment.

Patient Enrollment / Clinical Trials (August 26, 2025 update):

It remains uncertain whether additional patients will be enrolled in this trial or if new trials will be launched. Furthermore, it is not yet clear whether this iPS therapy will be applicable to chronic spinal cord injuries.

Background info (update August 26th, 2025):

Neuroplast is an independent company founded in 2013 and 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/. A Phase I trial has shown the treatment to be safe. The therapy involves the transplantation of Neurocells and would take place in two different centers: Toledo (Spain) and Copenhagen (Denmark). The Neurocells are expected to have positive effects both in terms of neuroprotection and neuroplasticity and thus contribute to a level of functional return in both chronic and acute spinal cord injury. So far, the human trial has taken place only in Spain.

Latest update (August 26th, 2025):

We contacted Neuroplast to obtain an update and are awaiting their reply. No further information has been published recently regarding the efficacy results of the treatment tested in the recent clinical trial in Spain.

Phase II/III (efficacy) trial: In September 2023, the company reported that 16 patients had been treated and that the first trial results would be available in February 2024, with full study completion expected by 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 initially received placebo but have been or will be treated with Neuro-Cells® after the initial six-month follow-up period. »

Patient enrolment/clinical trials (August 26th, 2025):

The Phase II trial (aiming to check efficacy), involving individuals with traumatic acute/sub-acute spinal cord injury (6–8 weeks after lesion) remains active but is no longer recruiting in Spain. It is unclear if patients will be recruited in Denmark. More information can be found here: NCT03935724.

Chronic SCI:
It is noteworthy that the ongoing trial recruiting patients in their sub-acute phase (6–8 weeks after SCI) will also test the therapy’s effect during the chronic phase. The protocol’s « early and late intervention cross-over design » assigns control-group patients to receive placebo at the sub-acute stage but then offers the stem-cell treatment six months after injury. Thus, although chronic SCI patients cannot enroll initially, the trial will nevertheless assess therapy effects at the chronic stage.

Background information (August 2025)

A clinical trial was launched in the USA in October 2014, sponsored by the biotech company Neuralstem, to evaluate the safety of their neural stem cells (NSI-566) in patients with chronic spinal cord injury. Four patients were treated. By October 2015, it was reported that the stem cell implantation had been safe and well-tolerated.

Since then, however, Neuralstem has effectively disappeared as a company pursuing therapies for spinal cord injury or ALS. First, it changed its name to Seneca Biopharma, marking a clear shift in focus. Later, following a merger, it became Palisade Bio and is now focusing exclusively on gastrointestinal therapies. As a result, there is nothing left of the original effort to advance research into therapies or cures for SCI and ALS. Unfortunately, this serves as another (sad) example of how market forces often do not align with the needs of patients, and how patient priorities may diverge from those of researchers and investors.

Latest update (August 27th, 2025)

The four patients who received neural stem cell transplants in 2014 have been followed closely by Dr. Ciacci in San Diego. They were the subject of a scientific report published in Cell Reports Medicine in December 2024, which described the long-term safety and clinical outcomes of the trial.

The publication confirmed that all four subjects tolerated the stem cell implantation procedure well. Two of the patients showed durable, electromyography-quantifiable evidence of neurological improvement, along with increased motor and sensory scores five years after transplantation. Importantly, all four patients originally had chronic (1–2 years post-injury), complete thoracic spinal cord injuries at the time of treatment.

Patient enrolment/ clinical trials (update August 2025)

The trial is still listed as recruiting patients on the ClinicalTrials.gov website. However, continuation appears unlikely since the sponsoring biotech company has long disappeared.

Background information (update August 2025):

In the fall of 2014, Dr. Wise Young (Rutgers University and SCINetChina) presented preliminary findings from the Umbilical Cord Blood (UCB) & Lithium Phase II clinical trial conducted in China. He explained that although none of the chronic ASIA A participants showed improved motor scores, 15 out of the 20 patients were able to take steps with the aid of a walker during rehabilitation.

You can view part of Dr. Young’s 2014 presentation at the Working2Walk symposium here.

The study has since been published in the open-access journal Cell Transplantation. See the publication abstract here.

Many questions remain regarding the extent of the reported “functional” recovery. For example: is the observed walking functional if patients’ motor scores did not improve—meaning they could not willfully contract any muscles? In addition, the source of reported improvements remains unclear. Because the treatment combined stem cell transplantation with intensive physiotherapy, it is difficult to identify which of the two (or both) primarily contributed to the changes.

Latest update (August 27th, 2025):

• April 2025: We reached out to a member of Dr. Wise Young’s team for an update but have not yet received feedback.
  The most recent information dates back to a November 2024 Zoom call, during which Dr. Wise Young explained the current status of his research. He mentioned that the upcoming trial might instead take place in Hong Kong, as it is easier to raise funds there. American patients wishing to participate would therefore need to travel to Hong Kong.

  Dr. Young also described recent research focusing on T12/lumbar spinal cord injury models. In such cases, the Central Pattern Generator (CPG) ceases to function, and his findings suggest that a combination therapy approach may be necessary.

• Earlier update (2023): Dr. Young was still actively raising funds to launch the U.S. trial and had expressed hope of starting in fall 2023.

  In a September 2021 presentation, he announced significant changes to the planned U.S. trial design: it would now include 40 participants and feature a control group (patients not receiving stem-cell treatment). Lithium would be removed from the protocol to simplify it. Instead, the trial would only involve UCB stem cells and/or intensive physiotherapy.

  The trial was initially expected to begin in January 2022. However, StemCyte—the company originally providing the stem cells—pulled out of the U.S. trial and launched their own trial in Taiwan. As a result, the team has had to seek a new cell source and restart the IND (Investigational New Drug) approval process from the beginning. The FDA is requiring additional safety and efficacy studies to validate any new stem cell sources.

Patient enrollment/ clinical trial (update August 27th, 2025):

• USA and/or Hong Kong:
  The study remains in preparation and is not currently recruiting patients.
  The previously announced inclusion criteria were:

  • Complete injury between C5 and T11

  • Injury duration greater than 1 year

  • Age between 18–64 years

  For more information, contact: sciproject@dls.rutgers.edu.

• StemCyte’s trial in Taiwan:
  The biotech company that had withdrawn from the U.S. clinical trial later launched its own study in Taiwan (NCT03979742). However, the company terminated the trial in February 2025 for strategic reasons.