Autologous Schwann Cell Therapy for Peripheral Nerve Injury

Overseen By George Jimsheleishvilli, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: W. Dalton Dietrich

Disqualifiers: Pregnancy, Substance abuse, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-biopsy and transplant period

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for individuals with serious injuries to major nerves, such as the sciatic nerve. Researchers aim to determine if a person's own Schwann cells (a type of nerve-supporting cell) can safely aid in repairing these injuries. Participants will receive transplants of these cells to help heal the damaged nerve. Individuals who have experienced a major nerve injury in the arm or leg within the past year may qualify for this trial. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Autologous Human Schwann Cell therapy is likely to be safe for humans?

Research has shown that using a person's own Schwann cells (ahSC therapy) is generally safe. In one study, participants received these cell transplants, and the results indicated that the treatment was well-tolerated, with no major safety issues reported. Another study examined the use of these cells for nerve repair, and the findings confirmed their safety and practicality. Participants in these studies underwent procedures without significant side effects, suggesting that ahSC therapy is a promising and safe option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for peripheral nerve injuries, which often involve surgical repair or nerve grafting, Autologous Human Schwann Cell (ahSC) therapy utilizes the patient's own Schwann cells to promote nerve regeneration. This therapy involves a unique mechanism where cells are harvested from a sural nerve biopsy, then expanded and transplanted back into the injury site. Researchers are excited because this method has the potential to enhance natural healing processes and improve outcomes by directly targeting the damaged nerve cells, offering a more personalized and potentially effective approach to treatment.

What evidence suggests that Autologous Human Schwann Cell therapy might be an effective treatment for peripheral nerve injury?

Research has shown that using a person's own Schwann cells for nerve repair holds promise. In this trial, participants will receive an autologous human Schwann cell (ahSC) transplant. Studies have found these cells effective for individuals with peripheral nerve injuries. They aid in repairing and supporting nerve fibers after significant damage by promoting nerve cell regrowth and enhancing nerve function. Early results suggest this method could accelerate recovery and lead to better outcomes for those with major nerve injuries. ^{2 3 5 6 7}

Who Is on the Research Team?

W. Dalton Dietrich, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have had a severe nerve injury in the past year, such as sciatic or brachial plexus injuries. It's not for pregnant women, those with certain pre-existing conditions, allergies to gentamicin, HIV/Hepatitis B/C, cognitive impairments that prevent consent, or if the nerve gap is over 10 cm.

Inclusion Criteria

I have had a major nerve injury in my arms or legs within the last year.

Exclusion Criteria

Persons allergic to gentamicin

I have had cancer or radiation treatment in the area where my nerve was injured.

Persons who test positive for HIV or Hepatitis B or C virus

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a sural nerve biopsy followed by autologous human Schwann cell (ahSC) transplant

Immediate post-biopsy and transplant period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sensory and motor recovery assessments

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Human Schwann Cell

Trial Overview The study tests injecting patients' own Schwann cells into their injured nerves alongside a standard nerve grafting procedure. The goal is to see if this approach improves recovery from severe peripheral nerve injuries.

How Is the Trial Designed?

Group I: Autologous Human Schwann Cell (ahSC) Group Experimental Treatment 1 Intervention

Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant

Autologous Human Schwann Cell is already approved in United States, China for the following indications:

Approved in United States as Autologous Human Schwann Cell for:

• Severe Peripheral Nerve Injury (PNI)
• Spinal Cord Injury (SCI)

Approved in China as Autologous Human Schwann Cell for:

• Spinal Cord Injury (SCI)

Who Is Running the Clinical Trial?

W. Dalton Dietrich

Lead Sponsor

Trials

7

Recruited

60+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Schwann cell transplantation, especially when combined with decellularized nerve scaffolds, has shown promising results in repairing peripheral nerve injuries, based on animal studies and recent human reports.

The review highlights the importance of the extracellular matrix and Schwann cell secretory products in promoting nerve repair, providing a solid foundation for clinical applications in treating peripheral nerve injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic strategies for peripheral nerve injury: decellularized nerve conduits and Schwann cell transplantation. Han, GH., Peng, J., Liu, P., et al.[2020]

Transplanted Schwann cells can effectively remyelinate central nervous system axons in rodent models, producing structurally normal myelin that restores nerve conduction, indicating their potential for repairing demyelinated lesions.

The ability to obtain large quantities of Schwann cells for autologous transplantation suggests a promising therapeutic approach for demyelinating diseases, but further research in non-human primate models is needed to understand the differences between species and optimize treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schwann cell transplantation and myelin repair of the CNS. Baron-Van Evercooren, A., Avellana-Adalid, V., Lachapelle, F., et al.[2017]

Human adipose-derived stromal cells (ADSCs) can be effectively induced to differentiate into mature Schwann cell-like cells using insulin, progesterone, and glucocorticoids, enhancing their functional characteristics for nerve regeneration.

These modified Schwann cell-like cells significantly improved axon regrowth, myelination, and functional recovery in a sciatic nerve injury model, indicating their potential as a therapeutic strategy for peripheral nerve injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiated human adipose-derived stromal cells exhibit the phenotypic and functional characteristics of mature Schwann cells through a modified approach. Kang, Y., Liu, Y., Liu, Z., et al.[2020]

Transplanting autologous activated Schwann cells (AASCs) in six patients with spinal cord injury (SCI) showed no severe adverse events, indicating the procedure is safe.

All patients demonstrated improvements in autonomic, motor, and sensory functions over more than 5 years of follow-up, suggesting that AASC transplantation is effective for promoting neurorestoration in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplantation of autologous activated Schwann cells in the treatment of spinal cord injury: six cases, more than five years of follow-up. Zhou, XH., Ning, GZ., Feng, SQ., et al.[2022]

Using human autologous serum instead of fetal bovine serum for cultivating human schwann cells significantly enhances the safety of clinical cell transplantation procedures, as demonstrated in a study involving 10 sural nerves from brain death donors.

The study achieved a high cell purity of 97% to 99% (mean 98.11%) without the use of growth factors, indicating that clinical-grade schwann cell cultivation is feasible and can meet safety standards for future applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical grade cultivation of human Schwann cell, by the using of human autologous serum instead of fetal bovine serum and without growth factors. Aghayan, HR., Arjmand, B., Norouzi-Javidan, A., et al.[2012]

Autologous adult human Schwann cells (SCs) show promise for spinal cord injury repair, with research over the past 40 years establishing their potential for clinical trials.

Studies in rat models have demonstrated that transplanted SCs can promote spinal cord repair, and preparations are underway for FDA-approved clinical trials to test this therapy in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From transplanting Schwann cells in experimental rat spinal cord injury to their transplantation into human injured spinal cord in clinical trials. Bunge, MB., Monje, PV., Khan, A., et al.[2018]

The study developed a rapid protocol for creating pure cultures of genetically modified adult human Schwann cells, which are crucial for repairing peripheral nerves.

Using an optimized electroporation method, nearly half (48.4%) of the Schwann cells were successfully transfected to produce proteins that promote nerve regeneration, indicating a promising approach for enhancing nerve repair strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous adult human Schwann cells genetically modified to provide alternative cellular transplants in peripheral nerve regeneration. Haastert, K., Mauritz, C., Matthies, C., et al.[2006]

Schwann cell cultures are a promising option for reconstructing large defects in peripheral nerves and spinal cord, highlighting their potential in tissue engineering.

Using Schwann cells from peripheral nerve autografts provides significant advantages for nervous system transplantation, while allogeneic Schwann cell transplantation can effectively repair peripheral nerve defects without delay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schwann cell cultures: recent advances and novel approaches to the reconstruction of peripheral nerve defects. Ştefănescu, O., Enescu, DM., Lascăr, I.[2012]

A Phase I clinical trial involving six paraplegic participants demonstrated that transplanting autologous human Schwann cells into the spinal cord injury site is safe, with no surgical or neurological complications observed one year post-transplantation.

The study confirmed the feasibility of harvesting Schwann cells from a peripheral nerve and transplanting them within 4-7 weeks of injury, indicating a potential therapeutic approach for enhancing recovery after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. Anderson, KD., Guest, JD., Dietrich, WD., et al.[2022]

A 1-year follow-up study of four patients with chronic spinal cord injury treated with autologous Schwann cell transplantation showed no adverse effects, indicating that the procedure is generally safe.

Only one patient experienced motor and sensory improvement after the transplantation, suggesting that while Schwann cell transplantation is safe, its efficacy in promoting recovery from spinal cord injury remains uncertain and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic thoracic spinal cord injury patients with autologous Schwann cell transplantation: an interim report on safety considerations and possible outcomes. Saberi, H., Moshayedi, P., Aghayan, HR., et al.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03999424

Autologous Human Schwann Cells in Peripheral Nerve ... The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39393574/

Schwann cell autotransplantation for the treatment of ... ... transplantation using autologous Schwann cells has shown good efficacy for patients with peripheral nerve injury. In recent years, Schwann ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0024320524007197

Schwann cell autotransplantation for the treatment of ... Transplantation using autologous Schwann cells has shown good efficacy for patients with peripheral nerve injury.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01739023

Safety of Autologous Human Schwann Cells (ahSC) in ... The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC) transplantation in subjects with subacute SCI.

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/partner/gnf/trial/360596

Safety and Efficacy of Autologous Human Schwann Cell ... The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28225648/

Safety of Autologous Human Schwann Cell ... A Phase I clinical trial was conducted to evaluate the safety of autologous human SC transplantation into the injury epicenter of six subjects with subacute ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9360180/

Phase 1 Safety Trial of Autologous Human Schwann Cell ... This phase 1 trial demonstrated the feasibility and safety of ahSC transplantation combined with a multi-modal rehabilitation protocol for participants with ...