Autologous Schwann Cell Therapy for Peripheral Nerve Injury

Overseen By George Jimsheleishvilli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: W. Dalton Dietrich

Disqualifiers: Pregnancy, Substance abuse, HIV, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.

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.

What data supports the effectiveness of the treatment Autologous Human Schwann Cell for peripheral nerve injury?

Research shows that Schwann cell transplantation can promote nerve regeneration and repair in both peripheral and central nervous systems. Studies have demonstrated improvements in motor and sensory functions in patients with spinal cord injuries after receiving autologous Schwann cell transplants, suggesting potential effectiveness for peripheral nerve injuries as well. ^{1 2 3 4 5}

Is autologous Schwann cell therapy safe for humans?

Research indicates that autologous Schwann cell therapy is generally safe for humans, as studies have shown no serious adverse effects or complications related to the therapy in patients with spinal cord injuries. Some patients experienced temporary sensations like tingling or muscle spasms, but no long-term safety issues were reported. ^{1 3 6 7 8}

How is Autologous Schwann Cell Therapy different from other treatments for peripheral nerve injury?

Autologous Schwann Cell Therapy is unique because it uses the patient's own Schwann cells, which are specialized cells that support nerve repair, to promote healing of peripheral nerve injuries. This approach is different from other treatments as it involves transplanting these cells directly to the injury site, potentially enhancing nerve regeneration and reducing the risk of immune rejection. ^{2 3 4 9 10}

Research Team

W. Dalton Dietrich, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

I am between 18 and 65 years old.

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

Trial Timeline

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

Treatment Details

Interventions

• Autologous Human Schwann Cell (Cell Therapy)

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.

Participant Groups

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 China for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Autologous adult human Schwann cells genetically modified to provide alternative cellular transplants in peripheral nerve regeneration. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Schwann cell transplantation and myelin repair of the CNS. [2017]

3. United States 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. [2022]

4. Romania pubmed.ncbi.nlm.nih.gov

Schwann cell cultures: recent advances and novel approaches to the reconstruction of peripheral nerve defects. [2012]

5. Netherlands 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. [2022]

7. Ireland 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. [2008]

8. Netherlands 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. [2012]

9. India pubmed.ncbi.nlm.nih.gov

Therapeutic strategies for peripheral nerve injury: decellularized nerve conduits and Schwann cell transplantation. [2020]

10. England 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. [2020]