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Cell Therapy

Schwann Cell Therapy for Peripheral Nerve Injury

Phase 1
Waitlist Available
Led By Allan Levi, MD, PhD
Research Sponsored by W. Dalton Dietrich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings
Between the ages of 18 and 65 years at last birthday
Must not have
Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether autologous human Schwann cells can improve nerve function in people with severe nerve damage.

Who is the study for?
This trial is for adults aged 18-65 who have had a severe peripheral nerve injury with a gap of 5-10 cm between healthy nerve endings within the last year. It's not suitable for those unable to undergo an MRI, with conditions affecting sural nerve harvest, gaps over 10 cm, local cancer history, pregnant women, or those with certain diseases or substance abuse.
What is being tested?
The study tests whether using one's own Schwann cells (ahSC) to repair damaged nerves can improve healing and function. Participants will receive ahSCs during surgery where their own nerves are used as grafts in areas like the sciatic nerve or brachial plexus.
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection and pain at the extraction site. There might also be immune reactions since cells are being transplanted, although this risk is reduced by using the patient’s own cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a nerve injury with a gap of 5 to 10 cm between ends.
Select...
I am between 18 and 65 years old.
Select...
I have had a severe nerve injury in my arm or leg within the last year.
Select...
I have had a severe nerve injury in my arm or leg within the last year.
Select...
I have a nerve injury with a gap of 5 to 10 cm between healthy ends.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had cancer or radiation in the area where I now have nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with reported adverse events (AEs)
Number of participants with reported cell product culture test failure
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
Secondary study objectives
Change in muscle strength scale grade of affected limb muscles
Change in pain characteristics (location, intensity, and description)
Change in pain scores
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous human Schwann cellsExperimental Treatment1 Intervention
All participants will receive autologous human Schwann cells harvested from their own sural nerve.

Find a Location

Who is running the clinical trial?

W. Dalton DietrichLead Sponsor
6 Previous Clinical Trials
47 Total Patients Enrolled
The Miami Project to Cure ParalysisOTHER
5 Previous Clinical Trials
25 Total Patients Enrolled
Allan Levi, MD, PhDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Autologous Human Schwann Cells (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03999424 — Phase 1
Peripheral Nerve Injury Research Study Groups: Autologous human Schwann cells
Peripheral Nerve Injury Clinical Trial 2023: Autologous Human Schwann Cells Highlights & Side Effects. Trial Name: NCT03999424 — Phase 1
Autologous Human Schwann Cells (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999424 — Phase 1
Peripheral Nerve Injury Patient Testimony for trial: Trial Name: NCT03999424 — Phase 1
~1 spots leftby Sep 2025
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