Trial studying safety and effects for Peripheral Nerve Injury
Official title Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
ClinicalTrials.gov ID: NCT05541250
What this study is testing
What is Autologous Human Schwann Cell?
This is an investigational biological treatment being studied for peripheral nerve injury. It is designed to support nerve repair by using cells that naturally help nerves grow and heal.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding your own Schwann cells to a nerve graft is safe and how it might affect healing.
- Who it's for
- You may be able to join if you have a severe injury to a major nerve and are willing to try a new treatment.
- What's involved
- You will receive an injection of your own Schwann cells with a nerve graft. You will have visits for the injection and follow‑up check‑ins.
- Time commitment
- The study lasts about a few months, with several clinic visits for the injection and later follow‑up appointments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
- Between the ages of 18 and 65 at last birthday
You likely can't join if
- Persons unable to safely undergo an MRI;
- Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
- Persons with severe peripheral nerve injury gap length \> 10 cm;
- Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
- Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
- Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
See the full eligibility criteria
- Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
- Between the ages of 18 and 65 at last birthday
- Persons unable to safely undergo an MRI;
- Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
- Persons with severe peripheral nerve injury gap length \> 10 cm;
- Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
- Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
- Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
- History of active substance abuse;
- Persons allergic to gentamicin;
- Persons who test positive for HIV or Hepatitis B or C virus.
- Persons unable to provide consent independently due to cognitive impairment
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.