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Study of Autologous Human Schwann Cells for Severe Nerve Injury

This study is looking at the safety of using your own Schwann cells (a type of nerve cell) to help repair severe peripheral nerve injuries (damage to nerves outside the brain and spinal cord). Researchers will take a small piece of nerve from your leg to get these cells, called Autologous Human Schwann Cell (ahSC), and then inject them along with a nerve graft. This study is open to people aged 18 to 65 who have experienced a severe sciatic nerve injury, brachial plexus injury, or other major nerve injury within the last year. The main goal is to see if there are any side effects from this treatment over a period of up to two years. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This interventional study plans to enroll 30 participants. It is designed to evaluate the safety and potential harms of the intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to monitor for treatment-related adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05541250

Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)

Recruiting
PHASE1Ages 18–65InterventionalSupportive care
W. Dalton Dietrich
~30 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Autologous Human Schwann Cell

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-related Adverse Events (AEs)
Measured over Up to 2 years

Conditions

Peripheral Nerve Injury

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Peripheral Nerve Injury

NCT05541250

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Miami

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • W. Dalton Dietrich, MD · STUDY_CHAIR · University of Miami

Who to contact

George Jimsheleishvilli, MD
[email protected]
(305) 2434781
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Incidence of Treatment-related Adverse Events (AEs)Up to 2 years

    Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician