Schwann Cell Therapy for Peripheral Nerve Injury

Recruiting in Palo Alto (17 mi)

Overseen ByAllan Levi, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: W. Dalton Dietrich

No Placebo Group

Trial Summary

What is the purpose of this trial?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 peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.

Eligibility Criteria

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.

Inclusion Criteria

I have a nerve injury with a gap of 5 to 10 cm between ends.

I am between 18 and 65 years old.

I have had a severe nerve injury in my arm or leg within the last year.

I have a nerve injury with a gap of 5 to 10 cm between healthy ends.

Exclusion Criteria

I have had cancer or radiation in the area where I now have nerve damage.

Participant Groups

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.

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.