NCT03999424

Autologous Human Schwann Cells in Peripheral Nerve Repair

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: W. Dalton Dietrich · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Nerve Injuries

Interventions

Type	Name	Description
BIOLOGICAL	autologous human Schwann cells	Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix

Timeline

• Start date: 2019-09-24
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2019-06-26
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study