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

Part of paid clinical trials in Miami, Florida.

Sponsor
W. Dalton Dietrich
Study ID
NCT05541250
Phase
PHASE1
Status
Recruiting
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Conditions

  • Peripheral Nerve Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Human Schwann Cell — BIOLOGICAL
    A one-time dose of 1000 μl\* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.

Study Details

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.

Key Dates

Start date
May 4, 2023
Status verified
Aug 2025
Primary completion
Sep 29, 2026
Completion
Sep 29, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Autologous Human Schwann Cell (ahSC) Group
    Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant

Primary Outcome Measure

Incidence of Treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
George Jimsheleishvilli, MD
[email protected]
(305) 2434781
Allan Levi, MD (PRINCIPAL_INVESTIGATOR)
S. Shelby Burks, MD (SUB_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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