Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03947450
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amputation
  • Skin Wound
  • Stem Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Autologous Skin Fibroblasts — BIOLOGICAL
    The site or whole stump will be injected with autologous fibroblasts
  • Placebo — BIOLOGICAL
    The site or whole stump will be injected medium only without autologous skin fibroblasts

Study Details

This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.

Key Dates

Start date
Sep 5, 2019
Status verified
Jun 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Autologous skin fibroblasts
    For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts.
  • Placebo Comparator: Control
    For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo.

Primary Outcome Measure

Safety as assessed by number of hospitalizations [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Dermatology at Johns Hopkins UniversityBaltimoreMaryland21287
Ruizhi Wang
[email protected]
410-502-7546
Erika Dare, CRNP
[email protected]
410-502-7546

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By research site
Department of Dermatology at Johns Hopkins University· Baltimore, MD

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