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Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

NCT03947450 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Amputation
  • Skin Wound
  • Stem Cell

Interventions

BIOLOGICAL

Autologous Skin Fibroblasts

The site or whole stump will be injected with autologous fibroblasts

BIOLOGICAL

Placebo

The site or whole stump will be injected medium only without autologous skin fibroblasts

Sponsors & Collaborators

  • Maryland Stem Cell Research Fund

    collaborator UNKNOWN

  • United States Department of Defense

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Luis Garza, MD PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2028-04-01
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947450 on ClinicalTrials.gov