Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
May be male or female
Must be between 18 years and 65 years of age
Must have a below the knee amputation.
Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.
Disqualifiers
A skin erosion deeper than the skin dermis.
Having received any investigational drug within 30 days prior to study entry
An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).
Pregnant, lactating, or trying to become pregnant
Trial design
Treatments tested in this trial
- Autologous Skin Fibroblasts
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Maryland Stem Cell Research Fund
Collaborator
United States Department of Defense
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov