Health TrialsbyHealthPanel

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

ConditionsAmputationSkin WoundStem Cell
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Autologous Skin Fibroblasts

    Biological/Vaccine

    The site or whole stump will be injected with autologous fibroblasts

  • Placebo

    Biological/Vaccine

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Autologous skin fibroblastsExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety as assessed by number of hospitalizations

To determine the safety of the use of autologous volar fibroblasts to reprogram non-volar to volar-like epidermis with larger cytoplasmic area in human participants. The investigators will measure the numbers of hospitalizations which are related to the study. The occurrence of any study related hospitalization will be counted as one.

Time frame
12 months

Secondary outcomes

1

Change in amount of skin breakdown as assessed by ulceration measurement

Skin breakdown as assessed by ulceration measurement: The investigators will measure areas of skin breakdown on the terminal limb to see if the areas injected with volar fibroblasts have influenced skin healing. The unit of measurement is in millimeters. Pre and post cell-injection measurements will be compared.

Time frame
Baseline, 1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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