Health TrialsbyHealthPanel

Feasibility Study for Fibroblast Autologous Skin Grafts

ConditionWounds and Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University

About this trial

This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

May be male or female

Must be between 18 years and 65 years of age

In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.

Be able to comprehend the informed consent document and provide consent for participation

Disqualifiers

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, or hetastarch

Pregnant, lactating, or trying to become pregnant

A history of keloid formation

Trial design

Design model

Single group

Treatments tested in this trial

  • autologous skin fibroblasts

    Biological/Vaccine

    autologous skin fibroblasts

  • Filler Product

    Biological/Vaccine

    In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: autologous skin fibroblastsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cytoplasmic size increase

Volar keratinocytes have larger area of the cytoplasm. We will quantitate the area of cytoplasm of non-volar keratinocytes to see if they increase selectively with volar fibroblasts as opposed to other fibroblasts injections or vehicle. The change in the area of cytoplasm of non-volar keratinocytes will be measured. The units of this measurement are a ratio of cytoplasmic area to total cellular area as a control.

Time frame
6 months

Secondary outcomes

1

Durometer reading

Durometers measure the firmness of the skin. We will measure all sites to see if the area injected with volar fibroblasts is more firm. The units of measurement is in Durometer Units.

Time frame
6 months

Other outcomes

Sponsors and contacts

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

Johns Hopkins University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

United States Department of Defense

Collaborator

Maryland Stem Cell Research Fund

Collaborator

Source ClinicalTrials.gov
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