Actively Recruiting
Feasibility Study for Fibroblast Autologous Skin Grafts
Led by Johns Hopkins University · Updated on 2025-11-10
80
Participants Needed
1
Research Sites
721 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study for Fibroblast Autologous Skin Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- May be male or female
- Must be between 18 years and 65 years of age
- Medically able to receive study treatment with no clinically significant abnormalities based on lab tests within 7 days before baseline
- Able to understand and provide informed consent
- Females of childbearing potential must have a negative pregnancy test at screening
- Females of childbearing potential must agree to avoid pregnancy and breastfeeding during the study and for 1 month after
- Females of childbearing potential must be willing to use reliable contraception during the study
- Have healthy skin as determined by the principal investigator or study nurse practitioner
- Willing and able to follow scheduled visits, biopsy and injection procedures, wound care, treatment plan, and other study activities
You will not qualify if you...
- Received any investigational drug within 30 days before study entry
- Allergic history to study materials including local anesthetic, dimethyl sulfoxide, human albumin, bovine constituents, or hetastarch
- Pregnant, lactating, or trying to become pregnant
- History of keloid formation
- Active nonhealing wound
- Significant medical history deemed unsafe by the investigator, including autoimmune conditions, metastatic cancer, or infections like HIV, HTLV I/II, Hepatitis B, or Hepatitis C
- Autoimmune skin diseases such as lupus
- Current skin diseases like extreme and active eczema, psoriasis, or lichen planus deemed unsafe by the investigator
- Diagnosis of uncontrolled diabetes
- Active smoker during the study
- On chronic immunosuppressive treatments such as oral or topical steroids in the study area
- Known bovine or meat sensitivity or severe allergies causing anaphylaxis to any product
- Known bleeding disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins School of Medicine, Dermatology Department
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
R
Ruizhi Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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