Actively Recruiting
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
Led by Johns Hopkins University · Updated on 2025-06-11
50
Participants Needed
1
Research Sites
447 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
M
Maryland Stem Cell Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Between 18 years and 65 years of age
- Have a below the knee amputation
- Using a prosthetic for about 3 months or have had osteo-integration of a prosthetic for at least 1 month
- Medically able to undergo study procedures based on laboratory 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 not to become pregnant or breastfeed during the study and for 1 month after
- Females of childbearing potential must be willing to use reliable contraception during the study
- Willing and able to attend scheduled visits, biopsy/injection procedures, follow wound care instructions, and comply with study treatment plans for the duration of the study
You will not qualify if you...
- Skin erosion deeper than the dermis
- Received any investigational drug within 30 days prior to study entry
- Allergy to study materials including local anesthetic, dimethyl sulfoxide, human albumin, bovine constituents, hetastarch, or EMLA cream
- Pregnant, lactating, or trying to become pregnant
- History of keloid formation
- Significant medical history deemed unsafe by investigator, including autoimmune skin diseases like lupus, metastatic cancer, or infections such as HIV, HTLV I/II, Hepatitis B or C
- Presence of necrotic or ischemic tissue on stump ulcers or capillary refill time over 3 seconds on stump skin
- Active infection of the residual limb
- Active smoker during the study
- Use of chronic immunosuppressive therapies, including oral or topical steroids in the study area
- Recent amputee not yet approved to use a prosthetic
- Prosthetic use for less than 3 months
- Amputees with neuromas in the terminal limb within the last 3 months
- Known bleeding disorders
- History of serious allergy such as anaphylaxis to Bellafill/collagen skin test
- For whole stump injections: history of methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications linked to drug-induced methemoglobinemia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Dermatology at Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
R
Ruizhi Wang, MPhil
CONTACT
E
Erika Dare, CRNP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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