Understanding and Harnessing Epithelial‒Mesenchymal Interactions in the Development of Palmoplantar Identity.
Jerry Tsai, Mary Rostom, Luis A Garza
https://pubmed.ncbi.nlm.nih.gov/34366107Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID03947450
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees to Assess Safety and Efficacy
Led by Johns Hopkins University · Updated on 2025-06-11
50
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of injections using skin cells called volar fibroblasts, taken from the palm or sole, to thicken the skin layer at the stump site in people with below the knee amputations. This clinical trial focuses on adults and aims to improve skin firmness and thickness where the prosthetic contacts the stump, an area prone to irritation and skin breakdown. The study is conducted at Johns Hopkins University and builds on earlier findings showing fibroblast injections can firm skin in healthy adults. The study involves two groups: one receiving autologous skin fibroblast injections (from the participant's own palm or sole skin) and the other receiving placebo injections without fibroblasts. Injections may cover the entire stump or localized areas depending on the group and investigator decision. The trial compares effects on skin thickness, firmness, skin breakdown, prosthetic use, quality of life, and activity levels over time. Participants will be involved in scheduled visits for injections, skin assessments using non-invasive imaging and firmness devices, and questionnaires. Safety is monitored by tracking hospitalizations for 12 months, while skin breakdown is measured by ulceration at baseline and 1 month. The study includes follow-up to evaluate skin changes and the impact on prosthesis use, lasting up to several months.
CONDITIONS
Brief Title
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
Who Can Participate
Age: 18Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female adults between 18 and 65 years old
- Have a below the knee amputation
- Using a prosthetic limb for around 3 months or have had an osteointegrated prosthetic for 1 month
- Medically able to undergo study injections based on recent lab tests
- Able to understand and provide informed consent
- Females of childbearing potential must have a negative pregnancy test at screening, agree not to become pregnant or breastfeed during the study and for 1 month after, and use reliable contraception
- Willing and able to follow scheduled visits, biopsy/injection procedures, wound care, and other study requirements
You will not qualify if you...
- Skin erosion deeper than the dermis
- Received any investigational drug within 30 days before study entry
- Allergy to study materials including local anesthetics or components like dimethyl sulfoxide, human albumin, bovine constituents, or EMLA
- Pregnant, lactating, or trying to become pregnant
- History of keloid formation
- Significant medical history deemed unsafe by investigator, including autoimmune skin diseases such as lupus, metastatic cancer, or certain infections (HIV, HTLV I/II, Hepatitis B or C)
- Necrotic or ischemic tissue on stump ulcers or capillary refill time over 3 seconds
- 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 amputees not yet approved for prosthetic use
- Prosthetic use less than 3 months
- Neuromas of 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 congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications linked to drug-induced methemoglobinemia
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months
Participants receive injections of autologous skin fibroblasts or placebo into the stump site to assess safety and efficacy in skin thickening and firmness.
Multiple visits for injections and assessments during treatment period
Follow-up
Duration - Up to 12 months after last injection
Participants are monitored for safety and changes in skin condition after treatment ends.
Visits at baseline and 1 month post-injection for skin breakdown assessment
Trial Site Locations
Total: 1 location
1
Department of Dermatology at Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
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Research Team
R
Ruizhi Wang, MPhil
E
Erika Dare, CRNP
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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