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Autologous Volar Fibroblast Injection for Amputees

This study is testing a new approach for people with below-the-knee amputations. Researchers are looking at whether injecting your own skin cells (called autologous volar fibroblasts) from your palm or sole into your stump can make the skin thicker and firmer. This might help with skin irritation from prosthetic sockets. You could be eligible if you are between 18 and 65 years old, have a below-the-knee amputation, and have been using a prosthetic for at least 3 months or had an osteo-integrated prosthetic for 1 month. The main goal is to check the safety of these injections over 12 months. This study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This interventional study will involve 50 participants who will either receive injections of autologous skin fibroblasts or a placebo (medium only).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be assessed for 12 months after the injections.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03947450

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

Recruiting
PHASE2Ages 18–65InterventionalPrevention
Johns Hopkins University
~50 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Autologous Skin FibroblastsPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as assessed by number of hospitalizations
Measured over 12 months

Conditions

Amputation
Skin Wound
Stem Cell

Explore related trials

Amputation

NCT03947450

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Department of Dermatology at Johns Hopkins University

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Luis Garza, MD PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Ruizhi Wang, MPhil
[email protected]
410-502-7546
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.
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
Females of childbearing potential must:
have a negative pregnancy test at screening
agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
be willing to use a reliable form of contraception during the study
Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.

Exclusion

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
A history of keloid formation
Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I/II, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.
Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.
Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds
Active infection of the residual limb.
Active smoker during the study
We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.
Recent amputee who has not yet been approved to use a prosthetic.
Use of a prosthetic for less than 3 months.
Amputees with neuromas of the terminal limb within the last 3 months.
Known bleeding disorder.
For those receiving Bellafill/collagen skin test: history of serious allergy, such as anaphylaxis.
For whole stump injections: Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Para-aminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)

What this trial measures

  • Safety as assessed by number of hospitalizations12 months

    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.