Can palm skin cells toughen amputation stumps?
NCT ID NCT03947450
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting a person's own skin cells from the palm or sole into their amputation stump can thicken the skin and reduce breakdown. Researchers will enroll 50 adults with below-knee amputations who use a prosthetic. The goal is to see if this treatment is safe and helps prevent sores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous skin fibroblasts (the patient's own skin cells from palm or sole)
- What this could lead to
- If it works, this could offer a way to strengthen stump skin, reducing sores and improving prosthetic use for amputees.
- What could go wrong
- This is a small Phase 2 trial with only 50 participants, so results may not apply broadly. The treatment involves injections and carries risks like infection or no improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients interested in study participation must meet all of the following inclusion criteria: * 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 Criteria: Patients meeting any of the following criteria will be ineligible for study participation: * 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.)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Dermatology at Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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- Can Lab-Grown skin heal large wounds with better scars?
- Can we predict prosthetic success? a study seeks answers