Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

NCT ID: NCT03947450

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2028-04-01

Brief Summary

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.

Detailed Description

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.

The investigators have demonstrated that injection of fibroblasts (from the palm or sole) is safe in healthy adults and potentially enhances palm or sole features in skin cells in areas other than the palm and sole. In a prior study, healthy adults injected with fibroblasts (from the palm or sole) experienced more firm skin at the injection site.

The objective of this study is to determine if fibroblast (from palm or sole) injections are safe and effective at increasing epidermal thickness and skin firmness at the stump site in below the knee amputees. Outcomes are assessed via questionnaires, non-invasive imaging devices, and non-invasive skin firmness measuring devices.

Injections will be targeted to the entire stump (unless determined otherwise by the PI and participant), including pressure intolerant areas of the skin that come into contact with the prosthetic socket, a region that is prone to skin irritation and breakdown, We will evaluate the most effective approach to administering this intervention via injections to the entire stump and the safety and effectiveness of whole stump injections and their effects on prosthesis use, skin breakdown, quality of life, and activity level.

The investigators hope that information from this study will help with problems like skin breakdown in patients with amputations and prosthetics. The skin at the stump was not meant to withstand the pressure and friction of prosthetics and this study is the first step in trying to convert stump skin to palm/sole-like skin.

Conditions

Amputation; Skin Wound; Stem Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Autologous skin fibroblasts

For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections.

For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts.

Group Type: EXPERIMENTAL

Autologous Skin Fibroblasts

Intervention Type: BIOLOGICAL

The site or whole stump will be injected with autologous fibroblasts

Control

For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections.

For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

The site or whole stump will be injected medium only without autologous skin fibroblasts

Interventions

Autologous Skin Fibroblasts

The site or whole stump will be injected with autologous fibroblasts

Intervention Type: BIOLOGICAL

Placebo

The site or whole stump will be injected medium only without autologous skin fibroblasts

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maryland Stem Cell Research Fund

UNKNOWN

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Garza, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Department of Dermatology at Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ruizhi Wang, MPhil

Role: CONTACT

rwang53@jhmi.edu

410-502-7546

Erika Dare, CRNP

Role: CONTACT

edare1@jhmi.edu

410-502-7546

Facility Contacts

Ruizhi Wang

Role: primary

Rwang53@jhmi.edu

410-502-7546

Erika Dare, CRNP

Role: backup

edare1@jhmi.edu

410-502-7546

References

Tsai J, Rostom M, Garza LA. Understanding and Harnessing Epithelial-Mesenchymal Interactions in the Development of Palmoplantar Identity. J Invest Dermatol. 2022 Feb;142(2):282-284. doi: 10.1016/j.jid.2021.06.016. Epub 2021 Aug 6.

Reference Type: DERIVED

PMID: 34366107 (View on PubMed)

Other Identifiers

W81XWH-18-2-0055

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00192461

Identifier Type: -

Identifier Source: org_study_id