Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

NCT03947450 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB00192461W81XWH-18-2-0055
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Skin Wound; Stem Cell

Keywords

amputation; stem cells; autologous fibroblast; skin wound; skin breakdown

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by number of hospitalizations

  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.

  12 months

Secondary Outcomes (1)

• Change in amount of skin breakdown as assessed by ulceration measurement

  Baseline, 1 month

Study Arms (2)

Autologous skin fibroblasts

EXPERIMENTAL

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.

Biological: Autologous Skin Fibroblasts

Control

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

Autologous Skin Fibroblasts BIOLOGICAL

The site or whole stump will be injected with autologous fibroblasts

Autologous skin fibroblasts

Placebo BIOLOGICAL

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Maryland Stem Cell Research Fund: collaborator
• United States Department of Defense: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Department of Dermatology at Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34366107 DERIVED

Study Officials

• Luis Garza, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruizhi Wang, MPhil

CONTACT

410-502-7546; rwang53@jhmi.edu

Erika Dare, CRNP

CONTACT

410-502-7546; edare1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In whole stump injection subjects: Subjects will be blinded to which injections they will receive. At the end of the study, subjects who received vehicle injections will be notified and offered whole stump volar fibroblast injections. Blinding will occur for outcomes assessor during measurements of epidermal thickness/area. In localized injection subjects: Sites were labeled as A and B, and mask for outcome assessors and subjects. All these are in the same subject.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm crossover, subjects will be randomized 1:1 into whole stump injections of volar fibroblasts and vehicle injections respectively. Subjects will be blinded to which injections they will receive. At the end of the study, subjects who received vehicle injections will be notified and offered whole stump volar fibroblast injections. Blinding will occur for research staff both during measurements of epidermal thickness/area. If the PI or subject determines that they do not qualify for whole stump injection, do not desire whole stump injection, or are already enrolled as localized stump injections- the study will continue as a parallel interventional study model in which 2 locations are selected for fibroblast and vehicle injections on the same subject. Subjects who receive localized injections will be offered whole stump fibroblast injection at the end of the study.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: September 5, 2019
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)