Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Major Extremity Trauma Research Consortium
Study ID
NCT04839497
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees — COMBINATION_PRODUCT
    Autologous Volar Fibroblasts Treatment- harvested from patient's biopsied volar skin. Intradermal injection of Volar fibroblasts in the residual limb of transtibial amputees.

Study Details

The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2, and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months. The investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone.

Key Dates

Start date
Sep 26, 2022
Status verified
Oct 2025
Primary completion
Aug 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Volar Fibroblast Treatment
    Volar fibroblasts are injected into the residual limb of transtibial amputees
  • No Intervention: Cryoprotectant
    Vehicle Control. Interdermal injection of cryoprotectant

Primary Outcome Measure

Safety assessment of complications and adverse events associated with Volar Fibroblast injections [ Time Frame: 3 months from the injection visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Luis Garza, md
[email protected]

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By research site
Johns Hopkins Hospital· Baltimore, MD

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