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NCT04839497
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
Phase 2 trial testing Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees in Amputation in 20 participants. Currently enrolling.
1 August 2026
Quick facts
| Lead sponsor | Major Extremity Trauma Research Consortium |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 26 September 2022 |
| Primary completion | 1 August 2026 |
| Estimated completion | 1 January 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees
Conditions studied
- Amputation — all drugs for Amputation →
Sponsor
Major Extremity Trauma Research Consortium
Who can join
Adults 18 to 75, any sex, with Amputation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04839497
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Other Major Extremity Trauma Research Consortium trials
Trials by the same sponsor.
- NCT06337292 — Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures · Phase 3 · recruiting
- NCT05889559 — Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Sy · NA · recruiting
- NCT04789044 — Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion) · Phase 2 · recruiting
- NCT05143476 — Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion · completed
- NCT04597008 — Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04839497 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Major Extremity Trauma Research Consortium
- Last refreshed: 14 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04839497.
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