Evaluating fibroblast injections for amputees

A Phase 2 Multicenter Randomized Single Arm Crossover Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees

This study is testing if injections made from patients' own skin cells can help improve the healing and comfort of adults with lower leg amputations using prostheses.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Major Extremity Trauma Research Consortium (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04839497 on ClinicalTrials.gov

What this trial studies

This clinical trial involves 20 adults aged 18-75 with transtibial amputations who are using prostheses. Participants will be randomly assigned to receive either low-dose autologous volar fibroblast injections or a vehicle control. The fibroblasts will be harvested from the participants' own skin and processed for injection. Participants will be monitored for safety and efficacy over a period of three months following the injections.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with transtibial amputations who are current users of prosthetic limbs.

Not a fit: Patients with severe skin diseases or those who are not medically cleared for the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance healing and functional outcomes for amputees.

How similar studies have performed: While similar approaches have been explored, this specific application of fibroblast injections in amputees is relatively novel.

Eligibility criteria

Inclusion criteria:

1. Ages 18 to 75, inclusive
2. Must have a transtibial amputation
3. Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month
4. In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no clinically significant abnormality.
5. Able to provide written informed consent
6. 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.
7. Has healthy skin on the residual limb and is free of severe and active skin disease (excluding those on the residual limb) such as extreme and active eczema or psoriasis, active non-healing wounds, lichen planus, a history of keloid scare formation or lupus as determined by the investigator or study nurse.
8. 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:

1. A skin erosion deeper than the skin dermis.
2. Ulcers exceeding 4cm in diameter or 2cm in radius
3. Non circular ulcers that cannot tolerate a 1cm margin at all sides
4. Having received any investigational drug within 30 days prior to study entry
5. 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%).
6. Pregnant, lactating, or trying to become pregnant
7. A history of keloid formation
8. 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).
9. Autoimmune diseases affecting the skin such as lupus.
10. Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds
11. Active infection of the residual limb (e.g. osteomyelitis, wound or skin condition with surrounding swelling, erythema, drainage, pain, gangrenous tissue or fever).
12. Active smoker during the study (this includes e cigarettes and any type of tobacco use)
13. 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.
14. Amputees with symptomatic neuromas of the terminal limb within the last 3 months.
15. Known bleeding disorder.
16. 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, Paraaminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)
17. Quadriplegics

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Dana Alkhoury

Conditions Amputation