Fibroblast Injection for Amputee Limb Care

Overseen By Luis Garza, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Major Extremity Trauma Research Consortium

Must not be taking: Immunosuppressants, Steroids, Methemoglobinemia drugs

Disqualifiers: Pregnancy, Autoimmune conditions, Active smoker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment to improve skin firmness and thickness on the residual limbs of individuals with lower leg amputations. Participants will receive either injections of fibroblasts—special cells that can repair and strengthen skin—or a placebo, an inactive substance for comparison. The goal is to determine if fibroblast injections strengthen the skin without causing serious side effects. Ideal candidates for this trial are adults who have had a below-the-knee amputation and regularly use a prosthetic leg. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressive therapies or certain medications associated with methemoglobinemia, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that injections using a person's own skin cells are generally safe. In studies involving individuals with below-knee amputations, these injections have been well-tolerated, with no serious health problems related to the treatment.

The procedure uses fibroblasts, cells that help build connective tissue. These cells are taken from the person's own palm or sole, reducing the likelihood of a negative reaction and lowering the risk of rejection.

The treatment aims to improve the thickness and firmness of the skin at the amputation site. So far, research suggests that the injections are safe, with no major side effects reported in early studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care options for amputee limb care, which often focus on prosthetics and pain management, autologous volar fibroblast injection offers a novel approach by directly targeting the residual limb's tissue health. This treatment is unique because it uses a patient's own volar fibroblasts, which are cells known for their potential to promote healing and tissue regeneration. Researchers are excited about this treatment because it could improve limb health at the cellular level, potentially reducing complications and enhancing comfort for amputees.

What evidence suggests that Autologous Volar Fibroblast Injection might be an effective treatment for amputee limb care?

Research has shown that injections using a person's own skin cells can improve skin strength and thickness in amputees. In this trial, participants may receive the Volar Fibroblast Treatment, which uses cells from the palm or sole to enhance the skin at the amputation site. Studies have found that this treatment makes the skin firmer and the outer layer thicker. The cells strengthen the skin at the stump site, making it tougher and more resilient. This treatment is considered safe and may help people with amputations by fortifying the skin on their remaining limbs. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-75 with a below-the-knee amputation who use a prosthetic leg can join this trial. They must have healthy skin on the limb, not be pregnant or breastfeeding, and agree to contraception during the study. Smokers, those with certain skin diseases, active infections, bleeding disorders or taking immunosuppressants are excluded.

Inclusion Criteria

My skin is healthy and I don't have severe skin conditions or non-healing wounds.

Able to provide written informed consent

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

Pregnant, lactating, or trying to become pregnant

I have a known bleeding disorder.

I have ulcers larger than 4cm across.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy and Preparation

Participants undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb

1 week

Treatment

Participants receive low-dose volar fibroblast injections or vehicle control injections over the course of one week

1 week

1-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical evaluations and non-invasive assessments

3 months

4 visits (in-person) at 2 weeks, 1, 2, and 3 months

Open-label Extension

Participants in the vehicle control group have the opportunity to receive volar fibroblast injections and are followed for an additional 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Volar Fibroblast Injection

Trial Overview The trial is testing injections of volar fibroblasts (cells from one's own body) into the residual limbs of amputees to see if it makes their skin firmer compared to a control group receiving a placebo. Participants will be followed for up to three months after treatment.

How Is the Trial Designed?

Group I: Volar Fibroblast Treatment Experimental Treatment 1 Intervention

Volar fibroblasts are injected into the residual limb of transtibial amputees

Group II: Cryoprotectant Active Control 1 Intervention

Vehicle Control. Interdermal injection of cryoprotectant

Autologous Volar Fibroblast Injection is already approved in United States for the following indications:

Approved in United States as Autologous Volar Fibroblast Injection for:

• Thickening the epidermal layer at the stump site in individuals with below the knee amputations

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials

32

Recruited

27,400+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Autologous cultured fibroblasts can be injected to help repair acne scars and other facial imperfections, utilizing the patient's own cells for a more natural healing process.

This method offers a gradual correction of contour deformities, potentially leading to more effective and personalized treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous cultured fibroblasts as cellular therapy in plastic surgery. Boss, WK., Usal, H., Chernoff, G., et al.[2022]

The study evaluated the safety and effectiveness of combined scar treatments using autologous derived agents like platelet-rich plasma (PRP) and lipofilling, alongside medical devices such as radiofrequency and CO2 laser, in three cases.

No adverse events were reported, and all cases showed improvement in scar quality and function, indicating that these combined methods are safe and enhance both cosmetic and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined therapies in scar treatment-The role of autologous derived agents in scar remodeling: A series of cases. Surowiecka, A.[2022]

Autologous fat transplantation, or lipofilling, is an effective technique for correcting skin abnormalities by transferring fat from one area of the body to another, allowing for long-term improvements in skin texture.

The procedure is minimally invasive, performed on an outpatient basis under local anesthesia, and can effectively treat areas of dermal or hypodermal atrophy ranging from one to a few centimeters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autologous fat transplantation in dermatology]. Skaria, AM., Pham, C., Braun, R., et al.[2006]

Cultured autologous fibroblasts (Isolagen) have been effectively used in 1,450 patients to treat various skin issues, showing a high patient satisfaction rate of 92% regarding the correction of skin conditions after treatment.

Long-term follow-up (36 to 48 months) indicated that 70% of patients experienced continued improvement beyond the initial results, suggesting that this injectable system not only provides immediate correction but also promotes ongoing skin repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous cultured fibroblasts: a protein repair system. Boss, WK., Usal, H., Fodor, PB., et al.[2022]

Autologous fat graft injections showed some benefits for patients with painful scars and pulp atrophy following digital trauma, with a mean satisfaction score of 3.36 out of 5 regarding symptom and aesthetic improvement.

The procedure had limited impact on neuropathic pain, as indicated by the average visual analogue scale pain score of 2.91 out of 10, suggesting that while fat grafting can help with certain physical issues, it may not effectively address nerve-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Autologous Fat Graft Injection(s) in Treating Sequelae of Digital Trauma: A Case Series. Lupon, E., Paoli, H., Villeneuve Bargemon, JB., et al.[2023]

In a study involving 11 patients with persistent incisional pain, autologous fat injections led to a significant reduction in pain, with a mean decrease of 3.5 points on the Visual Analog Scale (VAS).

The treatment was well-received, with 74.5% of patients reporting satisfaction and no complications observed, indicating that autologous fat grafting is a safe and effective option for managing painful scars resistant to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autologous fat grafting in the surgical management of painful scar: preliminary results]. Baptista, C., Iniesta, A., Nguyen, P., et al.[2022]

In a study involving five diabetic patients with long-standing skin ulcers, autologous skin cell implants (fibroblasts and keratinocytes) led to complete healing in 83.3% of ulcers within 21 to 120 days, demonstrating significant efficacy for difficult-to-heal diabetic ulcers.

The treatment was safe, with no adverse reactions reported, and it is a minimally invasive procedure that can be performed in an outpatient setting, making it a promising option for patients unresponsive to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue therapy with autologous dermal and epidermal culture cells for diabetic foot ulcers. Marcelo, D., Beatriz, PM., Jussara, R., et al.[2018]

Autologous fibroblast transplantation is a safe and effective method for improving atrophic scars caused by cutaneous leishmaniasis, with no observed side effects in the study.

The treatment led to significant improvements in epidermal thickness, melanin levels, and skin elasticity after two injections, although dermal thickness did not show improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fibroblast transplantation in the healing of cutaneous leishmaniasis scar: A case report. Faghihi, F., Larijani, G., Mohebbi, L., et al.[2023]

In a study involving 60 Thai women with moderate to severe nasolabial folds, autologous cultured fibroblast injections showed significant improvement in NLF volume at all follow-up points compared to baseline, indicating their effectiveness as a treatment option.

The autologous fibroblast group reported more noticeable improvements in NLFs than the hyaluronic acid filler group, with no serious adverse reactions observed, suggesting that fibroblast injections are a safe alternative with potentially longer-lasting results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds. Wanitphakdeedecha, R., Ng, JNC., Phumariyapong, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03947450

Autologous Volar Fibroblast Injection Into the Stump Site of ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11457755/

The use of ectopic volar fibroblasts to modify skin identity These features included increased skin firmness, greater epidermal thickness, larger keratinocyte size, longer dermal collagen fiber length, ...

3. policylab.us policylab.us/clinical-trials/l/conditions/amputation?page=3

Amputation Clinical Trials - Policy Lab Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. NCT04839497. Recruiting. The ...

4. kalhorlab.bme.jhu.edu kalhorlab.bme.jhu.edu/wp-content/uploads/2024/09/2024_Lee-et-al._Science_The-use-of-ectopic-volar-fibroblasts-to-modify-skin-identity.pdf

The use of ectopic volar fibroblasts to modify skin identity Modifying skin identity has clinical potential, such as the conversion of residual limb and stump. (nonvolar) skin of amputees to pressure- ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT04839497/ICF_000.pdf

RESEARCH PARTICIPANT INFORMED CONSENT AND ... The goal of this study is to see if volar fibroblast injections are safe in adults with a below the knee amputation. The skin at the end of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11928270/

Volar Fibroblasts and their Potential Therapeutic Use - PMC The hypothesis of utilizing autologous transplantation of volar fibroblasts into the nonvolar skin to enhance load tolerance on the stump site ...

7. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT04839497?keyword=%22Amputation%22

Multicenter Trial Evaluating the Safety and Efficacy of ... The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users.