Fibroblast Injection for Amputation Healing
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Johns Hopkins University
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Is fibroblast injection safe for humans?
Research shows that fibroblast injections, used for various skin conditions, have been generally safe in humans. Studies involving hundreds of patients reported no adverse reactions or tumor formation, indicating a good safety profile.
12367What data supports the effectiveness of the treatment Fibroblast Injection for Amputation Healing?
Research shows that using autologous fibroblasts (cells from a person's own skin) can help improve wound healing in various conditions, such as diabetic ulcers and skin scars, by enhancing skin thickness, elasticity, and healing rates. This suggests that fibroblast injections might also aid in healing after amputations.
13457Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those on chronic immunosuppressive therapies and certain other medications. It's best to discuss your specific medications with the trial team.
How is the treatment of autologous skin fibroblasts unique for amputation healing?
The treatment using autologous skin fibroblasts is unique because it involves injecting a patient's own skin cells to promote healing, which is different from traditional methods that might not use living cells. This approach has shown promise in improving skin elasticity and healing in other conditions, making it a novel option for amputation healing.
12457Eligibility Criteria
This trial is for adults aged 18-65 with below-knee amputations who use a prosthetic. Women must not be pregnant, breastfeeding, or planning to become pregnant and agree to contraception. Excluded are those with deep skin erosions, certain medical conditions (like autoimmune diseases), allergies to study materials, active infections, recent neuromas, or on immunosuppressives.Inclusion Criteria
I have had an amputation below the knee.
I am between 18 and 65 years old.
I am of childbearing age and my pregnancy test was negative.
I agree not to become pregnant or breastfeed during and for 1 month after the study.
Exclusion Criteria
I have dead tissue on my amputation site or slow blood return in the skin.
I am not on long-term immunosuppressive treatments, including oral or topical steroids.
I have a skin wound that is deeper than the outer layer of my skin.
I have a known bleeding disorder.
I have a history of severe allergies, like anaphylaxis.
I have an infection in the part of my body where a limb was amputated.
I have been using a prosthetic for less than 3 months.
I have a history of blood disorders or take medications that can affect my blood.
I do not have an autoimmune disease like lupus affecting my skin.
Participant Groups
The trial tests autologous volar fibroblast injections versus placebo in thickening the stump's skin layer for amputees. Participants will receive either their own cultured skin cells or a placebo injected into the stump site at Johns Hopkins.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Autologous skin fibroblastsExperimental Treatment1 Intervention
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.
Group II: ControlPlacebo Group1 Intervention
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Department of Dermatology at Johns Hopkins UniversityBaltimore, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
References
Autologous cultured fibroblasts: a protein repair system. [2022]Cultured autologous fibroblasts create a living injectable system that has been utilized effectively to treat rhytids, depressed scars, subcutaneous atrophy, acne irregularities, and laser wounds. Autologous cultured fibroblasts (Isolagen) as a protein repair system is produced from a 3-mm cutaneous punch biopsy. Skin biopsies are initiated in an in vitro tissue culture system. The cells are expanded to produce large quantities of fibroblasts and extracellular matrix totaling 1.0 to 1.5 ml. This cellular system is injected into the patient after 8 weeks of cellular expansion. Each area of treatment is injected once every 2 weeks for three injections. A total of 1,450 patients in the United States and Europe have been treated at designated centers. A total of 4,800 injections were given. At the University of Medicine and Dentistry of New Jersey and Hackensack University Medical Center, 94 patients were treated from 1995 through 1999. Long-term follow-up ranged from 36 to 48 months. A subjective patient satisfaction survey showed 92% of the patients were satisfied with the grade of correction. A long-term follow-up survey revealed continuing improvement beyond the initial correction in 70% of patients. Results from other designated centers correlated with the authors' findings. Cultured autologous fibroblasts (Isolagen) appears to be a living, cellular, dynamic filler system capable of immediate correction and continued repair of dermal and superficial subcutaneous deficiencies.
Safety of injectable autologous human fibroblasts. [2019]Autologous dermal fibroblasts after propagation in cell culture were used for face soft tissue augmentation. Twenty patients aged 37-61 years with facial rhytides and atrophic scars were treated with autologous fibroblasts from cell culture. Significant sustained clinical improvement was observed. Cells of early passages (4, 5, 6) were used for injection. The study showed that cultured fibroblasts were functionally active and produced large quantities of type I collagen. In vitro studies of scar formation potency of injectable fibroblasts showed that these cells possessed normal collagen gel contraction capacity. In vivo experiments showed that cultured fibroblasts exhibited no oncogenic properties and induced no tumors in nude mice.
Using hyaluronic acid derivatives and cultured autologous fibroblasts and keratinocytes in a lower limb wound in a patient with diabetes: a case report. [2004]Patients with diabetes have an impaired wound healing process that contributes to the pathophysiology that may lead to amputation. In this case study, an extensive (103.49 cm2) full-thickness cutaneous wound with exposure of a necrotic Achilles' tendon in a patient with diabetes, neuropathy, and infrapopliteal vascular disease of the lower limbs was healed using a two-stage autologous skin substitute technique. The scaffolds on which the autologous fibroblasts and keratinocytes were grown comprised an ester derivative of hyaluronic acid. Two applications of the cultured autologous fibroblasts and one of the cultured autologous keratinocytes were placed on the wound at 7-day intervals. The ulcer healed completely 60 days following the first fibroblast graft application. After 16 months of follow-up, no recurrence was noted and the patient can walk without ancillary support. This novel tissue engineering technique is a promising treatment for wound healing.
Cell suspensions of autologous keratinocytes or autologous fibroblasts accelerate the healing of full thickness skin wounds in a diabetic porcine wound healing model. [2009]Autologous dermal fibroblasts may be useful in the treatment of diabetic skin wounds. We hypothesized that cultured fibroblasts or cultured keratinocytes would not only survive in a hyperglycemic wound environment but also enhance the rate of re-epithelialization. We previously developed a new porcine model of delayed cutaneous wound healing in the diabetic pig. Full thickness wounds were created on the dorsum and dressed with polyurethane chambers to keep the wounds wet and to allow for wound fluid monitoring. Suspensions of either autologous fibroblasts or autologous keratinocytes were injected into full thickness wounds and compared with wounds treated in a wet environment in normal saline. Serum glucose and wound fluid glucose concentrations were monitored daily. Wound contraction was monitored and biopsies taken on day 12. Transplantation of suspensions of autologous fibroblasts or autologous keratinocytes enhanced re-epithelialization of cutaneous full thickness wounds. Wounds treated with autologous fibroblasts showed a re-epithelialization rate of 86.75% and wounds treated with autologous keratinocytes showed a re-epithelialization rate of 91.3%. This is compared with a re-epithelialization rate of 56.8% seen in the normal saline treated wounds. While previous studies have shown fibroblasts suspension to have little effect in the treatment of full thickness wounds in nondiabetic wounds, this study shows a clear beneficial effect in the use of fibroblast or keratinocyte suspensions for the cutaneous healing of diabetic wounds in pigs.
Tissue therapy with autologous dermal and epidermal culture cells for diabetic foot ulcers. [2018]A great part of diabetic ulcers on the lower extremities have difficult healing and represent the most common cause of non-traumatic amputation In case of patients unresponsive to the classical therapy with debridement, dressings and systemic antibiotic therapy, cell therapy may be an excellent indication. The objective of this study was to assess the efficacy of autologous skin cell (fibroblasts and keratinocytes) implants cultivated ex vivo and applied to long-standing (9-34 years) skin ulcers of five diabetic patients (4 DM2 and 1 DM1) with autologous fibrin glue. There were six ulcers of onset between 4 months and 20 years before and from 4.0 to 36.62 cm(2) in size, located on the lower limbs and unresponsive to the several conventional treatments. Complete healing was observed in five ulcers (83.3%), after 21-120 days. The patient who presented the largest ulcer had partial improvement in 40 days. It is believed that the more distal ulcer location is, the worse is its prognosis. There probably is a correlation between healing time, ulcer size and prior duration. No adverse reactions derived from the treatment occurred. It is concluded that this method is an excellent therapeutic option for diabetic ulcers, allowing faster healing. Its great advantage is being a minimally invasive procedure that can be carried out in an outpatient clinic.
[Preliminary clinical observations on autologous cultured skin fibroblasts transplantation to treat the facial soft tissue deficiencies]. [2013]To observe the effect and safety of autologous cultured skin fibroblasts transplantation for treating depressed facial skin defects.
Efficacy of fibroblast transplantation in the healing of cutaneous leishmaniasis scar: A case report. [2023]Autologous fibroblast transplantation has been proven to be a promising method in wound healing with no side effects. This is the first study aimed to determine the efficacy and safety of autologous fibroblast cell injection to the atrophic scar caused by cutaneous leishmaniasis as an endemic disease in many middle-eastern countries. It causes chronic skin lesions and permanently disfiguring scars. Autologous fibroblasts were obtained from the patient's ear skin and were injected intradermally twice at 2-month intervals. Outcomes were measured using ultrasonography, VisioFace, and Cutometer. No adverse reaction was observed. The results showed improvements in epidermal thickness and density, melanin level, and skin lightening. Moreover, the skin elasticity in the scar area increased after the second transplantation. No improvement was observed in dermal thickness and density. A longer follow-up with more patients is recommended to investigate the effectiveness of fibroblast transplantation better.