Autologous Skin Grafts for Wounds and Injuries

Overseen By Ruizhi Wang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Autoimmune, Cancer, HIV, Diabetes, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating wounds by using a person’s own skin cells to create thicker skin, similar to that on palms or soles. Researchers aim to transform regular skin into this tougher type to improve injury healing. The trial involves injecting Autologous Skin Fibroblasts (also known as Autologous Volar Fibroblast Injection) into three different skin areas to determine the most effective method. It suits individuals with healthy skin who can adhere to the study's schedule and procedures, including visits and wound care. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will 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 people on chronic immunosuppressive therapies like oral steroids or chronic topical steroids in the area of investigation.

Is there any evidence suggesting that autologous skin fibroblasts are likely to be safe for humans?

Research has shown that injections of a person's own skin cells, called fibroblasts, are generally safe and well-tolerated. In past studies, these cells, which aid in wound healing, did not cause major safety issues in healthy adults. The cells are taken from the skin on the palm or sole, potentially helping to thicken the skin. Another study noted that these injections were safe enough to receive approval for use in other medical areas. While no treatment is entirely risk-free, current evidence suggests that these injections have a strong safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for wounds and injuries, which often rely on synthetic grafts or donor skin, autologous skin fibroblasts use the patient’s own cells to promote healing. This approach minimizes the risk of rejection and infection since it’s derived from the individual’s own tissues. Researchers are particularly excited about the potential for faster and more natural healing, as the treatment directly involves the body’s own repair mechanisms and can be tailored to the specific needs of each patient. By comparing different injection sites within the same individual, this method also allows for personalized treatment strategies and potentially improved outcomes.

What evidence suggests that autologous skin fibroblasts might be an effective treatment for wounds and injuries?

Research shows that using a person's own skin cells, called fibroblasts, can improve skin quality. In this trial, participants will receive injections of autologous skin fibroblasts at three different sites. Studies have found that injecting these cells, especially from the palms or soles, can make the skin firmer and thicker, similar to the tougher skin on those areas. In animal studies, these fibroblasts helped wounds heal faster by speeding up skin growth. Overall, early evidence suggests that using one's own skin cells could be promising for improving skin conditions and healing wounds. ^{1 3 4 5 6}

Who Is on the Research Team?

Luis Garza, MD, PhD

Principal Investigator

Department of Dermatology, Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

Adults aged 18-65 with healthy skin who can follow the study's procedures, including visits and wound care. Women must test negative for pregnancy, not plan to become pregnant or breastfeed during the study, and use contraception. Excluded are those with allergies to study materials, certain medical conditions like autoimmune diseases or uncontrolled diabetes, active smokers, or on chronic immunosuppressive therapies.

Inclusion Criteria

I am willing to use birth control during the study.

I agree not to get pregnant or breastfeed during and for 1 month after the study.

In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality

Exclusion Criteria

I have a known bleeding disorder.

Having received any investigational drug within 30 days prior to study entry

An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Autologous skin fibroblasts are injected into different skin sites to observe changes

6 months

Multiple visits for injections and monitoring

Follow-up

Participants are monitored for changes in skin characteristics and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Skin Fibroblasts

Trial Overview The trial is testing if it's possible to transform normal skin into thicker palm/sole-type skin using autologous (patient's own) skin fibroblasts. Participants will undergo a procedure where these cells are injected into their normal skin.

How Is the Trial Designed?

Group I: autologous skin fibroblasts Experimental Treatment 2 Interventions

The investigators are comparing 3 injection sites in the same individual

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Maryland Stem Cell Research Fund

Collaborator

Trials

1

Recruited

1+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

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 involved 19 patients who received autologous cultured skin fibroblast injections to treat depressed facial skin defects, showing significant improvement in skin appearance after treatment.

The procedure was found to be safe, with only minor adverse events reported, and no serious complications or excessive cell proliferation, indicating that this method could be a reliable option for facial skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary clinical observations on autologous cultured skin fibroblasts transplantation to treat the facial soft tissue deficiencies]. Zeng, W., Wei, ZR., Liu, D., et al.[2013]

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]

Cultured fibroblasts (CF) can be successfully transplanted into full-thickness skin wounds, where they integrate into the new dermis and significantly accelerate the reepithelialization process, improving wound healing outcomes.

When CF are cotransplanted with cultured keratinocytes (CK), they enhance the proliferation of keratinocyte colonies and further speed up wound healing compared to CK alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultured autologous fibroblasts augment epidermal repair. Svensjö, T., Yao, F., Pomahac, B., et al.[2019]

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 20 patients aged 37-61, autologous dermal fibroblasts were successfully used for facial soft tissue augmentation, leading to significant and sustained clinical improvements in facial rhytides and atrophic scars.

The fibroblasts used were functionally active, producing large amounts of type I collagen, and showed no oncogenic properties or tumor formation in animal models, indicating a safe profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of injectable autologous human fibroblasts. Keller, G., Sebastian, J., Lacombe, U., et al.[2019]

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]

In a study using a porcine model of delayed wound healing, both autologous fibroblasts and keratinocytes significantly improved the re-epithelialization rates of diabetic skin wounds, achieving rates of 86.75% and 91.3%, respectively, compared to only 56.8% in saline-treated wounds.

This research suggests that while fibroblast suspensions have shown limited effectiveness in non-diabetic wounds, they can be beneficial for enhancing healing in diabetic wounds, indicating a potential new treatment strategy for diabetic skin injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell suspensions of autologous keratinocytes or autologous fibroblasts accelerate the healing of full thickness skin wounds in a diabetic porcine wound healing model. Velander, P., Theopold, C., Bleiziffer, O., et al.[2009]

Citations

1. 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, ...

2. clinicaltrial.be clinicaltrial.be/en/details/63733?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Autologous Volar Fibroblast Injection Into the Stump Site... The objective of this study is to determine if fibroblast (from palm or sole) injections are safe and effective at increasing epidermal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01964859

Feasibility Study for Fibroblast Autologous Skin Grafts | ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. withpower.com withpower.com/trial/phase-3-8-2019-b4baf

Fibroblast Injection for Amputation Healing In a study using a porcine model of delayed wound healing, both autologous fibroblasts and keratinocytes significantly improved the re-epithelialization rates ...

5. science.org science.org/doi/10.1126/science.adr9294

Transplanted fibroblasts take the pressure Injection of volar fibroblasts into nonvolar skin resulted in increased volar features, including greater epidermal thickness and elevated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4057739/

Alteration of Skin Properties with Autologous Dermal ... We outline the role of fibroblasts in wound healing and discuss recent advances and the current development pipeline for cellular therapies using autologous ...