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

Trial Summary

What is the purpose of this trial?

This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.

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.

What data supports the effectiveness of the treatment Autologous Skin Fibroblasts for wounds and injuries?

Research shows that using a patient's own fibroblasts (a type of skin cell) can help improve skin healing and appearance, as seen in cases of scars from conditions like cutaneous leishmaniasis and acne. Patients have reported satisfaction with the treatment, and studies have noted improvements in skin elasticity and appearance without side effects. ^{1 2 3 4 5}

Is autologous skin graft treatment safe for humans?

Research shows that autologous skin grafts, using cultured fibroblasts, are generally safe for humans. Studies have reported no serious adverse reactions, and no tumors were induced in animal tests, indicating a good safety profile. ^{3 4 5 6 7}

How is the treatment Autologous Skin Fibroblasts unique for wound healing?

Autologous Skin Fibroblasts involve using a patient's own skin cells to promote healing, which is unique because it reduces the risk of rejection and side effects. This treatment enhances skin repair by increasing skin elasticity and re-epithelialization (the process of new skin formation), making it particularly effective for chronic wounds and scars. ^{1 3 4 6 8}

Research Team

Luis Garza, MD, PhD

Principal Investigator

Department of Dermatology, Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: autologous skin fibroblasts Experimental Treatment 1 Intervention

we 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+

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cultured autologous fibroblasts augment epidermal repair. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Autologous cultured fibroblasts as cellular therapy in plastic surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of fibroblast transplantation in the healing of cutaneous leishmaniasis scar: A case report. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Autologous cultured fibroblasts: a protein repair system. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Preliminary clinical observations on autologous cultured skin fibroblasts transplantation to treat the facial soft tissue deficiencies]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of injectable autologous human fibroblasts. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds. [2023]

8. United States 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. [2009]