6 Participants Needed

ALLO-ASC-SHEET for Epidermolysis Bullosa

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Overseen ByFernanda Bellodi Schmidt
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Anterogen Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you require antibiotics for a bacterial infection on the target skin ulcer area, you may be excluded from the trial.

What data supports the effectiveness of the treatment ALLO-ASC-SHEET for Epidermolysis Bullosa?

Research shows that adipose-derived stem cells (ADSCs) can improve wound healing by promoting the growth of new skin cells and blood vessels, which suggests potential benefits for treating skin conditions like Epidermolysis Bullosa.12345

Is ALLO-ASC-SHEET safe for use in humans?

Research on adipose-derived stem cells, including allogeneic (from a donor) versions, suggests they are generally safe for use in humans, with no significant immune reactions or adverse events reported in clinical studies.46789

What makes the ALLO-ASC-SHEET treatment unique for Epidermolysis Bullosa?

ALLO-ASC-SHEET uses adipose-derived stem cells, which are unique because they can transform into different types of cells and help repair damaged skin. This treatment is novel as it leverages the regenerative potential of these stem cells to promote healing in conditions like Epidermolysis Bullosa, where traditional treatments are limited.125610

What is the purpose of this trial?

After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.

Eligibility Criteria

This trial is for individuals with dystrophic epidermolysis bullosa, confirmed by specific tests. Participants must have skin ulcers between 5-20 cm2 in size that are stable and not infected. Women who are pregnant, breastfeeding, or not using contraception if of childbearing potential cannot join.

Inclusion Criteria

I have been diagnosed with dystrophic epidermolysis bullosa confirmed by specific tests.
I have specific types of skin ulcers due to dystrophic epidermolysis bullosa.
I have two similar skin ulcers, each 5-20 cm2, that haven't changed much in size recently.
See 1 more

Exclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant and agree to use contraception during the trial.
I need antibiotics for a bacterial infection in the area of my skin ulcer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALLO-ASC-SHEET and Vehicle control treatments for target lesions

12 weeks
12 IP applications

Follow-up

Participants are monitored for safety and effectiveness after treatment

25 weeks

Treatment Details

Interventions

  • ALLO-ASC-SHEET
  • Vehicle Control
Trial Overview The study involves applying a new treatment called ALLO-ASC-SHEET to three skin lesions and a placebo (Vehicle control) to one lesion on the same person. The assignment of treatments to each lesion is decided randomly at enrollment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ALLO-ASC-SHEETExperimental Treatment1 Intervention
Allogeneic mesenchymal stem cells Dressing for Dystrophic Epidermolysis Bullosa wound
Group II: Conventional TherapyActive Control1 Intervention
Hydrogel Sheet Matching control

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anterogen Co., Ltd.

Lead Sponsor

Trials
31
Recruited
980+

Findings from Research

Adipose-derived stem cells (ASCs) enhance the proliferation and wound healing capabilities of keratinocytes and dermal fibroblasts, suggesting their potential role in skin repair.
The study found that ASC-conditioned medium (ASC-CM) not only promotes cell growth but also increases collagen production in fibroblasts, indicating that ASCs may aid in chronic wound healing through paracrine signaling.
Paracrine effects of adipose-derived stem cells on keratinocytes and dermal fibroblasts.Lee, SH., Jin, SY., Song, JS., et al.[2021]
Adipose-derived stem cells (ADSCs) and their secretory factors significantly promote hair growth by increasing the proliferation of human follicular cells and protecting dermal papilla cells from damage.
In animal studies, conditioned media from ADSCs not only induced the hair growth phase (anagen) but also enhanced hair shaft elongation, suggesting that ADSC-derived proteins could be effective treatments for hair loss in clinical settings.
The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors.Won, CH., Park, GH., Wu, X., et al.[2022]
Autologous adipose-derived stem cells (ASCs) from diabetic mice (DMA) demonstrated comparable effectiveness to nondiabetic ASCs in promoting wound healing, improving angiogenesis, and enhancing tissue regeneration in diabetic wounds, based on a study involving 36 db/db mice.
Despite some limitations in osteogenesis, DMAs showed similar capabilities in adipogenesis and overall therapeutic potential, suggesting that using a patient's own stem cells could be a viable treatment option for diabetic wounds without the risks associated with donor cells.
Autologous Diabetic Adipose-derived Stem Cells are Comparable to Allogeneic Non-diabetic Counterparts in Improving Diabetic Wound Healing.Chen, B., Wei, Y., Cai, J., et al.[2023]

References

Paracrine effects of adipose-derived stem cells on keratinocytes and dermal fibroblasts. [2021]
2.United Arab Emiratespubmed.ncbi.nlm.nih.gov
The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors. [2022]
Autologous Diabetic Adipose-derived Stem Cells are Comparable to Allogeneic Non-diabetic Counterparts in Improving Diabetic Wound Healing. [2023]
Autologous Adipose-Derived Stem Cell (Adsc) Transplantation In The Management Of Chronic Wounds. [2022]
Directing adipose-derived stem cells into keratinocyte-like cells: impact of medium composition and culture condition. [2019]
Human adipose-derived stem cells for the treatment of chemically burned rat cornea: preliminary results. [2013]
Clinical implication of allogenic implantation of adipogenic differentiated adipose-derived stem cells. [2021]
Adipose-derived stromal cells promote allograft tolerance induction. [2018]
Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. [2022]
During epithelial differentiation of human adipose-derived stromal/stem cells, expression of zonula occludens protein-1 is induced by a combination of retinoic acid, activin-A and bone morphogenetic protein-7. [2018]
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