ALLO-ASC-SHEET for Epidermolysis Bullosa
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Anterogen Co., Ltd.
Must not be taking: Antibiotics
Disqualifiers: Pregnancy, Breastfeeding, Others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
46789What 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.
125610Eligibility 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.
+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.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Miami Dermatology Clinical Trials UnitMiami, FL
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Who Is Running the Clinical Trial?
Anterogen Co., Ltd.Lead Sponsor
References
Paracrine effects of adipose-derived stem cells on keratinocytes and dermal fibroblasts. [2021]Adipose-derived stem cells (ASCs) are mesenchymal stem cells that have recently been applied to tissue repair and regeneration. Keratinocytes and dermal fibroblasts play key roles in cutaneous wound healing.
The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors. [2022]Adipose-derived stem cells (ADSCs) are mesenchymal stem cells (MSCs) within the stromal vascular fraction of subcutaneous adipose tissue. ADSCs secrete growth factors and other proteins, and have been used to regenerate skin with satisfactory results.
Autologous Diabetic Adipose-derived Stem Cells are Comparable to Allogeneic Non-diabetic Counterparts in Improving Diabetic Wound Healing. [2023]Adipose tissue-derived stem cell (ASC) therapy is considered a promising strategy for improving impaired wound healing, especially in diabetics. While the therapeutic potential of allogeneic ASCs from healthy donors is naturally limited, that of autologous ASCs from diabetic patients is questionable. The aim of this study was to investigate the impact of diabetic ASCs in the treatment of diabetic wounds.
Autologous Adipose-Derived Stem Cell (Adsc) Transplantation In The Management Of Chronic Wounds. [2022]Our aim is to characterize chronic wound response to autologous adipose-derived stem cell (ADSC) sheet transplantation. A pilot descriptive longitudinal study was conducted at the Wound Healing Center of the Vietnam National Burn Hospital from July 1, 2019 to August 30, 2020. Thirty patients with 38 chronic wounds were enrolled in the study and were grafted with autologous ADSC sheets on the wound bed. Wound edges, wound bed, wound size and structure using H&E staining, ultrastructure changes by transmission electron microscope at the time of transplantation and at the first, second and third week of follow-up were observed. Results indicated that after ADSC sheet transplantation, the structure and ultrastructure of chronic wounds had improved. The extracellular matrix (ECM), neo-vascular, fibroblast and collagen fibers proliferated and arranged side by side at the dermis layer. Fibroblast proliferated and increased secretion of collagen. Keratinocytes proliferated and immigrated in the epidermis layer. After three weeks of autologous ADSC sheet transplantation, epithelial cells covered 90% of the wound surface. Neo-vascular, fibroblast and collagen proliferation increased weekly. The image of lymphocyte infiltration in connective tissues decreased. Wound size reduced significantly compared to before the experiment, wound beds were cleaner and filled with granulation tissue. Re-epithelialization appeared at the wound edge and throughout the wound. Wound measurements were statistically significant at the second and third weeks after starting treatment (week 2: 12.8±11.56 cm2 [range: 1-47.42 cm2], p
Directing adipose-derived stem cells into keratinocyte-like cells: impact of medium composition and culture condition. [2019]Adipose-derived stem cells (ASC) are known to transdifferentiate into a wide range of different cell species in vitro including along the epidermal lineage. This property makes them a promising tool for regenerative medicine to restore the epidermal barrier.
Human adipose-derived stem cells for the treatment of chemically burned rat cornea: preliminary results. [2013]Adipose-derived stem cells (ADSC) are multipotent, safe, non-immunogenic and can differentiate into functional keratocytes in situ. The topical use of ADSC derived from human processed lipoaspirate was investigated for treating injured rat cornea.
Clinical implication of allogenic implantation of adipogenic differentiated adipose-derived stem cells. [2021]We recently reported that autologous adipogenic differentiated adipose-derived stem cells (ASCs) can potentially be used as an effective and safe therapy for soft-tissue regeneration. In the present study, we investigated whether adipogenic differentiated ASCs can be used for allogenic applications to enlarge their therapeutic use. The allogenic immune response of adipogenic differentiated ASCs was investigated by flow cytometry and mixed lymphocyte culture. To determine whether adipogenic differentiated ASCs can form new adipose tissue without immune rejection, these cells were implanted subcutaneously into allo- or xenogenic recipient mice. In addition, the safety of the allogenic implantation of adipogenic differentiated ASCs was explored in a phase I clinical study. Adipogenic differentiated ASCs do not express major histocompatibility complex (MHC) class II molecules and costimulatory molecules, and the expression levels of MHC class I decreased after differentiation. In addition, these cells do not elicit an immune response against MHC-mismatched allogenic lymphocytes and formed new adipose tissue without immune rejection in the subcutaneous region of MHC-mismatched mice. Moreover, these cells did not induce clinically significant local and systemic immune responses or adverse events in the subcutaneous region of donor-independent healthy subjects. These results suggest that adipogenic differentiated ASCs can be used as a "universal donor" for soft-tissue engineering in MHC-mismatched recipients.
Adipose-derived stromal cells promote allograft tolerance induction. [2018]Amputations and unsalvageable injuries with devastating tissue loss are common in the combat wounded. Reconstructive transplantation in the civilian setting using vascular composite allotransplants (VCAs) with multiple tissues (skin, muscle, nerve, bone) combined with long-term multidrug immunosuppression has been encouraging. However, skin rejection remains a critical complication. Adipose-derived stromal/stem cells (ASCs) are easily obtained from normal individuals in high numbers, precluding ex vivo expansion. The reparative function and paracrine immunomodulatory capacity of ASCs has gained considerable attention. The present study investigated whether ASCs facilitate long-term skin allograft survival. ASCs were isolated from fresh human subcutaneous adipose lipoaspirate. Full-thickness skin grafts from BALB/c mice were transplanted onto the dorsal flanks of C57BL/6 mice treated with five doses of anti-CD4/CD8 monoclonal antibodies (10 mg/kg) on days 0, +2, +5, +7, and +14 relative to skin grafting. A single nonmyeloablative low dose of busulfan (5 mg/kg) was given on day +5. Seven days after skin transplantation, ASCs (3×10(6)) were infused i.v. with or without donor bone marrow cells (BMCs; 5×10(5)). ASC+BMC coinfusion with minimal conditioning led to stable lymphoid and myeloid macrochimerism, deletion of alloreactive T cells, expansion of regulatory T cells, and long-term allograft survival (>200 days). ASCs constitutively produced high levels of anti-inflammatory/immunoregulatory factors such as prostaglandin E2, indoleamine 2,3-dioxygenase, APO-1/Fas (CD95), and programmed cell death-1 ligand-2. These findings serve as a foundation for developing a translational advanced VCA protocol, embodying both ASCs and low-dose donor BMCs, in nonhuman primates, with the goal of enhancing functional outcomes and eliminating the complications associated with long-term immunosuppression.
Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. [2022]The feasibility and safety of stem cell-based therapy with expanded adipose-derived stem cells (ASCs) has been investigated in a phase I clinical trial. The present study was designed as a phase II multicenter, randomized controlled trial to further investigate the effectiveness and safety of ASCs in the treatment of complex perianal fistulas.
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]Adipose-derived stromal/stem cells (ASC) possess a multilineage differentiation potential, can be used from an autologous origin, and are, therefore, attractive candidates for clinical applications to repair or regenerate damaged tissues and organs. Beside their well-known differentiation into cells of mesodermal origin, ASC are able to differentiate into cells of ecto- and endodermal origin.