ALLO-ASC-SHEET for Diabetic Foot Ulcer

Overseen By Yun Jung Choi, PM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Anterogen Co., Ltd.

Must not be taking: Antibiotics, Corticosteroids, Immunosuppressives, others

Disqualifiers: HIV, Hepatic deficiencies, Renal insufficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on high-dose antibiotics, certain steroids, or immunosuppressive drugs. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment ALLO-ASC-SHEET for diabetic foot ulcers?

Research shows that using allogeneic adipose-derived stem cell sheets can significantly improve wound healing in diabetic foot ulcers, with 82% of patients achieving complete wound closure in 12 weeks compared to 53% in the control group. This suggests that the treatment is effective and safe for promoting healing in diabetic wounds. ^{1 2 3 4 5}

Is ALLO-ASC-SHEET safe for treating diabetic foot ulcers?

Research indicates that ALLO-ASC-SHEET, which contains adipose-derived stem cells, is generally safe for treating diabetic foot ulcers, as no serious adverse events were reported in a study involving 59 patients. ^{1 4 5 6 7}

What makes the ALLO-ASC-SHEET treatment unique for diabetic foot ulcers?

The ALLO-ASC-SHEET treatment is unique because it uses allogeneic adipose-derived stem cells (ASCs) to promote wound healing in diabetic foot ulcers. These stem cells are applied as a sheet directly to the wound, accelerating healing by secreting growth factors that enhance blood vessel formation and tissue repair, which is different from traditional treatments that may not involve stem cells. ^{2 3 4 5 8}

What is the purpose of this trial?

This trial is testing a special cell-based sheet called ALLO-ASC-SHEET to help heal foot ulcers in diabetic patients. The sheet creates a good environment for the wound to heal faster.

Research Team

Yun Jung Choi, PM

Principal Investigator

Anterogen Co., Ltd.

Eligibility Criteria

Adults aged 18-80 with Type I or II diabetes and a Wagner Grade II foot ulcer between 1.5 cm2 and 15 cm2 that hasn't reached the bone, is free of dead tissue and infection, has good blood flow around it, and has been present for over 4 weeks. Excludes those with certain immune responses, non-diabetic ulcers, severe infections or liver/kidney issues, high HbA1c levels (>10%), allergies to specific proteins or glues, recent other treatments or trials participation.

Inclusion Criteria

The blood circulation around the ulcer meets one of the following criteria: A. Blood flow around the ulcer is checked using Doppler Test and shows specific patterns. B. The range of Ankle Brachial Index (ABI) is within a certain range. C. The transcutaneous oxygen pressure (TcPO2) is above a certain level.

I have a grade II ulcer that affects muscle or tendon but not bone.

My ulcer is clean and shows no signs of infection.

Exclusion Criteria

Is considered by the Investigator to have a significant disease which might impact the study

I have had cancer other than basal cell carcinoma in the last 5 years.

I cannot avoid putting weight on a certain part of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALLO-ASC-SHEET or placebo for diabetic foot ulcers

12 weeks

Regular visits for wound assessment

Follow-up

Participants are monitored for durability of complete wound closure

24 weeks

Treatment Details

Interventions

• ALLO-ASC-SHEET

Trial Overview This phase 2 trial tests ALLO-ASC-SHEET's effectiveness in healing diabetic foot ulcers compared to a placebo. It's double-blind meaning neither participants nor researchers know who gets the real treatment versus placebo during the study.

Participant Groups

Group I: ALLO-ASC-SHEET Experimental Treatment 1 Intervention

ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Group II: Hydrogel SHEET(Vehicle control) Placebo Group 1 Intervention

Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells

Who Is Running the Clinical Trial?

Anterogen Co., Ltd.

Lead Sponsor

Trials

31

Recruited

980+

Findings from Research

A review of 11 randomized controlled trials found that adding allogeneic skin substitutes and human placental membrane allografts to standard wound care significantly increases the healing rates of diabetic foot ulcers (DFUs) at 6 and 12 weeks.

One study suggested that placental membrane allografts may be more effective than allogeneic skin substitutes, but more research is needed to confirm this finding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Skin Substitutes Versus Human Placental Membrane Products in the Management of Diabetic Foot Ulcers: A Narrative Comparative Evaluation of the Literature. Luck, J., Rodi, T., Geierlehner, A., et al.[2019]

A 57-year-old woman with a 20-day diabetic foot ulcer (DFU) showed significant healing after treatment with placenta-derived mesenchymal stem cells (PDMSCs) hydrogel, indicating its potential efficacy in wound repair.

The treatment was safe, with no complications or recurrence of the ulcer observed over a 6-month follow-up period, suggesting that PDMSCs hydrogel could be a promising new approach for managing DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-week topical treatment with placenta-derived mesenchymal stem cells hydrogel in a patient with diabetic foot ulcer: A case report. Zeng, X., Tang, Y., Hu, K., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 59 patients with diabetic foot ulcers, treatment with allogeneic adipose-derived stem cell (ASC) sheets resulted in a significantly higher rate of complete wound closure compared to a control group using polyurethane film, achieving 82% closure by week 12 versus 53%.

The treatment with ASC sheets was found to be safe, with no serious adverse events reported, suggesting that allogeneic ASCs could be a promising option for effectively treating diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. Moon, KC., Suh, HS., Kim, KB., et al.[2019]

Transplanting allogeneic adipose-derived stem cell (ASC) sheets into diabetic rats with full-thickness skin defects significantly accelerated wound healing and improved blood vessel formation within 2 weeks, indicating their potential effectiveness for treating nonhealing diabetic ulcers.

The ASC sheets not only promoted healing directly but also enhanced the formation of new blood vessels by secreting angiogenic growth factors, suggesting a dual mechanism of action in improving wound recovery in diabetic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Transplantation of an Adipose-Derived Stem Cell Sheet Combined With Artificial Skin Accelerates Wound Healing in a Rat Wound Model of Type 2 Diabetes and Obesity. Kato, Y., Iwata, T., Morikawa, S., et al.[2022]

In a study involving 16 patients with diabetic foot ulcers (DFUs) that had not healed with standard treatments, the use of autologous skin cell suspension (ASCS) combined with standard therapy resulted in a significant average reepithelialization of 84.9% and a reduction in ulcer area by 12.2 cm² over 26 weeks.

All ulcers showed positive healing trajectories, with those free from soft tissue infections achieving either complete healing or at least 95% reepithelialization, indicating that ASCS is a promising and well-tolerated treatment option for DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility study of non-cultured autologous skin cell suspension for healing diabetic foot ulcers. Rashid, ST., Cavale, N., Bowling, FL.[2021]

Exosomes from mmu_circ_0001052-modified adipose-derived stem cells (ADSCs) significantly enhance wound healing in diabetic foot ulcers (DFU) by promoting angiogenesis through the miR-106a-5p and FGF4/p38MAPK pathway.

The study demonstrated that these exosomes reduce apoptosis and increase proliferation and migration of high glucose-induced human umbilical vein endothelial cells (HUVECs), indicating their potential as a therapeutic intervention for DFU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exosomes from mmu_circ_0001052-modified adipose-derived stem cells promote angiogenesis of DFU via miR-106a-5p and FGF4/p38MAPK pathway. Liang, ZH., Pan, NF., Lin, SS., et al.[2022]

Mesenchymal stem cells (MSCs) have shown promise in treating diabetic foot ulcers (DFU) by accelerating wound healing and improving clinical outcomes, potentially reducing the need for amputations.

Bone marrow-derived MSCs (BM-MSCs) are highlighted as a particularly effective and cost-efficient option for transplantation in DFU treatment, offering a safe alternative with no ethical concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells Improve Healing of Diabetic Foot Ulcer. Cao, Y., Gang, X., Sun, C., et al.[2022]

References

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

Allogeneic Skin Substitutes Versus Human Placental Membrane Products in the Management of Diabetic Foot Ulcers: A Narrative Comparative Evaluation of the Literature. [2019]

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

Three-week topical treatment with placenta-derived mesenchymal stem cells hydrogel in a patient with diabetic foot ulcer: A case report. [2022]

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

Autologous Diabetic Adipose-derived Stem Cells are Comparable to Allogeneic Non-diabetic Counterparts in Improving Diabetic Wound Healing. [2023]

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

Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. [2019]

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

Allogeneic Transplantation of an Adipose-Derived Stem Cell Sheet Combined With Artificial Skin Accelerates Wound Healing in a Rat Wound Model of Type 2 Diabetes and Obesity. [2022]

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

A pilot feasibility study of non-cultured autologous skin cell suspension for healing diabetic foot ulcers. [2021]

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

Exosomes from mmu_circ_0001052-modified adipose-derived stem cells promote angiogenesis of DFU via miR-106a-5p and FGF4/p38MAPK pathway. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells Improve Healing of Diabetic Foot Ulcer. [2022]