What is the mechanism of action of this treatment?

The most common treatments for foot ulcers, particularly those involving stem cell therapy like ALLO-ASC-SHEET, work by promoting wound healing and tissue regeneration. Allogeneic adipose-derived stem cells (ASCs) are known to enhance the repair process by differentiating into various cell types, secreting growth factors, and modulating the immune response to reduce inflammation. This is crucial for foot ulcer patients as it accelerates healing, reduces the risk of infection, and potentially lowers the need for amputations. Other treatments, such as debridement, infection control, and pressure offloading, also play significant roles but do not directly contribute to tissue regeneration as stem cell therapies do.

What side effects are associated with this type of intervention?

Common side effects of treatments for foot ulcers, particularly those involving stem cell therapies like ALLO-ASC-SHEET, include mild to moderate reactions at the application site such as redness, swelling, and pain. Systemic side effects can include fever, rash, and hypersensitivity reactions. There is also a potential risk of infection or immune response to the allogeneic cells. Close monitoring is essential to manage any adverse effects promptly.

What prior FDA approvals exist?

The FDA has approved several treatments for foot ulcers, particularly those associated with diabetes. These include advanced wound care products like Apligraf and Dermagraft, which are bioengineered skin substitutes that promote wound healing and tissue regeneration. Apligraf is composed of living cells and structural proteins, while Dermagraft consists of fibroblasts on a bioabsorbable scaffold. Both have shown efficacy in treating diabetic foot ulcers by enhancing the body's natural healing processes. While specific stem cell therapies like ALLO-ASC-SHEET are still under investigation, these approved treatments share a similar goal of promoting wound healing and tissue regeneration.

What other types of research exist?

Promising alternatives to ALLO-ASC-SHEET for foot ulcer patients include: 1) Genetically modified autologous cultured skin grafts, which have shown stable and complete epidermal regeneration in severe cases of epidermolysis bullosa. 2) Beremagene geperpavec (B-VEC), a gene therapy using a modified herpes simplex virus to deliver functional genes directly to skin cells, demonstrated significant wound healing in dystrophic epidermolysis bullosa. Both therapies have shown potential in promoting wound healing and tissue regeneration in clinical studies.

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Stem Cell Therapy

ALLO-ASC-SHEET for Diabetic Foot Ulcer

Phase 2

Recruiting

Research Sponsored by Anterogen Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone

Ulcer is free of necrotic debris, exhibits no signs of clinical infection

Must not have

Have a history of malignancy within the last 5 years (except basal cell carcinoma in situ)

Cannot maintain off-loading process

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 36 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, potential side effects may include local reactions at the application site such as redness or irritation; allergic reactions due to bovine-derived materials; general discomfort; or complications related to underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My ulcer is clean and shows no signs of infection.

Select...

I have a foot ulcer between 1.5 and 15 cm2 in size.

Select...

I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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

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I haven't had treatments like growth factors for wounds in the last 30 days.

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I am HIV positive.

Select...

I currently have an infection with pus coming from a wound.

Select...

My kidney function is severely impaired with high creatinine levels.

Select...

My ulcer is not caused by diabetes.

Select...

I currently have an infection or signs of infection like fever or drainage from a wound.

Select...

My ulcer size changed by 30% or more in the last 2 weeks.

Select...

My wound is longer than 15 cm.

Select...

I have severe liver problems.

Select...

I am on a higher dose or different antibiotics than initially prescribed for my foot infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportions of subjects who achieved complete wound closure.

Secondary study objectives

Changes in wound size compared to baseline between the 2 groups.

Durability of complete wound closure for the additional 24 weeks.

Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALLO-ASC-SHEETExperimental Treatment1 Intervention

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

Group II: Hydrogel SHEET(Vehicle control)Placebo Group1 Intervention

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for foot ulcers, particularly those involving stem cell therapy like ALLO-ASC-SHEET, work by promoting wound healing and tissue regeneration. Allogeneic adipose-derived stem cells (ASCs) are known to enhance the repair process by differentiating into various cell types, secreting growth factors, and modulating the immune response to reduce inflammation. This is crucial for foot ulcer patients as it accelerates healing, reduces the risk of infection, and potentially lowers the need for amputations. Other treatments, such as debridement, infection control, and pressure offloading, also play significant roles but do not directly contribute to tissue regeneration as stem cell therapies do.

Treatment of Diabetic Foot with Autologous Stem Cells: A Meta-Analysis of Randomized Studies.Autologous stem cell therapy for peripheral arterial disease: a systematic review and meta-analysis of randomized controlled trials.