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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 36 weeks
Awards & highlights
Study Summary
This trial will test if a new treatment for diabetic foot ulcers is more effective than placebo.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a grade II ulcer that affects muscle or tendon but not bone.
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My ulcer is clean and shows no signs of infection.
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I have a foot ulcer between 1.5 and 15 cm2 in size.
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I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 36 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportions of subjects who achieved complete wound closure.
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Anterogen Co., Ltd.Lead Sponsor
29 Previous Clinical Trials
901 Total Patients Enrolled
9 Trials studying Foot Ulcer
609 Patients Enrolled for Foot Ulcer
Yun Jung Choi, PMStudy DirectorAnterogen Co., Ltd.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I haven't had treatments like growth factors for wounds in the last 30 days.I am HIV positive.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 currently have an infection with pus coming from a wound.My skin lesion was confirmed not to be a diabetic foot ulcer but something else after a biopsy.My kidney function is severely impaired with high creatinine levels.I am not on high-dose steroids or immune-suppressing drugs with changes in the last 4 weeks.Your HbA1c level is higher than 10%.I have a grade II ulcer that affects muscle or tendon but not bone.You are allergic to proteins from cows or fibrin glue.My ulcer is clean and shows no signs of infection.Your panel reactive antibody (PRA) levels are 20% or higher at screening.My ulcer is not caused by diabetes.I currently have an infection or signs of infection like fever or drainage from a wound.My ulcer size changed by 30% or more in the last 2 weeks.My wound is longer than 15 cm.I have severe liver problems.Your blood sugar after eating is higher than 350 mg/dL during the screening.You have a history of alcohol or drug abuse that has affected your health.You test positive for venereal disease.I have a foot ulcer between 1.5 and 15 cm2 in size.I am between 18 and 80 years old.I am on a higher dose or different antibiotics than initially prescribed for my foot infection.I have diabetes and a foot ulcer not healing for over 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ALLO-ASC-SHEET
- Group 2: Hydrogel SHEET(Vehicle control)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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