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Stem Cell Therapy
ALLO-ASC-SHEET for Diabetic Foot Ulcers
Phase 2
Waitlist Available
Led By David G. Armstrong, MD.Ph D.
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 is free of necrotic debris, exhibits no signs of clinical infection
Male or female subjects between 18 and 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow up to 24 weeks from the initial complete wound closure.
Awards & highlights
Study Summary
This trial will test if a new therapy for diabetic foot ulcers is effective and safe.
Who is the study for?
This trial is for adults aged 18-80 with Type I or II diabetes and foot ulcers lasting over 4 weeks. Eligible participants have good blood flow around the ulcer, no signs of infection, and a specific ulcer size and location. They must not have severe liver/renal failure, be HIV positive, pregnant/breastfeeding, or have had certain treatments recently.Check my eligibility
What is being tested?
The study tests ALLO-ASC-SHEET against a placebo hydrogel sheet to see if it's better at healing diabetic foot ulcers. It's double-blind meaning neither the researchers nor participants know who gets the real treatment versus placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to bovine proteins or fibrin glue in the product components as well as general complications related to wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ulcer is clean and shows no signs of infection.
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I am between 18 and 80 years old.
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I have a foot ulcer between 1 cm2 and 15 cm2 on the instep, border, or sole.
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I have a skin deep ulcer without muscle or bone exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow up to 24 weeks from the initial complete wound closure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up to 24 weeks from the initial complete wound closure.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Closure, Hospital
Secondary outcome measures
Changes in wound size compared to baseline between the two groups
Durability of complete wound closure
Closure, Hospital
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALLO-ASC-DFUExperimental Treatment1 Intervention
Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
Group II: Hydrogel SHEET(Vehicle control)Placebo Group1 Intervention
Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALLO-ASC-DFU
2016
Completed Phase 3
~380
Find a Location
Who is running the clinical trial?
Anterogen Co., Ltd.Lead Sponsor
29 Previous Clinical Trials
909 Total Patients Enrolled
9 Trials studying Foot Ulcer
617 Patients Enrolled for Foot Ulcer
David G. Armstrong, MD.Ph D.Principal InvestigatorUniversity of Southern California
Alexander M. Reyzelman, DPMPrincipal InvestigatorCenter for Clinical Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study's purpose and can follow its requirements.Your panel reactive antibody (PRA) levels are 20% or higher.I have severe liver problems.My ulcer is clean and shows no signs of infection.Your HbA1c level is higher than 10%.I need IV antibiotics for my wound infection.My blood sugar after eating is over 350 mg/dl.You are allergic to proteins from cows or fibrin glue.The blood flow around the ulcer is within certain levels measured by Doppler Test, Ankle Brachial Index (ABI), or Transcutaneous oxygen pressure (TcPO2).I have had cancer other than basal cell carcinoma in the last 5 years.I have severe kidney failure or am on dialysis.I have been on a stable dose of steroids or immunosuppressants for at least 4 weeks.I haven't had any biological wound treatments in the last 30 days.I cannot avoid putting weight on a certain part of my body.You have a history of alcohol or drug abuse that may affect your health.My ulcer is not caused by diabetes.I am between 18 and 80 years old.I am HIV positive.I currently have an infection with pus coming from a wound.My ulcer size changed by 30% or more in the week after my screening visit.I have a foot ulcer between 1 cm2 and 15 cm2 on the instep, border, or sole.I have a skin deep ulcer without muscle or bone exposure.I have diabetes and a foot ulcer that hasn't healed in over 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ALLO-ASC-DFU
- 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.
Does this clinical research permit the participation of those aged 70 and above?
"This research project is open to patients aged 18-80. There are 51 studies involving those below the age of consent and an additional 349 for elderly individuals exceeding 65 years old."
Answered by AI
Am I eligible to enroll in this research project?
"Qualified participants of this trial must be between the ages of 18 and 80, with a diagnosis of diabetic foot. Approximately 56 individuals are sought for participation."
Answered by AI
Is it still possible to register for this research endeavor?
"This experiment, which was initially published on the 2nd of January 2019 and has been recently updated on May 2nd 2022, is still searching for potential participants."
Answered by AI
What risks are involved with using ALLO-ASC-DFU therapeutically?
"Drawing from the Phase 2 data, our team at Power rates ALLO-ASC-DFU's safety as a 2. While there is evidence to support its security profile, no trial findings have proven its efficacy yet."
Answered by AI
How large is the collective cohort of individuals involved in this research endeavor?
"Affirmative. According to the research posted on clinicaltrials.gov, this investigation is actively enrolling participants. It was initially added on February 1st 2019 and most recently modified May 2nd 2022; 56 people are needed from one medical facility for the study's completion."
Answered by AI
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