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Stem Cell Therapy
allo-APZ2-CVU for Venous Leg Ulcers
Phase 3
Recruiting
Research Sponsored by RHEACELL GmbH & Co. KG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be at least 18 years old
Patients must have a chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler or Duplex sonography, ankle brachial index, physical examination, and dermatological review
Must not have
Uncontrolled Diabetes mellitus with Hemoglobin A1c >9.0%
Evidence of the ulcer extending to the underlying muscle, tendon, or bone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights
Pivotal Trial
Summary
This trial aims to study whether a new medication called allo-APZ2-CVU, when applied on chronic wounds that do not heal with standard treatment, is effective and safe compared to a fake
Who is the study for?
This trial is for individuals with chronic venous ulcers (CVUs) that haven't healed despite previous treatments. Specific details about who can join or reasons why someone might not be eligible are not provided.
What is being tested?
The trial tests allo-APZ2-CVU, a new treatment applied directly to non-healing CVUs, against a placebo to see if it's more effective and safe in healing these persistent leg ulcers.
What are the potential side effects?
Potential side effects of the new treatment are not detailed here. Typically, topical treatments may cause local reactions like redness, itching, or rash at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a long-lasting leg ulcer diagnosed by a doctor.
Select...
I am a woman who can have children and my pregnancy test was negative.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diabetes is not under control, with an A1c over 9.0%.
Select...
My ulcer has reached the muscle, tendon, or bone.
Select...
I have leg pain from poor circulation that needs treatment.
Select...
I was diagnosed with a blood clot in my vein recently or have one that's untreated.
Select...
My wound has shrunk by more than 40% since my last visit.
Select...
I cannot or do not want to use leg ulcer compression treatments.
Select...
I have an infected wound that needs treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete wound closure
Secondary study objectives
Complete wound closures at each post-baseline follow-up visit
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VerumExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
allo-APZ2-CVU
2017
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
FGK Clinical Research GmbHIndustry Sponsor
52 Previous Clinical Trials
6,400 Total Patients Enrolled
RHEACELL GmbH & Co. KGLead Sponsor
10 Previous Clinical Trials
428 Total Patients Enrolled
Anna MoessmerStudy DirectorRHEACELL GmbH & Co. KG