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Mesenchymal Stromal Cells

Stem Cell Therapy for Epidermolysis Bullosa

Q: Has Verum attained the necessary regulatory clearance from the FDA?

<p>According to our evaluation, verum has been awarded a safety rating of 3 due its successful completion of Phase 3 trials and the collected data illustrating efficacy.</p>

Q: Are researchers still enrolling participants for this investigation?

<p>As per the information listed on clinicaltrials.gov, this trial is not currently enrolling participants. The study was first posted June 1st 2023 and last updated April 20th 2023. At present there are 24 other trials actively recruiting individuals for their studies.</p>

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

Male or female subjects from 6 months of age with a diagnosis of RDEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping

Subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and < 9 months, no signs of acute infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test if a new drug can be safely and effectively used to treat a rare skin condition called Recessive Dystrophic Epidermolysis Bullosa (RDEB).

Who is the study for?

This trial is for males and females from 6 months old with confirmed recessive dystrophic epidermolysis bullosa (RDEB). Participants must have a specific wound type, be in good general health, and understand the study. Women who can have children need a negative pregnancy test and agree to use birth control.Check my eligibility

What is being tested?

The trial tests allo-APZ2-OTS, an intravenous treatment for RDEB against a placebo. The goal is to see if it's safe and works better than not receiving the active treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to infusion or immune response due to the nature of stem cell treatments.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have RDEB confirmed by genetic testing or skin biopsy.

Select...

My wound is between 5-50 cm2, older than 21 days but less than 9 months, and not infected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects with complete target wound closure

Secondary outcome measures

Time to complete target wound closure from baseline

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VerumExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

RHEACELL GmbH & Co. KGLead Sponsor

9 Previous Clinical Trials

402 Total Patients Enrolled

2 Trials studying Epidermolysis Bullosa

90 Patients Enrolled for Epidermolysis Bullosa

Media Library

allo-APZ2-OTS (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT05838092 — Phase 3

Epidermolysis Bullosa Research Study Groups: Verum, Placebo

Epidermolysis Bullosa Clinical Trial 2023: allo-APZ2-OTS Highlights & Side Effects. Trial Name: NCT05838092 — Phase 3

allo-APZ2-OTS (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838092 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Verum attained the necessary regulatory clearance from the FDA?

"According to our evaluation, verum has been awarded a safety rating of 3 due its successful completion of Phase 3 trials and the collected data illustrating efficacy."

Answered by AI

Are researchers still enrolling participants for this investigation?

"As per the information listed on clinicaltrials.gov, this trial is not currently enrolling participants. The study was first posted June 1st 2023 and last updated April 20th 2023. At present there are 24 other trials actively recruiting individuals for their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)

2023. "Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838092.

All > Epidermolysis Bullosa