Mesenchymal Stromal Cells

Verum for Epidermolysis Bullosa

Masonic Cancer Center and Medical Center Minneapolis, Minneapolis, MN
allo-APZ2-OTS +1 morePhase 3Waitlist AvailableResearch Sponsored by RHEACELL GmbH & Co. KG

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).

Timeline

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

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

Find a site

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
~49 spots leftby Dec 2024