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Stem Cell Therapy

allo-APZ2-EB for Dystrophic Epidermolysis Bullosa

Phase 1 & 2
Waitlist Available
Led By Jakub Tolar, MD, PhD
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial will investigate whether a new treatment for RDEB is effective and safe.

Eligible Conditions
  • Dystrophic Epidermolysis Bullosa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Assessment of adverse event (AE) occurrence
Overall improvement of EB symptoms after 12 weeks (measured by percentage change of a patient's EBDASI score), score), or last available post-baseline measurement if the Week 12 measurement is missing
Secondary outcome measures
Differences in patient's quality of life in EB
Inflammation (measured by panel of inflammation markers)
Itch assessment as per NRS
+13 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: allo-APZ2-EBExperimental Treatment1 Intervention
intravenous infusion, three doses of allo-APZ2-EB (2 x 10^6 cells/kg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
allo-APZ2-EB
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

RHEACELL GmbH & Co. KGLead Sponsor
9 Previous Clinical Trials
460 Total Patients Enrolled
FGK Clinical Research GmbHIndustry Sponsor
50 Previous Clinical Trials
6,267 Total Patients Enrolled
Granzer Regulatory Consulting & ServicesOTHER
6 Previous Clinical Trials
136 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa
2019. "Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03529877.
~3 spots leftby Apr 2025
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