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Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa

NCT03529877 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-10-07

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).

Conditions

Interventions

BIOLOGICAL

allo-APZ2-EB

intravenous infusion of allo-APZ2-EB

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Granzer Regulatory Consulting & Services

    collaborator OTHER

  • Ticeba GmbH

    collaborator INDUSTRY

  • RHEACELL GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Jakub Tolar, MD, PhD · University of Minnesota, Masonic Cancer Center and Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-16
Primary Completion
2021-11-26
Completion
2021-11-26
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529877 on ClinicalTrials.gov