Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05838092 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Epidermolysis Bullosa, sponsored by RHEACELL GmbH & Co. KG.

Active
Registry status
Phase 3
Development phase
9
Enrollment target
2
Study locations

NCT05838092: Active Phase 3 study of Epidermolysis Bullosa, sponsored by RHEACELL GmbH & Co. KG.

NCT05838092 is a Phase 3 study of Epidermolysis Bullosa that is active but no longer recruiting, run by RHEACELL GmbH & Co. KG. The registered enrollment target is 9 participants, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05838092, a Phase 3 study of Epidermolysis Bullosa, is active but no longer recruiting, sponsored by RHEACELL GmbH & Co. KG.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
9 participants
Enrollment target
2
Study locations

Study Summary

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with JEB and to RDEB subjects \< 1 year.

Primary Outcome

Proportion of subjects with complete healing of target wound, determined by the investigator, as compared to baseline

Conditions Studied

Epidermolysis Bullosa

Interventions

  • DRUG Placebo
  • DRUG allo-APZ2-OTS

Study Locations (2)

Colorado

  • Children's Hospital Colorado - Aurora

Minnesota

  • Masonic Cancer Center and Medical Center Minneapolis - Minneapolis

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2023-10-18
Est. Completion 2026-07
Phase Phase 3
RHEACELL GmbH & Co. KG

3 total trials

What the registry record for NCT05838092 still lists

NCT05838092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05838092 reports a single indexed study location in Colorado, Minnesota.

Frequently Asked Questions

What is clinical trial NCT05838092 about?

NCT05838092 is a clinical study titled "Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)". The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and...

What is the current status of trial NCT05838092?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2023-10-18. Estimated completion is 2026-07.

What conditions does trial NCT05838092 study?

This clinical trial studies the following conditions: Epidermolysis Bullosa.

What interventions are being tested in trial NCT05838092?

The interventions under investigation include: Placebo (DRUG), allo-APZ2-OTS (DRUG).

Who is sponsoring clinical trial NCT05838092?

This trial is sponsored by RHEACELL GmbH & Co. KG, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05838092 being conducted?

This trial has 2 study locations across Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Epidermolysis Bullosa

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05838092's enrollment target sits among peer trials

9 9th of 10 higher than 2 of 10 other Epidermolysis Bullosa trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Epidermolysis Bullosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05838092, the US trial registry maintained by the National Library of Medicine. NCT05838092 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.