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RECRUITING Phase 2

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

NCT05157958 · View on ClinicalTrials.gov ↗

Study Summary

After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.

Interventions

  • OTHER Vehicle Control
  • BIOLOGICAL ALLO-ASC-SHEET

Study Locations (1)

Florida

  • University of Miami Dermatology Clinical Trials Unit — Miami

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2023-05-01
Est. Completion 2026-04-28
Phase Phase 2

Sponsor

Anterogen Co.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05157958

The ClinicalTrials.gov registry entry for NCT05157958 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anterogen Co., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 2 interventions — of which Vehicle Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05157958 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05157958 about?

NCT05157958 is a clinical study titled "Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa". After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the tim...

What is the current status of trial NCT05157958?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2023-05-01. Estimated completion is 2026-04-28.

What conditions does trial NCT05157958 study?

This clinical trial studies the following conditions: Dystrophic Epidermolysis Bullosa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05157958?

The interventions under investigation include: Vehicle Control (OTHER), ALLO-ASC-SHEET (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05157958?

This trial is sponsored by Anterogen Co., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05157958 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial