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Allogeneic ABCB5-positive Stem Cells for Treatment of CVU

NCT03257098 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-09-10

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the medicinal product to be studied after two applications on the wound surface in patients with Chronic Venous Ulcers.

Conditions

  • Skin Ulcer Venous Stasis Chronic

Interventions

BIOLOGICAL

allo-APZ2-CVU

Suspension of ABCB5-positive mesenchymal stem cells

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Ticeba GmbH

    collaborator INDUSTRY

  • Granzer Regulatory Consulting & Services

    collaborator OTHER

  • RHEACELL GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Andreas Kerstan, Dr. · Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2020-06-25
Completion
2020-06-25

Countries

  • Germany

Study Locations

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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 NCT03257098 on ClinicalTrials.gov