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Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans"

NCT03267784 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

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 surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of two doses of the allogeneic investigational medicinal product "allo-APZ2-DFU" topically administered to the wound matrix of patients with diabetic neuropathic ulcer.

Conditions

  • Diabetic Neuropathic Ulcer

Interventions

BIOLOGICAL

allo-APZ2-DFU

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, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2020-06-29
Completion
2020-06-29

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 NCT03267784 on ClinicalTrials.gov