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Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD

NCT03339973 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-29

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 Peripheral Arterial Occlusive Disease-related clinically relevant ulcers) and safety (by monitoring adverse events) of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive Disease.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

BIOLOGICAL

allo-APZ2-PAOD

Suspension of ABCB5-positive mesenchymal stem cells in pre-filled syringe

DRUG

Placebo

Solution for injection in pre-filled syringe

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

  • Oliver Müller, Prof. Dr. · Christian-Albrechts-Universität zu Kiel, Klinik für Innere Medizin III Kardiologie, Angiologie und internistische Intensivmedizin, Kiel, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2020-05-15
Completion
2020-05-15

Countries

  • Austria
  • Czechia
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03339973 on ClinicalTrials.gov