NCT03339973

Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD

A Randomised, Placebo-controlled, Double-blind, Interventional, Multicenter, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-PAOD for the Treatment of Peripheral Arterial Occlusive Disease (PAOD)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: RHEACELL GmbH & Co. KG · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an interventional, randomised, placebo-controlled, double-blind phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-PAOD for the treatment of Peripheral Arterial Occlusive Disease patients with non-healing ulcers. The allogeneic investigational product allo-APZ2-PAOD contains skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors and stored in a donor cell bank. Patients are followed up for efficacy for 12 weeks by clinical visits at the clinical trial sites to monitor wound healing. The wound healing process of all relevant ulcers will be documented by standardized photography and the quality of the wound healing process will be assessed. Pain will be assessed using a numerical rating scale and quality of life will be investigated with a standardized and validated questionnaire. To assess long-term safety of allo-APZ2-PAOD three follow-up visits at Months 6, 9 and 12 post IMP applications are included. An unblinded external Independent Data Monitoring Committee (IDMC) will continuously monitor safety throughout the study.

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
BIOLOGICAL	allo-APZ2-PAOD	Suspension of ABCB5-positive mesenchymal stem cells in pre-filled syringe
DRUG	Placebo	Solution for injection in pre-filled syringe

Timeline

• Start date: 2018-03-05
• Primary completion: 2020-05-15
• Completion: 2020-05-15
• First posted: 2017-11-13
• Last updated: 2020-06-29

Locations

18 sites across 5 countries: Austria, Czechia, Germany, Poland, United Kingdom