allo-APZ2-PAOD-II-01
Research type
Research Study
Full title
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 atrerial occlusive disease (PAOD)
IRAS ID
254272
Contact name
Nils Tappenbeck
Contact email
Sponsor organisation
RHEACELL GmbH & Co. KG
Eudract number
2017-000235-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
This clinical trial is a scientific research study on patients who have Peripheral Arterial Occlusive Disease (PAOD). PAOD is a chronic vascular disease in which the arteries supplying the extremities are narrowing or closing. The lack of blood supply can lead to non-healing wounds. In the worst case, a leg has to be amputated. The prerequisite for participating in the study is that all possibilities for improving blood circulation have already been exhausted in advance.
For this clinical trial, so-called stem cells will be obtained from skin tissue of healthy donors and then fed and grown in laboratory under special conditions. The medicine containing these special stem cells is called allo-APZ2-PAOD and this solution will then be administered to the participating patients in the muscle. allo-APZ2-PAOD should promote the formation of new blood vessels. This is intended to stimulate and accelerate the supply of blood to the foot and thus wound healing.
allo-APZ2-PAOD belongs to a group of drugs known as advanced therapy medicinal products. It is a medicinal product that is under clinical investigation. That means it is not yet approved by the authorities for the treatment. To date, it has never previously been used on humans.This is a clinical trial with a control group. That means the patients will receive allo-APZ2-PAOD or a solution without stem-cells, so-called placebo.
The aim of this clinical trial is to investigate the effectiveness and safety of one dose of the allo-APZ2-PAOD administered into the muscle of the lower leg of patients affected by PAOD. This will be achieved by monitoring the reduction in wound size of non-healing ulcers and by monitoring changes in patients’ health after administration of the medicine.Patients will be monitored for efficacy for 3 months and for safety by telephone for 12 months after administration of the medicine.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0531
Date of REC Opinion
10 Jul 2019
REC opinion
Further Information Favourable Opinion