allo-APZ2-CVU-III
Research type
Research Study
Full title
A pivotal, randomized, placebo-controlled, double-blind, multicenter, international phase III clinical trial to investigate the efficacy and safety of allo-APZ2-CVU on wound healing of therapy-resistant non-healing chronic venous ulcers (CVU)
IRAS ID
1010063
Contact name
Anna Mößmer
Contact email
Sponsor organisation
RHEACELL GmbH & Co. KG
Eudract number
2024-512720-11
Clinicaltrials.gov Identifier
Research summary
Chronic venous leg ulcers are wounds that can develop in patients with chronic venous insufficiency, a condition in which the veins have problems sending blood from the legs back to the heart. Some patients with venous leg ulcers do not respond to standard treatments and develop non-healing wounds. These patients, despite the best treatment, have open wounds for a long time, which can be painful and reduce their quality of life. New treatments are urgently needed for these patients.
For this reason, this study is testing a new drug called allo-APZ2-CVU. The main purpose of this study is to see if the study drug is safe and efficient in patients with non-healing chronic venous leg ulcers. The study is a so-called phase III study. This means that the study drug was already tested in other studies and the results were promising.
The study will start at the end of 2024. Patients will be recruited over a 12-month period. This is an international clinical study conducted in multiple countries in the European Union, the United Kingdom and the United States.
The study is for adult patients with long-term, non-healing venous leg ulcers. In total, 250 patients will be included in the study.
Patients will be randomly divided into 2 groups. One group will receive the study drug, and the other group will receive placebo. The study drug consists of stem cells (ABCB5+ mesenchymal stromal cells), which have anti-inflammatory properties.
The study drug or placebo will be applied topically to the wound surface only once. During each subsequent study visit, wound healing will be monitored.
Upon randomization, patients will participate in the clinial trial for an overall period of 16 months.REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0232
Date of REC Opinion
9 Sep 2024
REC opinion
Further Information Favourable Opinion