Intermittent claudication: Can a novel cell therapy keep you moving?
March 8th, 2018
Severe arterial occlusive disease is a condition, in which the arterial circulation of limbs, usually the legs, decreases or is completely interrupted. After short physical activity, those affected suffer from pain due to lack of oxygen (ischemia). They limp and often stop in front of shop windows until the pain subsides to avoid attracting attention from others. Severe forms lead to non-healing wounds and even amputation of toes, feet or entire legs and are associated with high mortality. Factors such as smoking, diabetes, high blood pressure or disorders of the lipid metabolism increase the likelihood of getting this disease. The current treatment options are limited and the outcomes unsatisfactory: In more than 40 percent of patients, the affected tissue must be amputated within a year – about 70 percent of those suffering from a severe arterial occlusive disease die within ten years.
The clinical multi-center, randomized, international phase III study PACE promises an improved therapy, lowering mortality, avoiding amputations of the respective tissue and increasing quality of life. The researchers involved treat patients with a novel, exogenous PLacenta-eXpanded stromal cell product (PLX-PAD), which was developed by the cooperation partner Pluristem. "Our aim is to test the efficacy of multiple, intramuscular injections of PLX-PAD cell products for treatment," explains project coordinator Professor Hans-Dieter Volk, a clinical immunologist and the director at the BCRT. Due to the high medical need, this novel treatment option is one of the first to be included in a new regulatory approach by the European Medicines Agency (EMA) to ensure a timely approval process (Adaptive pathways), meaning that patients can be treated immediately after successful completion of this study.
PACE partners are world leaders with recognized expertise in scalable 3D clinical cell manufacturing, preclinical and clinical cell therapy, and biomarker analysis: Charité - Universitätsmedizin Berlin (Germany), Asklepios Kliniken Hamburg GmbH (Germany), Technische Universität Dresden (Germany), Medizinische Privatuniversität Paracelsus Salzburg - Privatstiftung (Austria), Pluristem Ltd (Israel), ICON Clinical Research Limited (Ireland), Genome Identification Diagnostics GmbH (Germany) and Ricerca e Sviluppo in Biotechnology Srlu (Italy). Professor Hans-Dieter Volk is responsible for coordinating the study. The study is made possible by research funding from the EU's Horizon 2020 programme amounting to €7.6 million.