Date: 2011-08-23
Type of information:
phase: 1-2
Announcement: initiation
Company: apceth (Germany)
Product: somatic cell therapy
Action mechanism: cell therapy
Disease: advanced peripheral arterial occlusive disease (pAOD) after angioplasty
Therapeutic area: Cardiovascular diseases
Country: Germany
Trial details: As part of the clinical study a small amount of bone marrow is first taken from the patients. The mesenchymal stem cells are isolated from the bone marrow sample and propagated as cell cultures under controlled conditions. The apceth team then prepares a purified and accurately defined fraction of the patient\'s own (autologous) stem cells for therapeutic use. These purified stem cells are available just a few weeks after taking the bone marrow sample and are then returned to the patient by intravenous infusion. (NCT01351610)
Latest news: apceth started its first phase I/II clinical study on somatic cell therapy for advanced peripheral arterial occlusive disease (pAOD) after angioplasty. The aim is to investigate the tolerability and efficacy of somatic cell therapeutics developed by apceth for the treatment of pAOD. The study is designed as an open, randomised, monocentre study with two parallel patient groups and is being conducted in cooperation with the Isar-Medizinzentrum in Munich. The first patients have already been treated. A total of 30 patients are to be recruited into the study by March 2012. The initial results of the study are expected by mid 2012.
