The Munich biotech company Apceth started its first phase I/II clinical study on somatic cell therapy for advanced peripheral arterial occlusive disease after angioplasty, the company announced on 23 August 2011.
The aim is to investigate the tolerability and efficacy of somatic cell therapeutics developed by Apceth for the treatment of peripheral arterial occlusive disease. The study is designed as an open, randomised, single-centre study with two parallel patient groups and is being conducted in cooperation with the Isar-Medizinzentrum in Munich, Germany. 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.
Due to the complexity of peripheral arterial occlusive disease many patients cannot be healed with the current treatment approaches. “That is why stem cell-based treatment offers patients with advanced peripheral arterial occlusive disease a highly promising alternative to stimulate the growth of new blood vessels and tissue regeneration,” said Apceth’s CEO Christine Günther.
In turn, this should increase the blood supply to the affected leg and promote healing of the chronic ischaemic wounds associated with peripheral arterial occlusive disease.
As part of the clinical study on peripheral arterial occlusive disease 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.
“In this study we are documenting the results with regard to the regeneration of tissue and the blood supply. This enables us to draw conclusions about the efficacy and tolerability of stem cell therapy in peripheral arterial occlusive disease,” explained Günther.