Munich, Germany, August 23, 2011/ B3C newswire / - The Munich biotech company 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.
Causes and treatment options for pAOD
Around 4.5 million people in Germany suffer from peripheral arterial occlusive disease. (2) The most common cause of pAOD is "hardening of the arteries", arteriosclerosis. Since the illness is often not diagnosed in time, if at all, the consequences for those affected can be fatal: 75% of pAOD patients die of heart attack and stroke.(3) Peripheral arterial occlusive disease is one of the most common chronic diseases and is still increasing, particularly in the industrialised countries. Those affected suffer from progressive narrowing or even complete occlusion of major and minor blood vessels that supply the limbs with blood. The treatment options for pAOD include bypass surgery, angioplasty and, in severe cases, amputation of the foot and leg.
Adult stem cells offer hope
Due to the complexity of pAOD many patients cannot be healed with the current treatment approaches. "That's why stem cell-based treatment offers patients with advanced pAOD a highly promising alternative to stimulate the growth of new blood vessels and tissue regeneration", explained apceth's CEO Dr Christine Günther. In turn, this should increase the blood supply to the affected leg and promote healing of the chronic ischaemic wounds associated with pAOD. "We are proud that we have already started clinical trials on our first cell therapy product", said Dr Christine Günther.
Course of the study
As part of the clinical study on pAOD 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 pAOD", explained Christine Günther.
Adult stem cell therapy
Adult mesenchymal stem cells possess a broad spectrum of biological properties that are based on the natural healing powers of the organism. For instance, stem cells are capable of regenerating tissue and promoting wound healing. Another characteristic of these adult mesenchymal stem cells is that they do not trigger a reaction by the immune system, but instead regulate this system so as to dampen inflammatory processes. For this reason adult stem cells are suitable for autologous (body's own tissue) use, but also for allogeneic applications (the stem cell donor and the recipient of the cells are different individuals). In both cases there are no rejection phenomena such as those known in standard transplantation medicine.
apceth was founded in 2007 as a startup company with funding from a private investor with many years' experience in the pharmaceutical sector. The research work is centred on the development and clinical application of innovative stem cell and gene therapies for the treatment of benign and malignant diseases. apceth combines the principles of stem cell biology with innovative technologies on the basis of GMP-compliant propagation of stem cells and the latest findings in gene technology. apceth's primary aim is to develop innovative cell therapeutics for the treatment of clinical conditions and diseases for which no satisfactory treatment options have been available to date. Together with its partners, the Fraunhofer Institut and the LMU and TU in Munich, apceth is continually expanding its network to develop forward-looking cell therapeutics and push ahead with the clinical implementation of innovative therapeutic concepts. apceth is among the first companies in Germany to be granted a manufacturer's licence for the production of somatic cell therapeutics pursuant to Section 13, German Medicines Act.
apceth currently employs 35 members of staff. CEO Dr Christine Günther is an experienced physician in the field of stem cells and cell therapy and is also the Qualified Person. Nine of the team members are highly qualified scientists who are backed up by experienced technical assistants. Certified external partners work closely together with the apceth team.
Dr Christine Günther
Max-Lebsche Platz 30
Tel. : +49 (0)89 7009608 - 0
Fax : +49 (0)89 7009608 - 79
(1) Insertion of a catheter that is guided from the groin to the site of narrowing of the artery and then inflated with pressure.
(2) German Gesellschaft für Angiologie (DGA) [Society for Angiology]: "Verschlusssache PAVK – Was ist PAVK?" [Cause of pAOD - what is pAOD?], 2010.
(3) Deutsche Gesellschaft für Angiologie (DGA): "Bundesweiter 'Aktionstag Gefäßgesundheit'" [Nationwide German Campaign Day for Vascular Health], 2011.