Peripheral Arterial Occlusive Disease
Study Number: MSC_Apceth_001
EudraCT Number: 2010-021821-10
Status: Recruiting
Apceth started its first Clinical Trial Phase I/II for the treatment of advanced Peripheral Arterial Occlusive Disease (PAOD) in March 2011. The PAOD Clinical Trial is designed as an open, randomized, monocentric, two-parallel group trial. It is conducted in cooperation with the Isar Medical Centre in Munich (www.isarkliniken.de/cms/). The goal of the clinical trial is to investigate the tolerability and efficacy of Apceth cell therapeutics based on autologous mesenchymal stem cells in the treatment of advanced PAOD after angioplasty.
PAOD patients suffer from either a gradual narrowing or complete occlusion of large, small or very small arterial vessels supplying the extremities. PAOD is one of the most frequent and progressive chronic diseases which represents an increasing medical problem in Western societies. Cardiac infarction, stroke and PAOD are different manifestations of the same systemic vascular disease. PAOD can cause ischemic pain, walking difficulties, ulceration and gangrene. The curative options include vascular bypass surgery, angioplasty and in severe cases amputation of the affected foot or leg. Unfortunately, many patients cannot be cured with currently available treatment options because of the anatomical complexity of the disease and the presence of additional risk factors (such as diabetes). In such advanced PAOD cases stem cell therapies may provide a promising alternative treatment that is supposed to trigger neo-angiogenesis and tissue regeneration. This on the other hand may lead to increased blood supply into the limbs and promote healing of the chronic ischemic wounds which are associated with PAOD.
In the Apceth PAOD Clinical Trial a small amount of bone marrow is obtained by bone marrow aspiration from the patient. The mesenchymal stem cells (MSCs) are isolated from this bone marrow sample and propagated under controlled conditions in the cell culture. The final result is a pure and well defined stem cell fraction of the patient’s own (autologous) stem cells for therapeutic use. The cell fraction is available already a few weeks after the bone marrow donation. Such patient’s stem cells are returned to the patient via intravenous infusion.
In case you are a patient or physician seeking further information or consulting on the PAOD Clinical Trial we will be happy to talk to you in person. All information obtained from the patients will be treated strictly confidentially as a doctor-patient conversation and will be under no circumstances passed to third parties.
If you are a patient, please keep in mind that the contact with Apceth cannot replace medical consulting with your doctor. Only together with your doctor you will be able to gather the necessary information to consider all currently available therapeutic options and decide on the best medical treatment for you.
Contact person:
Dr. med. Christine Günther
| Tel: | +49 (0)89 7009608 - 25 |
| Mobil: | +49 (0)160 74 38 048 |
| eMail: | study001@apceth.com |