Apceth has initiated the first Phase I/II clinical study of its somatic cell therapy for peripheral arterial occlusive disease after angioplasty. The study, being conducted in cooperation with Isar Medizin Zentrum in Munich, Germany, aims to evaluate the tolerability and efficacy of somatic cell therapeutics for the treatment of the disease.

The open and randomised study, will have two parallel patient groups. Around 30 patients will be recruited by March 2012 and the initial results are expected by the middle of that year.

As part of the clinical study, a small amount of bone marrow will be taken, from which the mesenchymal stem cells are isolated and propagated as cell cultures under controlled conditions to generate the patient’s own stem cells for therapeutic use.

Apceth CEO Christine Günther said: “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.”

The key regions in the PAOD clinical trials market are North America, Asia-Pacific, Europe, the Middle East & Africa, and South & Central America, among others. Asia-Pacific dominates the market with more than 30% of clinical trials conducted, as of December 2022.

In the country-wise analysis, the US has the highest number of peripheral artery occlusive disease clinical trials, as of December 2022. The Netherlands has the highest average patient enrollment in peripheral artery occlusive disease clinical trials, as of December 2022. 

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