Next to the cardiac applications of bone marrow-derived progenitor cells, there is sound evidence that the same principles of inducing neovascularization and repair processes also apply to peripheral vascular diseases.
t2cure plans to initiate a pivotal clinical study in the orphan disease thromboangiitis obliterans (TAO), also called Buerger's disease. TAO is characterized by acute inflammation and non-atherosclerotic occlusion of the veins and arteries of the extremities, resulting in reduced blood flow to these areas. TAO typically occurs in young smokers, the exact cause is not yet known. Main symptoms are severe pain at rest, ulcers of toes, feet or finger which may finally lead to amputation.
t2cure’s bone marrow-derived cellular therapeutic received orphan drug designation from the FDA and the European Commission.
A clinical proof-of-concept study - PROVASA - included patients suffering from peripheral artery occlusive disease and thromboangiitis obliterans. Encouraging results of the PROVASA study were published in 2011.