Cardiac Muscle Repair

CardioCel™ is a product candidate that uses “off-the-shelf” MSCs to regenerate damaged or diseased heart muscle. It is targeted primarily to post-myocardial infarct patients. Osiris has demonstrated robust engraftment and cardiac differentiation of allogeneic MSCs in both pig and mouse infarction models. Delivery of allogeneic porcine MSCs improved left ventricular function in a reperfusion infarct model. Clinical trials are anticipated for early 2002.

Bone Regeneration

The OsteoCel® product candidate combines off-the-shelf human MSCs with an appropriate biocompatible matrix to regenerate bone that has been injured, diseased or degenerated. The figure illustrates critical gap repair in a baboon model, using allogeneic baboon MSCs on a supporting matrix. A Phase I clinical trial is underway and Phase II trials are planned for early 2002. Osiris seeks to address not only segmental gap cases, but also smaller non-unions, cavitary defects, spinal repair and craniofacial reconstruction.

Joint Repair

Chondrogen™ is a product candidate comprising off-the-shelf human MSCs delivered in liquid suspension by intra-articular injection. The aim is to regenerate a severely damaged meniscus, thus delaying or halting the progression of osteoarthritis in the knee joint. Osiris has established a goat model for the induction of osteoarthritis that includes a complete medial menisectomy. The figure shows the regeneration of the medial meniscus six weeks after a single intra-articular injection of 10 million allogeneic goat MSCs. Clinical trials are anticipated for early 2002.

Osiris develops off-the-shelf cellular products based on the human mesenchymal stem cell (hMSC). These products start with donor material that is expanded in vitro using Osiris' proprietary process. The expanded cells are cryopreserved in the undifferentiated stem cell state, shipped to and stored at the clinical site, then thawed for administration. Once delivered, the cells receive host signals that direct appropriate differentiation. Osiris' basic science and pre-clinical research have confirmed the ability to use MSCs in a fully allogeneic context without MHC matching or immunosuppression. Other clinical applications for hMSCs include support of hematopoietic stem cell transplantation (Phase II clinical trials).