About Cellular Therapy and Ixmyelocel-T
Ixmyelocel-T is a patient-specific, expanded multicellular therapy, manufactured using Aastrom’s proprietary, highly automated, fully closed cell-processing system. Aastrom’s patent-protected technology selectively expands mesenchymal cells, monocytes and alternatively activated macrophages, up to several hundred times more than the number found in the patient’s bone marrow, while retaining many of the hematopoietic cells collected from only a small sample (50ml) of the patient’s bone marrow. Below is a graphic illustrating Aastrom’s cell expansion process.
Advantages of Using Patient Bone Marrow
& Ixmyelocel-T in Treating Severe and Chronic Disease
Ixmyelocel-T has several features that are critical for success in treating patients suffering from a complex, multi-factorial, severe and chronic diseases such as dilated cardiomyopathy (DCM) or critical limb ischemia (CLI).
- Patient-specific (autologous): We start with the patient’s own cells, which are accepted by the patient’s immune system, allowing the cells to differentiate and integrate into existing tissues. This characteristic of our therapy, we believe, eliminates both the risk of rejection and the risk of having to use immunosuppressive therapy pre- or post-therapy. Our data also suggests that ixmyelocel-T provides the potential for long-term engraftment and repair.
- Expanded: We begin with a small amount of bone marrow from a patient (approximately 50ml) and significantly expand the number of certain cell types, primarily CD90+ mesenchymal cells, CD14+ monocytes and alternatively activated macrophages to far more than are present in the patient’s own bone marrow (up to 300 times the number of these cells compared with the starting bone marrow).
- Multicellular: We believe the multiple cell types in ixmyelocel-T, which are normally found in bone marrow but in different quantities, possess several functions required for tissue remodeling, immuno-modulation and the promotion of angiogenesis.
- Minimally invasive: Our aspiration procedure for taking bone marrow can be performed in an outpatient setting and takes approximately 15 minutes. For diseases such as CLI, the administration of ixmyelocel-T is also performed in an outpatient setting in a single procedure lasting approximately 20 minutes.
- Safe: Bone marrow and bone marrow–like therapies have been used safely and efficaciously in medicine for over three decades. Ixmyelocel-T leverages this body of scientific study and medical experience. Further, of the nearly 200 patients who have been treated in recent clinical trials (over 400 patients safely treated since inception), There appears to be no safety issues associated with ixmyelocel-T treatment.