Baxter (BAX) initiates P3 Adult Stem Cell Clinical Trial for Chronic Cardiac Condition
BAX has initiated a P3 pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).
- CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.
The trial will enroll approximately 450 patients across 50 clinical sites in theUnited States, who will be randomized to 1 of 3 arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or un-blinded standard of care.
- The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment;
- Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.
After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue.
- Efficacy will be measured by a change in total exercise capacity during the 1st year following treatment and safety data will be collected for 2 years.
The Bottom Line: This trial is being initiated based on the P2 data, which indicated that injections of patients’ own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina. Stem cell processing will be conducted in GMP facilities in the US by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem. Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions. Also … CD 34+ cell, should offer some sense of validation to what NeoStem (Amex: NBS) are saying about Amorcyte. Recall that Amorcyte’s cells are bone marrow collected to preserve the CXCR4 receptor which allows the cell to home along the ischemic gradient where Baxter’s are mobilized using GCSF (taken from the blood). As such Baxter cells are “blind” but they don’t care as the cells are locally injected into the heart muscle with a NOGA catheter (vs. AMR-001 that is give in the infarct related artery where the cells home along the ischemic gradient to the peri-infarct zone) … 2 different approaches with same cell type. Recall also that Dr. Losordo (Now Baxter PI, then and now, leading KOL in the cardiology cell therapy space) published a paper this summer which showed that CD 34+ cells are among the most potent proliferators of angiogenesis.