UW Hospital and Clinics is one of 15-20 research sites nationwide participating in the study, which is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corporation. Baxter technology is used to select the subject's own CD34+ stem cells that are under investigation in this trial.
The first step in the ACT34-CMI trial is to establish the baseline of how often the study subjects have chest pain related to their heart disease and the severity of the pain. Next, all subjects receive a series of needle shots, typically delivered under the skin in the arm, thigh or abdomen of a commercially produced protein (granulocyte colony stimulating factor). The protein helps to release blood-forming CD34+ cells from a subject's bone marrow into the bloodstream.
Then, investigators use a cell separation system to remove from the subject's bloodstream a mix of cells containing the stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells to select the CD34+ stem cells for use in this investigational therapy.
UW Health interventional cardiologists then "map" the heart with a catheter-based, non-surgical system to identify regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter system to deliver either CD34+ cells or placebo into areas of the heart that have poor blood flow. Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Subjects will receive follow-up examinations for 12 months following the investigative procedure.
"The initial results from Phase I of the trial we
Source:University of Wisconsin-Madison