Then, investigators use a cell separation system, similar to the automated systems that are used with people who donate specific blood components such as platelets or red blood cells, to collect from the subject's bloodstream, an enriched preparation of cells that contain CD34+ stem cells. When this process, known as apheresis, is complete, technologists further process the collected stem cells with Baxter's ISOLEX 300i Magnetic Cell Selection System, currently approved for use with cancer patients, to select the subject's CD34+ stem cells for use in this investigational therapy.

Schaer then uses a catheter-based, non-surgical system to map the patient's heart three-dimensionally to identify the damaged areas into which the stem cells would be injected. "This targeted approach increases the treatment's effectiveness by delivering the stem cells exactly where they are needed." Schaer uses the Johnson & Johnson's NOGA XP Cardiac Navigation System to identify ischemic but viable regions of the heart as targets for cell delivery. The researchers then use a special investigational catheter that functions like a "global positioning system" to precisely deliver CD34+ cells, or placebo, into the areas of the heart that have been identified as having poor blood flow.


Subjects are randomly selected to receive either one of two dosing levels of CD34+ stem cells, or placebo. Rush researchers will conduct follow-up examinations for 12 months,

Researchers are encouraged by reports that the therapy appeared to be well-tolerated and no serious adverse events directly related to the stem cell therapy in an earlier study. According to preliminary, anecdotal patient reports, 16 of the 24 total Phase I study subjects reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.

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