Chicago clinical research study for subjects with poor blood flow in the heart

What? Injection of Autologous (subject’s own adult stem cells) CD34-Positive Cells for Neovascularization (improving circulation)and Symptom Relief in Subjects with Myocardial Ischemia and Left Ventricular Ejection Fraction <40%

Where? Participants receive care at Northwestern Memorial Hospital with one test taking place at Weatherhead PET Center at the University of Texas Medical School

Why? To evaluate the safety and possible effectiveness of injecting a subject’s own stem cells into the regions of the heart with poor blood flow.

How? The subject begins with a screening period, consisting of laboratory and cardiac tests. This is followed by a treatment phase  in which a series of injections of a drug called Neupogen are given to help the stem cells move from the bone marrow into the blood circulation.  After 5 days of injections, the stem cells are collected from the circulation through a process called apheresis. The next day, the stem cells will be injected into the subject’s heart during a cardiac catheterization.

When? The study requires an 8 week screening period, a 6-day treatment period, and a year of follow up which includes visits at 1 week post the procedure, then at 1, 3, 6, and 12 months.

Who may participate? Subjects must meet the following criteria:

1. Persons that are 21-80 years old, with New York Heart Association class II or III ischemic heart failure
2. Have attempted “best” cardiac medical therapy
3. Have a recent coronary angiogram  which showed blocked arteries in the heart that can’t be  “opened up” with an angioplasty or bypass surgery
4. Have an ejection fraction of <40%, and a BNP level >100pg/ml

Who may not participate? Persons may not participate if they meet the following criteria:

1. Those who have had a heart attack within 30 days
2. Those who have had a stroke or TIA within 60 days
3. Those who have New York Heart Association class IV heart failure
4. Those with severe aortic or mitral valve disease, or any other disease that could  be associated with a life expectancy of less than 1 year such as cancer, renal failure, COPD,  and liver disease

For more information:

Rita Vargos, RN, Clinical Nurse Research Coordinator
201 E. Huron Galter Pavilion 11-240 
Chicago, IL 60611
(312) 695-0006
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
NU IRB Study # STU00002516
Principal Investigator; Dr. Douglas Losordo