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Biological

RENEW: Efficacy and safety of target intramyocardial delivery of autologous CD34+ cells (Auto CD34+ cells) for the improvement in exercise capacity in subjects with refractory angina

Short Description: This study is an attempt to help patients with chronic angina by injecting stem cells taken from the patient into their heart muscle to help reduce the symptoms. These patients are typically not candidates for further heart surgery. There will be 3 groups in this study for a total of 444 subjects-two of which will be blinded to treatment. The first group will have approximately 222 subjects and will receive Auto-CD34+ stem cell. The second group will have 111 subjects and will receive placebo. The third group which is not blinded will have 111 subjects and will not receive an injection of either stem cells or placebo. The unblinded control group is used to better understand the safety of standard of care compared to the safety of being injected with stem cells or placebo. Upon eligibility confirmation patients will come to the study site and be randomized in one of the 3 treatment arms.

Principal Investigator: Warren Sherman, MD

http://www.clinicaltrials.gov/ct2/show/NCT01508910?term=RENEW&rank=3

 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 

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