Stem Cell Clinical Trials

Cedars-Sinai Heart Institute is currently conducting the following Stem Cell Trials:

 

CADUCEUS:  CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dysfunction.
A Phase I Randomized, Dose Escalation Study of the Safety and Efficacy of Intracoronary Delivery of Cardiosphere-Derived Stem Cells in Patients With Ischemic Left Ventricular dysfunction and a recent Myocardial Infarction

Principal Investigators: Eduardo Marbán, MD, PhD; and Raj Makkar, MD

IRB Approval Number: 15079

Contact: Michelle Domingo (310)423-3875

Status: Long-Term Follow up

Summary: The purpose of this study is to determine whether giving cardiosphere-derived stem cells (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the heart.  In addition to determining whether this treatment is safe, the study will also examine whether it can decrease the amount of heart muscle damage and/or improve heart function after a heart attack. The amount of heart muscle damage and the function of the heart directly affect prognosis (the predicted course of the disease), and the development of heart failure and other complications some patients experience after a heart attack.
The type of study is called a prospective, randomized, dose escalation study. This means that some of the patients will receive a solution which contains the cells and some of the patients will receive conventional medical treatment. The ratio is 2:1, which means that twice as many patients will receive cells as will receive conventional medical treatment. The first 6 patients in each group will be randomized to receive the study drug at a dose of 12.5 million cells or conventional medical treatment. The remaining 18 patients will be randomized to receive study drug at a dose of 25 million cells or conventional medical treatment.


The Cellular Origin of Cardiospheres and Cardiosphere-derived Cells (putative adult resident cardiac stem cells).

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 12121

Contact: Michelle Domingo (310) 423-3875

Status: Enrolling

Summary: The purpose of this research study is to provide more information on a newly discovered type of heart stem-cells known as "cardiosphere" cells. It is not clear whether cardiosphere cells are intrinsic heart cells, or whether they "seed" into the heart from the circulation. This research will try to answer that question. Patients with a history of cardiac transplantation whose doctors recommend that they need a cardiac biopsy procedure can participate in this study.


Peritoneal Cavity Derived Stem Cells: A Pilot Study

Principal Investigator: PK Shah, MD

IRB Approval Number: 11388

Contact: Colleen Sam (310) 248-7651

Status: Enrolling

Summary: The purpose of this study is to determine the genotype and phenotype characteristics of peritoneal cavity derived cells to determine whether stem cells are present in human peritoneal cavity. Peritoneal lavage fluid from patients who undergo elective open abdomen or laparoscopic surgery will be collected for this purpose. Additional medical information will be collected from each patient. Patients who are scheduled to undergo elective open abdomen or laparoscopic surgery are eligible to participate.

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