Heart Disease

In the area of heart disease, Cytori is sponsoring three European clinical trials that evaluate the use of adipose-derived stem and regenerative cells (ADRCs) to treat acute myocardial infarction (heart attack) and chronic myocardial ischemia (a severe form of coronary artery disease).

Heart disease is the number one cause of death in the U.S., Europe, and the majority of other countries around the world. Advanced heart disease also accounts for many disabilities, lost productivity, and diminished lifestyle. Cytori performed pre-clinical (in the laboratory) studies that suggested a restoration of heart function following the application of adipose-derived stem and regenerative cells (ADRCs). Cytori is conducting two safety and feasibility trials, the APOLLO and PRECISE trials, in the areas of acute heart attack and chronic myocardial ischemia, respectively. Currently, Cytori is enrolling a pivotal European trial, ADVANCE, for acute myocardial infarction.       

ADVANCE
Acute Myocardial Infarction (heart attack)
>>Learn more on ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT01216995

Study Status: Enrollment is currently open. ADVANCE is a randomized, placebo controlled, double-blind trial that will enroll up to 370 patients with ST-elevation myocardial infarction at up to 35 centers, predominantly in Europe. The primary endpoint of the trial is reduction in infarct size as measured by cardiac magnetic resonance imaging (MRI). The ADVANCE trial will use the Celution® One, the next generation device manufactured by Olympus-Cytori Joint Venture.

APOLLO
Acute Myocardial Infarction (heart attack)
>>Learn more on ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT00442806

Study Status: Enrollment Complete/Patient follow-up ongoing. Cytori's APOLLO trial is a safety and feasibility study in Europe to evaluate the use of ADRCs as a treatment in heart attack patients. Within 24 hours of experiencing heart attack symptoms, a patient’s own ADRCs are extracted and injected into his/her coronary artery.

Enrollment is complete, and patients will be followed and evaluated for three years. The last patient enrolled in the study is expected to finish study participation by April of 2012.  6 month primary outcomes were reported in May 2010, with 18 month data reported in June 2011. This data will provide information on safety and feasibility of the use of ADRCs in this patient population.

PRECISE
Chronic Myocardial Ischemia (coronary artery disease)
>>Learn more on ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT00426868

Study Status: Enrollment Complete/Patient follow-up ongoing. Cytori's PRECISE trial is a safety and feasibility study in Europe to evaluate the use of ADRCs in chronic ischemia patients that cannot be treated with other means. A patient’s own ADRCs are extracted and then injected around the injured, oxygen-deprived areas of his/her heart through a catheter.

Enrollment is complete, and patients will be followed and evaluated for three years. The last patient enrolled in the study is expected to finish study participation by April of 2012.  6 month primary outcomes were reported in May 2010, with 18 month data reported in November 2010. This data will provide information on safety and feasibility of the use of ADRCs in this patient population.  

Apollo
The following sites are participating in the study: Thoraxcenter Erasmus Medical Center Hospital in Rotterdam, The Netherlands, and Hospital Universitario Gregorio Marañón in Madrid, Spain.

Precise
The following sites are participating in the study: Hospital Universitario Gregorio Marañón in Madrid, Spain, Thoraxcenter Erasmus Medical Center Hospital in Rotterdam, The Netherlands, University Medical Center in Utrecht, The Netherlands, and Rigshospitalet in Copenhagen, Denmark.