In the area of heart disease, Cytori is sponsoring two 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). With the APOLLO-01 and PRECISE-01 studies, Cytori hopes to discover that the use of ADRCs can lead to a reduction in disability and mortality.
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-01 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. Meanwhile, primary outcome data from six months of study participation for all patients will be analyzed in 2010. This data will provide information on safety and feasibility of the use of ADRCs in this patient population.
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-01 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. Meanwhile, data from six months of study participation for all patients will be analyzed in 2010. This data will provide information on safety and feasibility of the use of ADRCs in this patient population.