http://www.medgadget.com/archives/2010/05/adiposederived_stem_cells_show_promise_in_treatment_of_chronic_ischemia.html

San Diego, CA based Cytori Therapeutics has announced the results of their PRECISE trial, in which patients with severe cardiomyopathy were treated with autologous adipose-derived regenerative cells (ADRCs). The ADRCs were obtained using Cytori's Celution system (which we previously covered here at Medgadget; see below), and were then injected into each patient's heart. At six months after the procedure, patients had improved oxygen consumption and aerobic capacity when compared to the control group. The international 27 patient study, conducted at Hospital Universitario Gregorio Marañón (Madrid), Texas Heart Institute and Erasmus University Hospital, was just presented at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, Spain.

Conclusions from the study, via press release:

 

• Liposuction and cell injection were safe in these severely compromised patients, with no serious adverse events (arrhythmia or major adverse cardiac events)

• MVO2 showed a statistically significant improvement from baseline to six-months in the cell treated group as compared to placebo. MVO2 is a clinically relevant prognostic factor in heart disease and is commonly used as a contributing measure to stratify patients for heart transplant

• The results showed absolute increase (improvement) in MVO2 by 0.6 mL/kg/min in the treated group versus 2.8 mL/kg/min decrease (worsening) in the placebo group from baseline to six-months, based on matched-pair analysis. This difference was statistically significant (p < 0.05). This analysis excludes two patients whose follow up MVO2 results were not available

• For the entire cohort of patients, mean MVO2 improved from 16.6 mL/kg/min at baseline to 17.2 mL/kg/min at six-months in cell-treated patients, and worsened from 19.0 mL/kg/min to 15.5 mL/kg/min in the placebo group

• METS (metabolic equivalent), a measure of the patient's aerobic capacity, improved by 0.2 points from baseline to six-months in the cell treated group compared to a decrease of 0.8 points from baseline to follow up in the placebo group based on matched-pair analysis; the difference was statistically significant (p < 0.05)

• The percent of left ventricle infarcted, the portion of the heart not receiving blood to support pumping, decreased (improved) by 3.0% in the cell treated group compared to an increase (worsening) of 5.2% in the placebo group, an absolute difference of 8.2%

• Improvements in New York Heart Association Functional Class, which classifies the severity of heart disease on a scale of one to four, were observed in 63% of patients treated with cells as compared to observed in 33% of patients in the placebo group

May 12, 2010 (Medgadget.com)