Cytori Therapeutics has received approvals to initiate a clinical trial in Spain to investigate the use of adipose derived stem and regenerative cells for the treatment of cardiovascular disease.
The cells will be obtained at the bedside from the patients’ own adipose tissue, the richest source of adult stem cells, and made available in real-time using Cytori’s Celution™ stem and regenerative cell processing system. Patient enrollment will begin imminently.
According to Cytori, its trial, designated as the ‘PRECISE’ study, will primarily evaluate safety and feasibility in 36 patients with chronic ischemia, a severe form of coronary artery disease.
The Company’s Celution™ stem and regenerative cell processing system will extract and concentrate a patient’s cells in the catheterization suite so they are available for the physician to re-inject into damaged heart muscle in about an hour.
A variety of clinical functional and imaging endpoints will be assessed in the study. The outcomes of the study will be evaluated after a six-month follow up.
“We believe this study will be an important advance for patients with cardiovascular disease,” said Alex Milstein, Vice President, Clinical Development for Cytori Therapeutics.
“With this approval to begin our first company-sponsored clinical trial of the CelutionTM adipose stem and regenerative cell processing system, our clinical development timeline remains on track. We expect to present the six-month outcomes of this study in 2008.”