From CD&D

Cytori Therapeutics (San Diego) reported enrollment of the first two patients in a clinical trial using adipose-derived stem and regenerative cells in the treatment of heart attack using its device/cell treatment combination system.

In the trial, patients’ cells are made available using Cytori’s Celution System, a processing device that automates the separation and concentration of stem and regenerative cells within adipose tissue so they may be prepared for cryopreservation.

The company said that one patient has been enrolled in two trial centers, Hospital Universitario Gregorio Marañón (Madrid, Spain), and Thoraxcenter, Erasmus Medical Center (Rotterdam, the Netherlands).

Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown to increase blood flow in and around damaged and oxygen deprived tissues. Thus, Cytori says these cells have the potential to revolutionize the treatment of heart disease.

"Time is of the essence in the treatment of patients with heart attacks," said Prof. PW. Serruys, MD, PhD, principal investigator for the trial and head of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center. "The Celution System makes adipose-derived regenerative cells available in real-time and enables early treatment." And he said the system could limit or reverse heart damage caused by a heart attack.

"A major challenge in cardiovascular cell therapy is having a meaningful number of stem and regenerative cells," said Francisco Fernández-Avilés, chief of Department of Cardiology at Hospital Universitario Gregorio Marañón and an investigator for this APOLLO trial. "To date, we have treated a number of patients with chronic ischemia in Cytori’s PRECISE trial, and we are pleased that the Celution device has enabled us to administer a meaningful dose of their own cells in real-time."

The APOLLO trial is a 48-patient, randomized, placebo-controlled, dose escalation, safety and feasibility multi-center study. A dose of adipose-derived regenerative cells, or a placebo, will be delivered through an intracoronary catheter within 36 hours following the onset of a heart attack. The trial will involve four groups of 12 patients each. In each group, nine patients will receive cells and three will receive the placebo control.

In other news from Cytori, the company reported that Green Hospital Supply, Cytori’s StemSource commercialization partner for Japan, will purchase 2 million Cytori shares, paying $12 million for them. Green Hospital also will be granted a non-voting observer seat on Cytori’s board.

The transaction will close on or before Feb. 28, subject to customary conditions. Following the transaction, Green Hospital’s ownership in Cytori will increase to 3 million shares, representing 11.5% of Cytori’s total shares outstanding.

"Our increased equity position in Cytori is strategically important for our business," said Kunihisa Furukawa, resident of Green Hospital. "We have identified Cytori’s StemSource Cellbank product as one of the primary foundations of our future growth. In addition, we believe their vision, products and business model will create the global leader in regenerative medicine."

"This strategic equity agreement strengthens our commercialization partnership with Green Hospital Supply, who will play an instrumental role in our future success," said Calhoun. "Simultaneously this deal provides us with capital to invest in the development and commercialization of our Celution System."

The StemSource Cellbank is marketed in Japan for hospitals that wish to offer adult stem cell banking. The StemSource Cellbank will be commercialized to hospitals in Japan by Green Hospital, in partnership with Cytori. The foundation of the StemSource Cellbank is Cytori’s Celution System.