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Stem cell technology utilizes adipose cells to treat damaged heart tissue
Celution 800 device shown safe, feasible treatment for patients after MI.
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Although not currently approved for cardiac applications, two double blind, placebo-controlled studies testing the Celution 800 regenerative cell therapy have shown promising results that may open doors for its use in patients with acute MI and chronic myocardial ischemia.
The Celution 800 technology (Cytori Therapeutics) is an adipose-derived regenerative cell therapy that involves a process of withdrawing fat tissue, separating out the regenerative cells and re-injecting the cells into the patient’s heart, all of which can be performed at the patient’s bedside.
“You can get [stem] cells in large numbers with far higher purity [from adipose tissue] than from other sources and with minimal morbidity,” John Fraser, PhD, principal scientist at Cytori and co-inventor of the technology, said in an interview. “This changes the approach from what people had been using, which were cell culture-based approaches where you’d extract bone marrow and spend several weeks growing the cells up. Now, physicians can just harvest and administer the patient’s stem cells at the bedside in a single procedure without the need for culture.”
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Photo courtesy of: Cytori Therapeutics |
Cytori first began receiving orders from Europe and Asia for the system in February 2008, with the device now being sold in the growing international reconstructive surgery market.
The results of two recent clinical trials may help this technology make the transition to CV applications. One of the trials, named APOLLO, enrolled 14 patients who had been successfully treated for an acute MI. The data, which were presented in a poster at the American Heart Association Scientific Sessions 2010, showed that Celution 800 therapy was well tolerated in all patients and did not result in any adverse events.
“When I would first talk about this, people were concerned about doing liposuction on a patient who had just had a heart attack,” Fraser said. “We’ve demonstrated in the APPOLLO trial that this is safe and feasible.”
The second trial, called PRECISE, involved the Celution therapy in 27 patients with no-option chronic myocardial ischemia. The researchers found a statistically significant improvement in maximum oxygen consumption in the cell-treated group compared with the control group, which was first demonstrated at 6 months and then sustained at 18 months, as well as a statistically significant improvement in patients’ ability to perform physical activity.
“We believe the safety and feasibility data from these trials, particularly PRECISE, demonstrate statistically significant improvements in endpoints such as exercise capacity, maximum oxygen uptake and [metabolic equivalent values] that gives us support in moving to regulatory approvals, particularly as these are otherwise no option, or orphaned patients,” Fraser said. “We intend on moving along that path; though, of course, we will have different strategies in different regions.”
Also upcoming for Cytori is the company’s next-generation stem cell technology, Celution One. The device is similar to the 800 model, only faster and with a larger amount of tissue. This, Fraser said, has obvious advantages at the bedside, as the physician will be able to process greater amounts of tissue in less time. – by Brian Ellis