Feature | April 18, 2014

Long-Term Outcomes From Cytori Cell Therapy Trial for Heart Failure Published in American Heart Journal

PRECISE data demonstrate sustained safety and benefit at 18 months

Cytori Stem Cell Therapy Heart Failure Treatments PRECISE Trial

April 18, 2014 — Cytori Therapeutics announced publication of safety and efficacy data from a 36 month European clinical trial of Cytori Cell Therapy in patients with chronic ischemic heart failure. Final data from the company’s PRECISE trial, a 27-patient, prospective, randomized, double-blind, placebo-controlled, feasibility trial (Phase I/IIA), demonstrated statistically significant differences in cardiac functional capacity between treated and placebo groups and will appear in an upcoming issue of the American Heart Journal. Cytori Cell Therapy is a mixed population of adipose derived regenerative cells (ADRCs) extracted from a patient’s own adipose tissue using Cytori’s proprietary Celution System.

“The PRECISE trial is the first-in-man trial involving the myocardial injection of ADRCs for heart disease,” said Dr. Emerson Perin, co-Principal investigator of the trial. “By demonstrating a strong safety profile and suggesting that the use ADRCs may preserve functional capacity, the data indicates that this therapy may have meaningful impacts on the lives of these very sick patients.”

The publication, co-authored by trial investigators Drs. Emerson C. Perin at Texas Heart Institute, Francisco Fernández-Avilés at Hospital Universitario Gregorio Marañón and others, reported that the procedure was safe, feasible and showed indications of a favorable benefit to risk profile. The study demonstrated that fat harvest through liposuction could be performed safely in cardiac patients. Exercise capacity as reflected by maximum oxygen consumption (MVO2) during treadmill testing, a reflection of cardiac functional capacity, was sustained in the ADRC treated group but declined in the placebo group at six and 18 months. Statistically significant differences were observed between the two groups.

“These results supported the design of the ongoing U.S. Phase II ATHENA trial that is evaluating a similar patient population,” said Steven Kesten, M.D., chief medical officer for Cytori. “We are encouraged by the sustained effects in functional endpoints, particularly MVO2, which is a relevant clinical endpoint in heart disease, and is an aid in directing treatment options, such as assist devices or heart transplant. We look forward to reporting the initial six-month results from the ATHENA trial.”

In addition, the data trends suggest that ADRC therapy may have a modest beneficial effect in scar stabilization. Left ventricular infarcted mass, the size of the scar tissue caused by lack of oxygen, remained consistent in ADRC-treated patients at six months compared to an increase in control patients, suggesting that ADRCs may prevent scar tissue from increasing. Other endpoints such as ventricular volumes and ejection fraction showed inconsistent findings.

In the PRECISE trial, all patients were treated with standard-of-care and subsequently underwent a liposuction procedure. Each patient’s adipose tissue was processed using Cytori’s proprietary Celution System to prepare the cell therapy. Cells (n=21) or placebo (n=6) were injected into areas of the heart muscle that were severely damaged but still viable and reversible using the NOGA XP System.

Cytori is currently enrolling patients in the U.S. ATHENA and ATHENA II trials, both 45 patient prospective, randomized, double-blind, placebo-controlled trials investigating a lower and a higher dose, respectively, of Cytori Cell Therapy in a similar patient population as PRECISE. In addition, Cytori has received a CE mark for the Intravase reagent to be used with the Celution System for intravascular delivery. The Intravase CE mark allows for targeted sales to physicians conducting independent research for intravascular indications. Cytori has a global patent estate related to the treatment of heart disease that includes 48 patents with 521 claims across 28 countries, including multiple countries in Europe, major Asian markets such as Japan and China, as well as other emerging markets.

For more information: www.cytori.com

Related Content

cardiac surgery, simulation training, University of Washington, case studies

Multiple repetitions of bypass grafts on a heart, using the Ramphal simulator. Courtesy of the University of Washington in Seattle.

News | Cardiovascular Surgery| August 25, 2016
August 25, 2016 — Simulation training fo
aortic dissection, family history, same age, clinical study, John A. Elefteriades, Annals of Thoracic Surgery
News | Structural Heart| August 25, 2016
People with a family member who had an aortic dissection — a spontaneous tear in one of the body’s main arteries —...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
nanoparticles, blood clotting, internal bleeding, American Chemical Society study, Erin B. Lavik

Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. Image courtesy of Erin Lavik, Ph.D.

News | Hemostasis Management| August 24, 2016
August 24, 2016 — Whether severe trauma occurs on the battlefield or the highway, saving lives often comes down to...
News | Heart Failure| August 23, 2016
August 23, 2016 — A new study of more than 13,000 people has found that so-called morbid obesity appears to stand alo
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
warfarin, long-term stability, atrial fibrillation, DCRI study, Sean Pokorney
News | Antiplatelet and Anticoagulation Therapies| August 16, 2016
August 16, 2016 — Warfarin prescribed to prevent strokes in...
Cardiovascular Systems Inc., LIBERTY 360 study, Amputation Prevention Symposium, PAD, peripheral artery disease, atherectomy
News | Peripheral Arterial Disease (PAD)| August 16, 2016
August 16, 2016 — Cardiovascular Systems Inc.
Overlay Init