News | September 04, 2014

Cytori Technology Selected for NHLBI Trial in LVAD Patients

stem cells, cytori, stem cell therapy

A stem cell

September 4, 2014 – The Cardiovascular Cell Therapy Research Network (CCTRN), has selected Cytori Therapeutics, Inc. to supply adipose-derived regenerative cells (ADRCs) for a clinical trial aimed at evaluating the safety and feasibility of treating patients with Left Ventricular Assist Devices (LVADs). The CCTRN is supported by grants from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). This trial, named CELLVAD-ADRC, will explore outcomes following administration of a regenerative cell preparation from adipose tissue into the patient’s heart muscle 60 to 90 days after placement of an LVAD. 
 
"Cytori is honored to have been selected by the CCTRN to collaborate on this trial. The CELLVAD-ADRC trial is consistent with our commitment to developing cell therapies for heart failure,” said Marc H. Hedrick, President and CEO of Cytori Therapeutics. “We look forward to understanding how ADRCs may benefit patients with a more advanced stage of heart failure than those being treated in our U.S. ATHENA trial.” 
 
CELLVAD-ADRC is a prospective, phase I, double-blind, randomized trial that will enroll 34 patients with end-stage ischemic heart disease who have received an LVAD in the preceding 60 to 90 days. Following an open-label phase where the initial 10 patients will all receive cell therapy subject to a safety committee review, 24 patients will be randomized 1:1 to receive either ADRCs or a placebo.
 
The trial will assess safety and feasibility endpoints including adverse events, cardiac function, exercise tolerance, myocardial viability and perfusion, and quality of life over a one year follow-up period. The trial is funded by the NHLBI through its Cardiovascular Cell Therapy Research Network (CCTRN), which will oversee trial design, implementation, and enrollment across its network of seven U.S. trial sites, which lead the field of cardiovascular cell therapy. 
 
Cytori Cell Therapy is a mixed population of autologous adipose-derived regenerative cells (ADRCs) extracted using Cytori’s innovative and proprietary Celution® System, creating new treatment opportunities for currently unmet medical needs. Adipose tissue is the richest source of stem and regenerative cells in the body. LVADs are mechanical devices used in hearts too weak to pump blood throughout the body. They are commonly implanted in patients waiting for a transplant or who do not qualify for a transplant but need additional pumping support. 
 
According to the American Heart Association, there are approximately 5.1 million Americans currently living with heart failure. For patients with a more advanced condition of heart failure, Ventricular Assist Devices are sometimes an option. In 2010, more than 1,400 LVAD devices were implanted into patients in the U.S. alone. 
 
For more information: www.cytori.com

Related Content

ProxiCor Extracellular Matrix Reduces Complications, Readmissions Following Pericardial Reconstruction
News | Stem Cell Therapies | April 19, 2019
Aziyo Biologics Inc. announced the publication of results from its landmark RECON study in the Journal of...
FDA Releases Final Guidances on Regenerative Medicine Therapies
News | Stem Cell Therapies | March 04, 2019
The U.S. Food and Drug Administration (FDA) recently finalized two guidance documents regarding regenerative medicine...
Heart Muscle Cells Created From Stem Cells Beat in Sync
News | Stem Cell Therapies | February 01, 2019
A team of Rutgers scientists have taken an important step toward the goal of making diseased hearts heal themselves – a...
FDA Clamps Down on Unapproved Stem Cell Therapies
News | Stem Cell Therapies | December 20, 2018
December 20, 2018 — The U.S.
Secant Introduces First Synthetic Regenerative Cardiovascular Graft for CABG
News | Stem Cell Therapies | January 17, 2018
Secant Group, in partnership with its sister company SanaVita Medical, announced new technology to advance...
News | Stem Cell Therapies | October 24, 2017
October 24, 2017 — Roche and Ncardia have reached a broad licensing agreement whereby Roche and its affiliate compani
BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System
News | Stem Cell Therapies | September 26, 2017
BioCardia Inc. recently announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the...
New Jersey Researcher Exploring New Stem Cell Therapies for Heart Attacks
News | Stem Cell Therapies | August 04, 2017
In petri dishes in her campus laboratory at New Jersey Institute of Technology, Alice Lee is developing colonies of...

An example of porcine cartdiac stem cells. Photo from the University of Miami Miller School of Medicine.

 

News | Stem Cell Therapies | June 12, 2017
June 12, 2017 — Heart muscle is one of the least renewable tissues in the body, which is one of the reasons that hear
Overlay Init