News | Stem Cell Therapies | May 16, 2016

Processed Fat Stem Cells Show Potential for Refractory Ischemia Patients

At one-year, patients more than 50 percent improved at least one NYHA class and angina class 

May 16,  2016 — Patients treated with processed autologous adipose-derived regenerative cells (ADRCs) injected into the heart muscle demonstrated symptomatic improvement and a trend towards lower rates of heart failure hospitalizations and angina, despite no improvement in left ventricle ejection fraction (LVEF) or ventricular volumes. The ATHENA trial results were presented as a late-breaking clinical trial at the 2016 Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting. 

ADRCs are a combination of cell types, such as adult stem cells, vascular endothelial cells, and vascular smooth muscle cells. Preclinical data indicates that these cells promote blood vessel growth, modulate inflammation and reduce cell death. These cells can be used in a variety of tissue types, including bone, cartilage, fat, skeletal muscle, smooth muscle and cardiac muscle. 

“ADRCs consist of multiple cell types with multiple potential benefits,” said Timothy D. Henry, M.D., MSCAI, director, division of cardiology at the Cedars-Sinai Heart Institute. Los Angeles, Calif., and the study’s lead investigator. “Based on the results seen with ADRCs in the PRECISE trial, we designed ATHENA to look at these cells as a possible treatment option for people with refractory chronic myocardial ischemia.” 

The phase 2 program was comprised of two prospective, randomized double-blind, placebo-controlled, parallel group trials (ATHENA and ATHENA II). The patients (average age 65 years) in each group (17 ADRCs, 14 placebo) were on the maximally tolerated medical management with an EF score of 20-45 percent. EF, the amount of blood pumped out of the ventricles with each contraction, can be an early indicator of heart failure if the score is 35 percent or below. The baseline average EF score for both groups was 31.6 percent. The patients were also CCS angina class II-IV and/or NYHA class II-III, had ongoing ischemia and multi-vessel cardiovascular disease, but were not candidates for revascularization. 
Using standard liposuction, a small volume of the patient’s fat tissue (<450 ml) was extracted and then the cells were separated from the tissue and concentrated (Celution System, Cytori Therapeutics, San Diego, Calif.) on-site. Following cell processing, the ADRCs were injected directly into the patient’s heart muscle. 

At the one-year mark, the ADRC treated patients with at least one class improvement in heart failure class (57 percent) and angina class (67 percent) tended to be higher relative to the placebo group (15 and 27 percent, respectively). Further, the cell-treated patients noted an improvement in the Minnesota Living with Heart Failure questionnaire (-21.6 vs. -5.5, p=0.038) and showed a trend toward relatively fewer heart failure hospitalizations (centrally adjudicated [2/17, 11.7 vs. 2/14, 21.4 percent]). There were no between group differences in LVEF or ventricular volume. 

Henry noted that while ATHENA observed a small patient population, the results are promising and consistent with what was seen with PRECISE and should provide the foundation for a large phase 3 trial. 

The study, designed to enroll 90 patients, was terminated prematurely due to three neurological events that prolonged trial enrollment, but were not cell related. 

Henry reported that he received modest support from Cytori Therapeutics, the sponsor of the trial.

For more information: www. SCAI.org/SCAI2016 

 

Related Content

Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
Overlay Init