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

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init