Clinical trial NCT01556022: Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
Official title: Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Ischemia
Keywords: Ischemic heart disease
Coronary artery disease
Chronic heart failure
Cardiovascular disease
Adult stem cells
Adipose derived regenerative cells
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.

Detailed description: To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.

Eligibility criteria: Key Inclusion Criteria:

1. Males or females 20-80 years of age
2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
3. CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
4. On maximal medical therapy for anginal symptoms and or heart failure symptoms
5. Hemodynamic stability (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate \< 110; Pulse-Oxygen \> 95)
6. Ejection fraction ≤ 45
7. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus

Key Exclusion Criteria:

1. Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
2. Unstable angina
3. LV thrombus, as documented by echocardiography
4. Planned staged treatment of CAD or other intervention on the heart
5. Platelet count \< 100,000/mm3
6. WBC \< 2,000/mm3
7. TIA or stroke within 90 days prior to randomization
8. ICD shock within 30 days of randomization
9. Any condition requiring immunosuppressive medication
10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 60 days prior to randomization
11. Revascularization within 60 days prior to randomization
12. Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
13. Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and /or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal range (x ULN) prior to randomization

Primary outcomes:
measure: Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
timeFrame: 6 and 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic - Torrey Pines, Scripps Green Hospital
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Florida Hospital-Pepin Heart Institute
state: Florida
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care
state: Utah
Study officials:
affiliation: Texas Heart Institute, Houston, TX
name: Emerson Perin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Heart Institute Foundation, Minneapolis, MN
name: Timothy Henry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry TD, Pepine CJ, Lambert CR, Traverse JH, Schatz R, Costa M, Povsic TJ, David Anderson R, Willerson JT, Kesten S, Perin EC. The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction. Catheter Cardiovasc Interv. 2017 Feb 1;89(2):169-177. doi: 10.1002/ccd.26601. Epub 2016 Sep 23.