ATHENA: Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia

• Sponsor: Cytori Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01556022
• Collaborator: (none)
• Enrollment: 28
• Locations: 8
• Arms: 2
• Duration (Months): 52
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia	Device: ADRCs processed by the Celution System; Device: Placebo Comparator: Lactated Ringer's and Subject's Blood	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADRCs processed by the Celution System 400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.	Device: ADRCs processed by the Celution System; Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.; Other Names: ADRCs Intramyocardial injections
Placebo Comparator: Lactated Ringers and Subject's blood Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.	Device: Placebo Comparator: Lactated Ringer's and Subject's Blood; Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization [6 and 12 Months]

   Safety endpoints include: Treatment emergent SAEs Arrhythmia assessment via Holter monitoring MACE defined as cardiac death and hospitalization for heart failure Feasibility endpoints include: Change in mVO2 at 6 months Change in LVESV/LVEDV at 6 months Change in ejection fraction at 6 months Change in perfusion defect at 6 months Resource utilization Change in heart failure symptoms, angina, and quality of life through 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology, P.C.	Birmingham	Alabama	United States	35211
2	Scripps Clinic - Torrey Pines, Scripps Green Hospital	La Jolla	California	United States	92037
3	University of Florida	Gainesville	Florida	United States	32610
4	Florida Hospital-Pepin Heart Institute	Tampa	Florida	United States	33613
5	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
6	Duke University Hospital	Durham	North Carolina	United States	27705
7	Texas Heart Institute	Houston	Texas	United States	77030
8	University of Utah Health Care	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• Cytori Therapeutics

Investigators

• Principal Investigator: Emerson Perin, MD, PhD, Texas Heart Institute, Houston, TX
• Principal Investigator: Timothy Henry, MD, Minneapolis Heart Institute Foundation, Minneapolis, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cytori Therapeutics
• ClinicalTrials.gov Identifier: NCT01556022
• Other Study ID Numbers: The ATHENA Trial
• First Posted: Mar 16, 2012
• Last Update Posted: Oct 28, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Cytori Therapeutics: Ischemic heart disease; Coronary artery disease; Chronic heart failure; Cardiovascular disease; Adult stem cells; Adipose derived regenerative cells
• Additional relevant MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia

Study Results

No Results Posted as of Oct 28, 2016