NCT01556022

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

Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cytori Therapeutics · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-08-01
• Completion: 2016-10-01
• First posted: 2012-03-16
• Last updated: 2016-10-28

Locations

8 sites across 1 country: United States