Trials / Completed
CompletedNCT02052427
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (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 efficacy clinical trial.
Detailed description
To assess the safety and efficacy 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Celution System | ADRCs processed by the Celution System for reintroduction into the myocardium |
| DEVICE | Placebo | Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-08-01
- Completion
- 2016-10-01
- First posted
- 2014-02-03
- Last updated
- 2016-10-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02052427. Inclusion in this directory is not an endorsement.