A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/7/2018 |
| Start Date: | June 2015 |
| End Date: | August 2019 |
| Contact: | Anthony Ting, PhD |
| Email: | tting@athersys.com |
| Phone: | 216-431-9900 |
A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility
of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
Inclusion Criteria:
- Subjects of either gender, 18-85 years of age, inclusive
- Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
- Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%
Exclusion Criteria:
- Previous Coronary Artery Bypass Graft (CABG)
- Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
- Previous solid organ transplant
- Anticipated need for additional planned coronary revascularization procedure(s)
- Hemodynamic instability
- Mechanical complications of the index acute myocardial infarction
We found this trial at
11
sites
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