Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HL117572-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMI MultiStem cells | Experimental | AMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo. |
|
| Sham | Sham Comparator | Sham procedure using Micro-Infusion Catheter in coronary artery without injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMI MultiStem cells | Biological | AMI MultiStem cells administration in coronary artery with a micro-infusion catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects | 30 days |
| To assess the effects of AMI MultiStem therapy on cardiac function | To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effects of AMI MultiStem therapy on cardiac function | To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 365 |
| To assess the incidence of Major Adverse Cardiovascular Events (MACE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Penn, MD | Summa Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham | Other | Sham procedure using Micro-Infusion Catheter in coronary artery without injection. |
|
To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects |
| Day 365 |
| Incidence and severity of adverse events | To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects | Day 365 |
| Huntsville |
| Alabama |
| United States |
| Los Angeles | California | United States |
| Clearwater | Florida | United States |
| Gainesville | Florida | United States |
| Tampa | Florida | 33614 | United States |
| Detroit | Michigan | United States |
| Akron | Ohio | United States |
| Pittsburgh | Pennsylvania | United States |
| Salt Lake City | Utah | United States |
| Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided