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Provacel · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Provacel: Cohort 1 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 2 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 3 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 4 | ACTIVE_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Placebo | PLACEBO_COMPARATOR | ex vivo cultured adult mesenchymal stem cells |
| Name | Type | Description |
|---|---|---|
| Provacel | BIOLOGICAL | ex vivo cultured adult mesenchymal stem cells |
| Placebo | BIOLOGICAL | Placebo |
Inclusion Criteria: * Male or female between 21 and 85 years old * First heart attack within 1 to 10 days Exclusion Criteria: * Positive for HIV 1 and 2 * Previous heart attack * Pacemaker or other device * Pregnant or breastfeeding * Allergic to cow or pig derived products * Previous bone marrow...
Provacel is an investigational cell therapy developed by Mesoblast Limited (ticker MESO) for the treatment of myocardial infarction, commonly known as a heart attack. It is being studied as a treatment for patients who have experienced acute myocardial infarction, and it remains in clinical development rather than being an approved product.
Provacel is being developed to treat acute myocardial infarction, the medical term for a heart attack. The clinical program has focused on patients aged 21 and older who have suffered an acute myocardial infarction, evaluating whether the cell therapy is safe in this population. It is investigational and not approved for use.
Provacel is developed by Mesoblast Limited, an Australian regenerative medicine company that trades under the ticker MESO. Mesoblast is the sponsor of the clinical program studying Provacel in cardiovascular disease.
Provacel is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency, and it remains an investigational cell therapy for myocardial infarction. The Phase 1 program has been completed, with no trials currently active.
Provacel has been studied in one completed clinical trial, NCT00114452, titled "Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction." The Phase 1 trial enrolled 60 participants in the United States, was randomized, double-blind, and placebo-controlled, and included patients aged 21 and older.
Provacel is a cell therapy, meaning it uses living cells as the active treatment rather than a conventional small molecule or protein drug. It was studied as a preparation of adult mesenchymal stem cells administered to patients after acute myocardial infarction, with the completed Phase 1 trial designed primarily to assess safety in that setting.