Trials / Completed
CompletedNCT01652209
To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.
A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Pharmicell Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are the primary targets of the drug, long term efficacy in the improvement of the left ventricle ejection fraction upon the first cell treatment is to be evaluated and compared with the current existing treatments (contemporary drug treatment). This study will also compare the efficacy and safety of single dose of hearticellgram-AMI.
Detailed description
We are enrolling a patient who had successful conventional percutaneous coronary intervention after acute myocardial infarction. Patients are allocated to one of three groups (group1=comparator, group2= one dose of hearticellgram-AMI). single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hearticellgram-AMI |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2024-08-12
- Completion
- 2024-08-12
- First posted
- 2012-07-27
- Last updated
- 2026-02-09
Locations
10 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01652209. Inclusion in this directory is not an endorsement.