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This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracoronary injection of stem cell | Experimental | Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure |
|
| Placebo | Placebo Comparator | Placebo injection via coronary arteries in patients with Heart Failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary injection of stem cell | Biological | Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Death | The rate of patients mortality after transplantation | 12 months |
| Hospitalization | the rate of hospitalization after transplantation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction changes | Elevation of ejection fraction in patients after transplantation | 12 months |
| 6-minute walk test (6MWT) | Evaluation the improvement of 6MWT test after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Aslanabadi, MD, Cardiologist | Contact | 0413 33349525 | aslanabadin@yahoo.com | |
| Peyman Keyhanvar, MD, Ph.D | Contact | 0413 33349525 | drkeyhanvar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nasser Aslanabadi, MD, Cardiologist | Tabriz University of Medical Sciences | Study Director |
| Mohammad Nouri, Ph.D | Head of SCARM institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cell And Regenerative Medicine institute (SCARM) | Tabriz | Iran |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Placebo | Biological | Injection of Placebo in patients with Heart failure via coronary arteries |
|
| 12 months |
| Pro b-type natriuretic peptide (Pro-BNP) changes | Elevation the reduction of Pro-BNP in patients after transplantation | 12 months |
| NYHA functional class | Evaluation the improvement of NYHA functional class in patients | 12 months |
| Peyman Keyhanvar, MD, Ph.D |
| Deputy for translational medicine of SCARM institute |
| Principal Investigator |
| Raheleh Farahzadi, Ph.D | Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran | Principal Investigator |
| Yousef Faridvand, Ph.D | SCARM institute | Principal Investigator |
| Elgar Anamzadeh, MD, Cardiologist | Tabriz University of Medical Sciences | Principal Investigator |