Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramyocardial injection of stem cell | Experimental | Intramyocardial injection of autologous bone marrow mononuclear cells in patients with Heart Failure |
|
| Placebo | Placebo Comparator | Placebo intramyocardial injection in patients with Heart Failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramyocardial 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. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Safaie, CTS | Contact | 0413 33349525 | drsafaie@yahoo.com | |
| Peyman Keyhanvar, MD, Ph.D | Contact | 0413 33349525 | drkeyhanvar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nasser Safaie, CTS | Tabriz University of Medical Sciences | Study Director |
| Mohammad Nouri, Ph.D | Head of SCARM institute | Study Chair |
| Peyman Keyhanvar, MD, Ph.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cell And Regenerative Medicine institute (SCARM) | Tabriz | Iran |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Biological | Injection of Placebo in patients with Heart failure in open heart surgery (CABG) |
|
| 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 |
| 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 |