Trials / Unknown
UnknownNCT03227198
IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- SCARM Institute, Tabriz, Iran · Other Government
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Intramyocardial injection of stem cell | 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) |
| BIOLOGICAL | Placebo | Injection of Placebo in patients with Heart failure in open heart surgery (CABG) |
Timeline
- Start date
- 2020-10-14
- Primary completion
- 2021-08-10
- Completion
- 2021-10-12
- First posted
- 2017-07-24
- Last updated
- 2020-10-27
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT03227198. Inclusion in this directory is not an endorsement.