Trials / Unknown
UnknownNCT03145402
ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation 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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Intracoronary 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. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques. |
| BIOLOGICAL | Placebo | Injection of Placebo in patients with Heart failure via coronary arteries |
Timeline
- Start date
- 2020-10-20
- Primary completion
- 2021-08-28
- Completion
- 2021-10-02
- First posted
- 2017-05-09
- Last updated
- 2020-03-17
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT03145402. Inclusion in this directory is not an endorsement.