CompletedNCT00933621Updated Jul 7, 2009

Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

A Phase 2 interventional study of Autologous bone marrow intracoronary infusion in Chronic Ischemic Symptomatic Heart Failure, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2009-07-07.

Sponsored by Assaf-Harofeh Medical Center · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years to 88 Years
Sex: All

Study summary

The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.

Read the detailed description

Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.

Conditions studied

Chronic Ischemic Symptomatic Heart Failure

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Heart Failure 5,701

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 8 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 88 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography

Exclusion criteria

Exclusion Criteria:

Idiopathic or non-ischemic cardiomyopathy
Other etiology for heart failure, history of past or current disease involving the bone marrow
Patients on dialysis
Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
Autologous Bone Marrow infusion
Percutaneous intracoronary autologous bone marrow infusion
Procedure: Autologous bone marrow intracoronary infusion

Interventions

ProcedureAutologous bone marrow intracoronary infusion
Percutaneous intracoronary mononuclear bone marrow cell infusion
Also known as: Intracoronary mononuclear bone marrow cell infusion

What researchers measure

Primary outcomes

Procedure success
Time frame: 9 months

Secondary outcomes

Functional class improvement
Time frame: 9 months

Study locations

1 site

Assaf Harofeh
Zerifin, 70300, Israel

References and documents

Publications

Murry CE, Reinecke H, Pabon LM. Regeneration gaps: observations on stem cells and cardiac repair. J Am Coll Cardiol. 2006 May 2;47(9):1777-85. doi: 10.1016/j.jacc.2006.02.002. Epub 2006 Apr 17. PubMed 16682301 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00933621
Lead sponsor: Assaf-Harofeh Medical Center
First posted: Jul 7, 2009
Start date: Apr 2003
Primary completion: May 2003
Completion: Dec 2003
Last update: Jul 7, 2009

Study contacts

Alex Blatt, MD

principal investigator · Assaf Harofeh MC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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