Bone Marrow Stem Cell Infusion Following a Heart Attack
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00268307 |
Recruitment Status :
Completed
First Posted : December 22, 2005
Last Update Posted : December 5, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Cell therapy
Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.
|
Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells
Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes. |
- Safety as measured by holter monitor, laboratory assessments, and cardiac MRI [ Time Frame: 6 months ]
- Improvement of left ventricular function as assessed by serial measurements of infarct size and LV function by cardiac MRI in the active treatment group versus placebo. [ Time Frame: 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients age at least 21 years of age
- Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm.
- Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting.
- Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography.
- Consent to protocol and agree to comply with all follow-up visits and studies.
Exclusion Criteria:
- History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD.
- Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis > 70% luminal obstruction in the non-infarct related vessel.
- History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ.
- History of anemia (Hb < 9.0 mg/dl).
- History of thrombocytosis.
- PT or PTT greater than the upper limits of normal.
- Life expectancy less than one year.
- Patients on chronic dialysis.
- History of untreated alcohol or drug abuse.
- Currently enrolled in another Investigational drug or device trial.
- History of stroke or TIA within the past 6 months.
- History of severe valvular heart disease (aortic valve area < 1.0 cm2 or > 3+ mitral regurgitation.
- Pregnancy
- Subjects who are HIV, hepatitis B or C positive.
- Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.
- Contraindications to cardiac MRI

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268307
United States, Minnesota | |
Minneapolis Heart Institute Foundation | |
Minneapolis, Minnesota, United States, 55407 |
Principal Investigator: | Jay Traverse, MD | Minneapolis Heart Institute |
Additional Information:
Publications of Results:
Responsible Party: | Minneapolis Heart Institute Foundation |
ClinicalTrials.gov Identifier: | NCT00268307 History of Changes |
Other Study ID Numbers: |
opt001 |
First Posted: | December 22, 2005 Key Record Dates |
Last Update Posted: | December 5, 2013 |
Last Verified: | December 2013 |
Cell therapy |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |