Bone Marrow Stem Cell Infusion Following a Heart Attack
This study has been completed.
Sponsor:
Minneapolis Heart Institute Foundation
Collaborator:
Abbott Northwestern Hospital
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00268307
First received: December 20, 2005
Last updated: December 3, 2013
Last verified: December 2013
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Purpose
The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. It is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. The stem cells will be taken from bone marrow and then given back into the heart vessels.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by Minneapolis Heart Institute Foundation:
Primary Outcome Measures:
- Safety as measured by holter monitor, laboratory assessments, and cardiac MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | December 2005 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Detailed Description:
This protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with PTCA/stenting.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268307
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268307
Locations
| United States, Minnesota | |
| Minneapolis Heart Institute Foundation | |
| Minneapolis, Minnesota, United States, 55407 | |
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Abbott Northwestern Hospital
Investigators
| Principal Investigator: | Jay Traverse, MD | Minneapolis Heart Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Minneapolis Heart Institute Foundation |
| ClinicalTrials.gov Identifier: | NCT00268307 History of Changes |
| Other Study ID Numbers: | opt001 |
| Study First Received: | December 20, 2005 |
| Last Updated: | December 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Minneapolis Heart Institute Foundation:
|
Cell therapy |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 26, 2016