Bone Marrow Stem Cell Infusion Following a Heart Attack

This study has been completed.
Sponsor:
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
  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
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

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:
No publications provided by Minneapolis Heart Institute Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014