NCT00268307

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

4.1 years

First QC Date

December 20, 2005

Last Update Submit

December 3, 2013

Conditions

Acute Myocardial Infarction

Keywords

Cell therapy

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by holter monitor, laboratory assessments, and cardiac MRI

    6 months

Secondary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

Cell therapy

EXPERIMENTAL

Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells.

Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells

Interventions

Autologous, Unfractionated Bone Marrow Mononuclear CellsDRUG

Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.

Cell therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (1)

  • Traverse JH, McKenna DH, Harvey K, Jorgenso BC, Olson RE, Bostrom N, Kadidlo D, Lesser JR, Jagadeesan V, Garberich R, Henry TD. Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction. Am Heart J. 2010 Sep;160(3):428-34. doi: 10.1016/j.ahj.2010.06.009.

    PMID: 20826249RESULT

Related Links

Study Officials

  • Jay Traverse, MD

    Minneapolis Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

December 1, 2005

Primary Completion

January 1, 2010

Study Completion

September 1, 2010

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations

US(1)