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Status:

COMPLETED

Safety Study of Bone Marrow Derived Cells to Treat Damaged Heart Muscle

Lead Sponsor:

Neuronyx

Conditions:

Myocardial Infarction

Eligibility:

All Genders

30-75 years

Phase:

PHASE1

Brief Summary

Certain types of cells located in bone marrow may help the body recover after an injury. These cells may be able to help the body repair heart muscle that has been damaged from a heart attack. NX-CP10...

Detailed Description

Each patient will go through three phases during the study. The first is the screening/baseline phase, the second is the treatment phase, and the third is the follow-up phase. * The procedures that a...

Eligibility Criteria

Inclusion

  • 30-75 years of age (inclusive)
  • 30-60 days since AMI (defined as the most recent MI causing a doubling in cTnI enzyme concentrations relative to normal levels in addition to ECG changes consistent with MI with confirmation by myocardial perfusion imaging \[SPECT\])
  • Successful percutaneous revascularization restoring TIMI II or higher flow to infarcted area
  • Negative pregnancy test (serum βhCG) in women of childbearing potential (within 24 hours prior to dosing)
  • LVEF ≥ 30% as measured by myocardial perfusion imaging (SPECT)
  • Cardiac enzyme tests (CPK, CPK MB, cTnI) within the normal range at baseline
  • Willing and able to comply with protocol, including follow-up visits
  • Signed Subject Informed Consent Form

Exclusion

  • Significant coronary artery stenosis that may require percutaneous or surgical revascularization within six months of enrollment, as determined by the principal investigator
  • LV thrombus (mobile or mural)
  • High grade atrioventricular block (AVB)
  • Frequent, recurrent, sustained (\>30 seconds) or non-sustained ventricular tachycardia \> 48 hours after AMI
  • Clinically significant ECG abnormalities that may interfere with subject safety during the intracardiac mapping and injection procedure
  • Atrial fibrillation with uncontrolled heart rate
  • Severe valvular disease (e.g., aortic stenosis, mitral stenosis, severe valvular insufficiency requiring valve replacement)
  • History of heart valve replacement
  • Idiopathic cardiomyopathy
  • Severe peripheral vascular disease
  • Liver enzymes (aspartate aminotransferase \[AST\]/ alanine aminotransferase \[ALT\]) ≥ 3 times upper limit of normal (ULN)
  • Serum creatinine ≥ 2.0 mg/dL
  • History of active cancer within the preceding three years (with exception of basal cell carcinoma)
  • Previous bone marrow transplant
  • Known human immunodeficiency virus (HIV) infection
  • Evidence of concurrent infection or sepsis on chest X-ray (CXR) or blood culture
  • Participation in an experimental clinical trial within 30 days prior to enrollment
  • Alcohol or recreational drug abuse within six months prior to enrollment
  • Major surgical procedure or major trauma within the 14 days prior to enrollment
  • Known autoimmune disease (e.g., systemic lupus erythematosus \[SLE\], multiple sclerosis)
  • Clinically significant elevations in PT or PTT relative to laboratory norms
  • Thrombocytopenia (platelet count \< 50,000/mm3)
  • Inadequately controlled diabetes mellitus type I or type II, defined as a change in anti-diabetic medication regimen within the prior 3 months or HbA1C \> 7.0%
  • Uncontrolled hypertension defined as systolic blood pressure (SBP) \> 180 mmHg and/or diastolic blood pressure (DBP) \>100 mmHg
  • Use of ionotrophic drugs \> 24 hours post AMI
  • Other co-morbid conditions such as hemodynamic instability, unstable arrythmias, and intubation, which, in the opinion of the principal investigator, may place subjects at undue risk or interfere with the objectives of the study
  • Any other major illness, which, in the opinion of the principal investigator, may interfere with the subject's ability to comply with the protocol, compromise subject safety, or interfere with the interpretation of the study results

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00361855

Start Date

April 1 2006

Last Update

September 10 2008

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Arizona Heart Institute

Phoenix, Arizona, United States, 85006

2

Scripps Clinic

La Jolla, California, United States, 92037

3

Northwestern University

Chicago, Illinois, United States, 60611

4

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407