Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Neuronyx
ClinicalTrials.gov Identifier:
NCT00361855
First received: August 7, 2006
Last updated: September 9, 2008
Last verified: September 2008
  Purpose

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-CP105 is a new investigational drug that is made up of these special types of bone marrow cells, which come from another person. NX-CP105 has not been approved for sale or general use by the Food and Drug Administration (FDA), and this study will be the first time that NX-CP105 is given to human beings.

This study is being conducted to see if there are any side effects associated with with NX-CP105 and whether NX-CP105 may help the body repair heart muscle that has been damaged from a heart attack. Three different doses of NX CP105 will be tested in this study, starting with the lowest dose first.

Patients who decided to participate in the study will have a heart catheterization procedure during which a narrow tube is inserted into an artery (type of blood vessel) in the groin and passed to the heart. A second narrow tube will be inserted into a vein (type of blood vessel) in the groin and passed to your heart. A device will be passed through the second tube. This device will be used to inject NX-CP105 cells directly into your heart muscle.


Condition Intervention Phase
Myocardial Infarction
Drug: NX-CP105
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Open Label Dose Escalation Study Evaluate The Safety Of a Single Escalating Dose Of NX-CP105 (Human Adult Bone Marrow Derived Somatic Cells [hABM-SC] Administered by Endomyocardial Injection To Cohorts Of Adults 30-60 Days Following Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Neuronyx:

Primary Outcome Measures:
  • Safety as measured by clinical laboratory values, vital signs,
  • ECG/holter monitoring, echocardiogram

Secondary Outcome Measures:
  • Efficacy as measured by cardiac output/pressure gradients, myocardial perfusion, viability and ejection fraction,
  • BNP, six minute walk test, and remodeling by contrast enhance echocardiogram

Estimated Enrollment: 18
Study Start Date: April 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  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: NCT00361855

Locations
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Neuronyx
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00361855     History of Changes
Other Study ID Numbers: CLP-05-018
Study First Received: August 7, 2006
Last Updated: September 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuronyx:
MI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014