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

NCT00361855 | Completed Phase 1

• 1 other identifier: CLP-05-018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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-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.

Conditions

Myocardial Infarction

Keywords

MI

Outcome Measures

Primary Outcomes (2)

• Safety as measured by clinical laboratory values, vital signs,

• ECG/holter monitoring, echocardiogram

Secondary Outcomes (2)

• 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

Interventions

NX-CP105 DRUG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age (inclusive)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuronyx: lead

Study Sites (5)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 9, 2006
• Study Start: April 1, 2006
• Last Updated: September 10, 2008

Record last verified: 2008-09

Locations

US (5)