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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuronyx

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