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Sponsored by: |
Neuronyx |
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Information provided by: | Neuronyx |
ClinicalTrials.gov Identifier: | NCT00361855 |
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 |
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Myocardial Infarction |
Drug: NX-CP105 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | April 2006 |
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | CLP-05-018 |
Study First Received: | August 7, 2006 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00361855 |
Health Authority: | United States: Food and Drug Administration |
MI |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |