Safety Study of Bone Marrow Derived Cells to Treat Damaged Heart Muscle
NCT00361855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2008-09-10
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
Interventions
- DRUG
-
NX-CP105
Sponsors & Collaborators
-
Neuronyx
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
Countries
- United States
Study Locations
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