Safety Study of Bone Marrow Derived Cells to Treat Damaged Heart Muscle
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Each patient will go through three phases during the study. The first is the
      screening/baseline phase, the second is the treatment phase, and the third is the follow-up
      phase.

        -  The procedures that are required during the SCREENING/BASELINE PERIOD can be done in a
           doctor's office outside of the hospital.

             -  Patients will be asked about their past medical conditions and the medicines you
                are taking.

             -  Patients will be asked how often you get chest pain.

             -  Patients will have a complete physical examination.

             -  Patient vital signs (temperature, blood pressure, pulse and breathing rate) and
                weight will be measured.

             -  Patients will give blood (about 2 tablespoons) and urine for routine laboratory
                tests, to see if you have been infected with certain viruses (HIV, Hepatitis B,
                Hepatitis C, CMV) and to test to determine blood type. A pregnancy test will be
                done if patients are capable of getting pregnant.

             -  Patients will have an electrocardiogram (ECG - a painless heart beat tracing).

             -  Patients will be asked to walk as fast as they can for six minutes.

             -  Patients will have an x-ray type of test called a nuclear scan (SPECT) of your
                heart. A very small amount of a radioactive material will be injected into a vein
                during this test, which allows the doctor to evaluate blood flow in the heart.

             -  Patients will have an echocardiogram, a procedure that uses sound waves to look at
                the position, size, and movement of heart valves and heart wall, as well as the
                direction of blood flow within the heart chambers. A solution that improves the
                ability of the echocardiogram device to look at the heart will be injected into a
                vein as part of this procedure.

             -  Patients will be asked to wear a Holter monitor (a very small ECG machine) for 24
                hours that will be worn around the neck in a Velcro pouch or in the shirt pocket.
                The monitor will be attached to the chest by three small adhesive patches and will
                be used to collect heart beat information. Patients will take off the patches after
                24 hours and return the monitor to the study doctor.

        -  During the TREATMENT PERIOD patients will be kept in the hospital for at least 3 days
           during which they will receive the new investigational drug (NX-CP105).

             -  Patients will need to be admitted to the hospital about a day before thet receive
                the study drug (bone marrow cells). During this time patients will have a procedure
                called cardiac catheterization. The study doctor will make a small puncture in the
                groin after the area is numbed with a local anesthetic (similar to Novocaine use by
                a dentist). Two thin catheters (tubes) will be placed in the groin area, one in a
                vein and one in an artery (large blood vessels). Blood thinners will be given
                during this procedure to help prevent blood clots. A series of thinner tubes
                (catheters) will then be inserted into the first tubes and will be carefully pushed
                up into the heart chambers. These catheters will be used to produce a 3-dimensional
                colored map (NOGA) that shows where the heart has been damaged. When mapping is
                complete, this catheter will be taken out and a new device with a needle in the tip
                will be run through the tubes. Using the map of your heart, the doctor will inject
                NX CP105 into parts of the heart that look like they were damaged.

             -  After NX-CP105 is injected, all the tubes will be removed. After these procedures,
                patients will have another echocardiogram to look for heart or other problems that
                may have happened during the procedure. Patients will then be admitted to the
                intensive care unit (ICU) for at least 24 hours. Patients will remain in the
                hospital for at least 72 hours (3 days) after receiving NX-CP105.

             -  Before leaving the hospital, patients will have another physical examination,
                including vital sign measurements and ECGs. Blood and urine laboratory safety
                samples will be collected

        -  The FOLLOW-UP PERIOD lasts 12 months. Patients will be asked to return to the study
           doctor for regular visits on Day 7, Day 14, Day 21, and 2 months, 3 months, 6 months and
           12 months after receiving NX CP105. At each study visit, patients will be asked to do
           the following things:

             -  Answer questions about any symptoms that you have had since the last study visit,
                including any chest pain.

             -  Have a physical examination.

             -  Have vital signs will be measured.

             -  Give blood for routine laboratory tests.

             -  Have an ECG.

             -  Wear a Holter Monitor for 24 hours (except at the 6 and 12 month visits).

             -  Have a six minute walk test (at the 3 and 6 month visits only).

             -  Have a nuclear scan (SPECT) of the heart (at the 3 and 6 month visits only).

             -  Have an echocardiogram (at the 3 and 6 month visits only).

             -  Patients will also be admitted to the hospital to have another cardiac
                catheterization and NOGA mapping procedure when you come back for the 3 month
                follow-up visit.
    

Intervention name(s): NX-CP105
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MI