Clinical Drug Experience Knowledgebase

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

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.