Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361855
Status:
COMPLETED
Last Update Posted:
2008-09-10
First Post:
2006-08-07
Brief Title:
Safety Study of Bone Marrow Derived Cells to Treat Damaged Heart Muscle
Sponsor:
Neuronyx
Organization:
Neuronyx
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 screeningbaseline phase the second is the treatment phase and the third is the follow-up phase
The procedures that are required during the SCREENINGBASELINE PERIOD can be done in a doctors 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
The procedures that are required during the SCREENINGBASELINE PERIOD can be done in a doctors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None