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study inclusion criteria


The following are criteria for the inclusion and exclusion of patients to the Phase I stem cell clinical trial underway at Johns Hopkins and titled: 2A Phase I randomized, double-blind, placebo-controlled, dose-escalation study to determine the safety of intravenous, ex-vivo cultured, human mesenchymal stem cells (Provacel) following acute myocardial infarction. 

The study involves men and women who are clinically stable following MI.

INCLUSION CRITERIA:

1. Subject is a male or female between the age of 21 and 85.

2. Subject has experienced a first myocardial infarction one to 10 days prior to randomization.

3. Subject has a patent infarct-related artery demonstrated by coronary arteriogram performed for clinical reasons.

4. Subject has a global left ventricular systolic dysfunction with an ejection fraction of <50% and >/30% as determined by clinical assessment of left ventricular function (echocardiography or left ventriculography).

5. Subject has an elevation of >2 times upper limit of normal of CK-MB or troponin during initial hospitalization for the index MI.

6. Subject has been hemodynamically stable for at least 24 hours prior to randomization. Hemodynamic stability is defined as a 24-hour period without: 1) a need for parenteral inotropic support, 2) systolic blood pressure of <80 mmHg for more than one hour, or 3) resting heart rate of >100 beats per minute for more than one hour.

7. Subject has adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) > 50% of predicted and peripheral artery oxygen saturation (SaO2) > 97% on a maximum of 2L/minute supplemental O2 via nasal cannula.

8. Subject has a Karnofsky performance status score of >/60 (Maximal  needs includes: requires occasional assistance but is able to care for most of own needs).

9. Subject provides written informed consent.

10. Subject provides written authorization for use and disclosure of protected health information (PHI).

11. Subject (either male or female) agrees not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and to use of contraception as specified in the protocol.

12. Subject agrees to enroll into protocol-driven long-term follow up for 2 years after randomization.

EXCLUSION CRITERIA:

1. Subject underwent revascularization via a surgical coronary artery bypass procedure.

2. Subject has an indication for further revascularization procedures anticipated during the 6-month study period, including, but not limited to, coronary artery bypass grafting and percutaneous coronary intervention procedures.

3. Subject has decompensated heart failure (NYHA Class IV).

4. Subject is currently using mechanical ventilation or has required mechanical ventilation at any time after the index event.

5. Subject has a prior clinical history of myocardial infarction, cardiomyopathy, previous admissions for congestive heart failure, or depressed left ventricular function before the index event.

6. Subject has clinically significant primary valvular heart disease.

7. Subject has or requires an implantable electronic defibrillator, pacemaker, or has other contraindication to MRI scanning.

8. Subject has a QTc interval of (3)550 ms on baseline 12-lead ECG, as determined by the Investigator.

9. Subject has evidence of a life-threatening arrhythmia on baseline ECG monitoring as determined by the Investigator. Life-threatening arrhythmias include non-sustained ventricular tachycardia (>20 consecutive beats of ventricular tachycardia),  complete heart block, or pauses of >2 seconds.

GENERAL MEDICAL EXCLUSION CRITERIA:

1. Subject has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the subject (e.g., end-stage liver disease, pulmonary hypertension, etc.).

2. Subject is pregnant or lactating.

3. Subject has a serum creatinine (3) 2.0 mg/dL.

4. Subject is allergic to gadolinium contrast agent.

5. Subject has experienced a previous systemic allergic reaction to bovine or porcine products.

6. Subject has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.

7. Subject has received a previous autologous or allogeneic bone marrow transplant, peripheral stem cell transplant or solid organ transplantation.

8. Subject has received any investigational/compassionate use agent or device within 30 days prior to randomization (Visit 2), or anticipates receiving an investigational/compassionate use agent or device at any time during the study.

9. Subject has a history of alcohol or recreational drug abuse within 6 months prior to randomization (Visit 2).

10. Subject serum is positive for HIV-1 or HIV-2 antibody.

11. Subject serum is positive for Hepatitis B surface antigen.

12. Subject serum is positive for Hepatitis C antibody.

13. Subject has undergone any major surgical procedure or major trauma within 14 days prior to randomization.

14. Subject has a body weight >150 kg.

15. Subject has a chronic systemic autoimmune disease, including, but not limited to, systemic lupus erythematosis, rheumatoid arthritis, scleroderma, or sarcoidosis.

16. Subject has taken chronic doses of immunosuppressant medication within 14 days prior to randomization (Visit 2).

 

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