Intravenous MSC Therapy on Ischemia-Reperfusion Injury in Patients With Myocardial Infarction

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The investigators scheduled to assess the value of intravenous injection of WJ-MSC in patients with ST-segment elevation myocardial infarction (STEMI).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Criteria

Inclusion Criteria:

1. Age between 18 and 75;

2. First performance of anterior acute ST-segment elevation myocardial infarction (STEMI), Killip grade 2 or below on admission;

3. Completing emergency percutaneous coronary intervention within 12h, with TIMI flow grade 0 or 1 (before stent implantation) and 3 (after stent implantation);

4. LVEF in echocardiography is 45% or below primary PCI.

Exclusion Criteria:

1. Medical history of Q wave myocardial infarction, significant valve disease, pericarditis, pericardial tamponade, myocardiopathy, chronic heart failure or cardio embolism;

2. Non ST-segment elevation myocardial infarction;

3. Chronic occlusion in LCX or RCA besides LAD;

4. Diagnosed with severe coronary artery disease but not yet causing a loss of heart function;

5. Hemodynamic disorders, shock or respiratory failure on admission;

6. Atrial fibrillation with warfarin treatment only or at high risk of bleeding;

7. Constant tachycardia, malignant arrhythmia, complete atrioventricular block, new-onset complete left bundle branch block (LBBB) or pacemaker implantation;

8. Mechanical complications of acute myocardial infarction (interventricular septal defect, rupture of papillary muscle, etc.) or huge left ventricular aneurysm could only be corrected through surgical procedures;

9. Chronic pulmonary heart disease (COPD, bronchial asthma, chronic bronchitis, emphysema or pulmonary heart disease), autoimmune disease or patients on immunosuppressive therapy;

10. Acute infective disease;

11. Hepatitis B/C virus or HIV;

12. Blood system diseases (thrombocytopenia, severe anemia, leukemia, etc.);

13. Severe renal insufficiency, with creatinine clearance (CCr) <33 ml/min or serum creatinine >133 μmol/L;

14. Obvious abnormalities in liver function (ALT and AST 3 times higher than the upper limit of normal value);

15. Medical history of cerebral hemorrhage;

16. Medical history of the malignant tumor;

17. Cognitive impairment, dementia or severe mental illness (SMI);

18. Substantial disability negatively influenced regular follow-up research;

19. Systematic diseases not been effectively controlled or life expectancy < 1 year;

20. Pregnant or lactating women;

21. Not suitable for MRI examination, or could not stick to treatment plans;

22. Could not or not willing to give written informed consent.

Exit Criteria:

1. Intolerable infaust events or changed treatment strategy leading to serious violations of trial conduct;

2. Requiring to exit the clinical trial;

3. Research scheme violations, severely disrupted safety and effectiveness of the trail;

4. Lost to follow-up cases;

5. Conceiving children or want to do that during the treatment period;

6. Candidates not fit to carry on the trial.