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Two-Year Heart Failure Study with Allogeneic Myoblast Transplatation

Clinical Safety of Allogeneic Myoblasts Transplantation to Treat with Ventricle Aneurysm after Myocardial Infarction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039590
Enrollment
Unknown
Registered
2020-11-02
Start date
2016-02-01
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial infarction with ventricular aneurysm

Interventions

experimental group:Skeletal myoblast transplantation

Sponsors

The Third Affiliated Hospital of Xinxiang Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Severe congestive heart failure NYHA Class II/III; 2. Heart CT images show patients with old myocardial infarction and local ventricular wall dysfunction; 3. Ejection fraction <= 45%; 4. The patient must sign a written informed consent before the procedure; 5. There are indications for CABG surgery.

Exclusion criteria

Exclusion criteria: 1. Aged > 75 years old; 2. Recently (within 4 weeks), a history of acute coronary syndrome (eg, MI Q wave and/or non-Q wave), hospitalization due to unstable angina or cerebrovascular syndrome (onset); 3. There is a history of continuous ventricular tachycardia or fibrillation; 4. The patient has an implantable defibrillator (ICD); 5. Combined with other diseases such as valvular heart disease (aortic valve, mitral valve disease requires valve replacement, etc.); 6. Abnormal prothrombin or partial thromboplastin time or thrombocytopenia (platelet count 50mg/dL, creatinine 2.5mg/dL) or liver disease (eg, SGOT/AST or SGPT/ALT > 3 ULN); 8. History of drug exposure; 9. The following positive patients: human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV), syphilis (RPR), cytomegalovirus (CMV-IgM); 10. Have a history of skeletal muscle diseases, such as myopathy; 11. Female patients who are pregnant or breastfeeding or have reproductive capacity who are unwilling to control birth during treatment; 12. Concurrent infection; 13. According to the judgement of the investigator, any major diseases that will interfere with the therapeutic effect of myoblast cell transplantation in the implementation of the plan, safety to the patient.

Design outcomes

Primary

MeasureTime frame
Heart function;

Secondary

MeasureTime frame
Heart wall thickness;

Countries

China

Contacts

Public ContactLi Wenbin

The Third Affiliated Hospital of Xinxiang Medical College

1569800554@qq.com+86 13623902217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026