Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

Chinese Academy of Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Ischemic Cardiomyopathy

Treatments: Biological: hUC-MSCs+CABG; Procedure: CABG; Biological: hUC-MSCs+Injectable collagen scaffold+CABG

Study type: Interventional

Funder types: Other

Identifiers

NCT02635464

CAS-XDA-CIC/IGDB

Details and patient eligibility

About

The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.

Enrollment: 50 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 35-65 years old.
2. Chronic coronary artery disease with coronary Stenosis detectable by percutaneous coronary intervention (PCI). Ineligibility for percutaneous revascularization, as assessed by coronary arteriography. Ineligibility for percutaneous revascularization procedures was determined by 2 expert committees: a surgical committee comprising 2 cardiovascular surgeons and a noninvasive cardiologist, and an interventional committee comprising 2 interventional cardiologists and 1 noninvasive cardiologist.
3. MRI confirmed that chronic coronary artery disease and ischemic regions.
4. Left ventricular ejection fraction (LVEF)≤40%.
5. NYHA Class II-IV.
6. No organ dysfunction for lung, liver and kidney.
7. Patients are able and willing to observe therapeutic effect and adverse events.
8. Signed informed consent.
9. Negative serum pregnancy test.
10. No coagulation dysfunction.
11. Glycated hemoglobin ≤6.5.

Exclusion criteria

1. Lactating or pregnant woman.
2. Ineligibility for CABG.
3. Unexplainable baseline laboratory abnormalities.
4. Sensitivity to any of the study medications.
5. Acute myocardial infarction within 1 months of enrollment in the study.
6. Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation.
7. History of life threatening allergic or immune-mediated reaction.
8. Systemic infection or severe local infection.
9. Shock or MODS or patients cannot cooperate with doctors.
10. Severe heart, lung, liver or renal dysfunction.
11. Taking medicine that might have effect on outcomes assess.
12. Suffering HIV, Hepatitis B or Hepatitis C.
13. Participation in any clinical trial in recent three months.
14. History of mental illness or suicide risk.
15. High expectation or unrealistic demands.
16. Recently suffered a lot of radiation exposure.
17. Previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival.
18. Patients with serious complications of coronary artery disease (e.g., perforation of interventricular septum and ventricular aneurysm and mitral regurgitation due to papillary muscle dysfunction).
19. Abnormal coagulation function.
20. Patients with hemodynamic instability which may lead to serious complications.
21. Any condition that, in the judgment of the investigator, would place the patient at under risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups

hUC-MSCs+Injectable collagen scaffold+CABG

Experimental group

Treatment:

Biological: hUC-MSCs+Injectable collagen scaffold+CABG

hUC-MSCs+CABG

Active Comparator group

Treatment:

Biological: hUC-MSCs+CABG

CABG

Active Comparator group

Treatment:

Procedure: CABG