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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02635464
• Date of registration: 13/12/2015
• Prospective Registration: No
• Primary sponsor: Chinese Academy of Sciences
• Public title: Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
• Scientific title: The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
• Date of first enrolment: October 2015
• Target sample size: 45
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02635464
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Jianwu Dai, Ph.D.
• Affiliation: Chinese Academy of Sciences

Key inclusion & exclusion criteria

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.



Age minimum: 35 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Ischemic Cardiomyopathy

Intervention(s)

Biological: hUC-MSCs+Injectable collagen scaffold+CABG

Biological: hUC-MSCs+CABG

Procedure: CABG

Primary Outcome(s)

Incidence of treatment-emergent adverse events [Time Frame: up to 24 months after surgery]

Secondary Outcome(s)

Canadian Cardiovascular Society (CCS) Angina Grading Scale [Time Frame: 1, 3, 6, 12 and 24 months]

New York Heart Association (NYHA) Functional Classification [Time Frame: 1, 3, 6, 12 and 24 months]

Left ventricle ejection fraction (LVEF) [Time Frame: 1, 3, 6, 12 and 24 months]

Myocardial blood flow [Time Frame: 1, 3, 6, 12 and 24 months]

Infarct size [Time Frame: 1, 3, 6, 12 and 24 months]

Secondary ID(s)

CAS-XDA-CIC/IGDB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School