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

Phase 1

Completed

• Conditions: Chronic Ischemic Cardiomyopathy
• Interventions: Biological: hUC-MSCs+Injectable collagen scaffold+CABG; Biological: hUC-MSCs+CABG; Procedure: CABG

• Registration Number: NCT02635464
• Lead Sponsor: Chinese Academy of Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Status Verified: 2015-12
• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-18
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hUC-MSCs+Injectable collagen scaffold+CABG	hUC-MSCs+Injectable collagen scaffold+CABG	-
hUC-MSCs+CABG	hUC-MSCs+CABG	-
CABG	CABG	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	up to 24 months after surgery	Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured.

Secondary Outcome Measures

Name	Time	Method
Left ventricle ejection fraction (LVEF)	1, 3, 6, 12 and 24 months	Change in LVEF as measured by ultrasonic cardiogram (UCG) and Cardiac magnetic resonance imaging (MRI).
Infarct size	1, 3, 6, 12 and 24 months	Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).
Myocardial blood flow	1, 3, 6, 12 and 24 months	Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).
New York Heart Association (NYHA) Functional Classification	1, 3, 6, 12 and 24 months	Change in clinical symptoms evaluated by NYHA.
Canadian Cardiovascular Society (CCS) Angina Grading Scale	1, 3, 6, 12 and 24 months	Change in clinical symptoms evaluated by CCS.

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China