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

The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

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.

Study Overview

• Status: Completed
• Conditions: Chronic Ischemic Cardiomyopathy
• Intervention / Treatment: Biological: hUC-MSCs+Injectable collagen scaffold+CABG; Biological: hUC-MSCs+CABG; Procedure: CABG

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hUC-MSCs+Injectable collagen scaffold+CABG	Biological: hUC-MSCs+Injectable collagen scaffold+CABG; Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region.
Active Comparator: hUC-MSCs+CABG	Biological: hUC-MSCs+CABG; Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.
Active Comparator: CABG	Procedure: CABG; Patients underwent CABG alone.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General Publications

• He X, Wang Q, Zhao Y, Zhang H, Wang B, Pan J, Li J, Yu H, Wang L, Dai J, Wang D. Effect of Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells in Patients With Chronic Ischemic Heart Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016236. doi: 10.1001/jamanetworkopen.2020.16236.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Ischemia; Cardiomyopathies
• Other Study ID Numbers: CAS-XDA-CIC/IGDB