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

• Sponsor: Chinese Academy of Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02635464
• Collaborator: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Enrollment: 50
• Location: 1
• Arms: 3
• Duration (Months): 46
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Ischemic Cardiomyopathy	Biological: hUC-MSCs+Injectable collagen scaffold+CABG; Biological: hUC-MSCs+CABG; Procedure: CABG	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Myocardial blood flow [1, 3, 6, 12 and 24 months]

   Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).

2. 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).

3. Infarct size [1, 3, 6, 12 and 24 months]

   Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).

4. New York Heart Association (NYHA) Functional Classification [1, 3, 6, 12 and 24 months]

   Change in clinical symptoms evaluated by NYHA.

5. Canadian Cardiovascular Society (CCS) Angina Grading Scale [1, 3, 6, 12 and 24 months]

   Change in clinical symptoms evaluated by CCS.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jianwu Dai, Ph.D., Chinese Academy of Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
• ClinicalTrials.gov Identifier: NCT02635464
• Other Study ID Numbers: CAS-XDA-CIC/IGDB
• First Posted: Dec 18, 2015
• Last Update Posted: Dec 23, 2020
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Cardiomyopathies; Ischemia

Study Results

No Results Posted as of Dec 23, 2020