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

NCT02635464 | Completed Phase 1

• 1 other identifier: CAS-XDA-CIC/IGDB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Myocardial blood flow

  1, 3, 6, 12 and 24 months

• Left ventricle ejection fraction (LVEF)

  1, 3, 6, 12 and 24 months

• Infarct size

  1, 3, 6, 12 and 24 months

• New York Heart Association (NYHA) Functional Classification

  1, 3, 6, 12 and 24 months

• Canadian Cardiovascular Society (CCS) Angina Grading Scale

  1, 3, 6, 12 and 24 months

Study Arms (3)

hUC-MSCs+Injectable collagen scaffold+CABG

EXPERIMENTAL

Biological: hUC-MSCs+Injectable collagen scaffold+CABG

hUC-MSCs+CABG

ACTIVE COMPARATOR

Biological: hUC-MSCs+CABG

CABG

ACTIVE COMPARATOR

Procedure: CABG

Interventions

hUC-MSCs+Injectable collagen scaffold+CABG BIOLOGICAL

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.

hUC-MSCs+Injectable collagen scaffold+CABG

hUC-MSCs+CABG BIOLOGICAL

Patients underwent Coronary Artery Bypass Surgery (CABG) with 10\^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.

hUC-MSCs+CABG

CABG PROCEDURE

Patients underwent CABG alone.

CABG

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 35-65 years old.
• 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.
• MRI confirmed that chronic coronary artery disease and ischemic regions.
• Left ventricular ejection fraction (LVEF)≤40%.
• NYHA Class II-IV.
• No organ dysfunction for lung, liver and kidney.
• Patients are able and willing to observe therapeutic effect and adverse events.
• Signed informed consent.
• Negative serum pregnancy test.
• No coagulation dysfunction.
• Glycated hemoglobin ≤6.5.

You may not qualify if:

• Lactating or pregnant woman.
• Ineligibility for CABG.
• Unexplainable baseline laboratory abnormalities.
• Sensitivity to any of the study medications.
• Acute myocardial infarction within 1 months of enrollment in the study.
• Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation.
• History of life threatening allergic or immune-mediated reaction.
• Systemic infection or severe local infection.
• Shock or MODS or patients cannot cooperate with doctors.
• Severe heart, lung, liver or renal dysfunction.
• Taking medicine that might have effect on outcomes assess.
• Suffering HIV, Hepatitis B or Hepatitis C.
• Participation in any clinical trial in recent three months.
• History of mental illness or suicide risk.
• High expectation or unrealistic demands.

Sponsors & Collaborators

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

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• 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.

  PMID: 32910197 DERIVED

Study Officials

• Jianwu Dai, Ph.D.

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: December 13, 2015
• First Posted: December 18, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 23, 2020

Record last verified: 2015-12

Locations

CN (1)