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Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy (UCMSC-Heart)

Primary Purpose

Chronic Ischemic Heart Disease, Heart Failure, Angina

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UCMSC group
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ischemic Heart Disease focused on measuring cellular therapy, Chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, ischemic heart disease, allogeneic stem cell transplantation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 80 y
  • No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
  • Maximal tolerable angina and heart failure medication
  • NYHA functional classification (I-III)
  • Signed informed consent

Exclusion Criteria:

  • Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
  • Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
  • History with malignant disease within 5 y of inclusion or suspected malignity
  • Severe heart failure (NYHA functional classification IV)
  • Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
  • Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
  • Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
  • Patients with reduced immune response or treated with immunosuppressive medication
  • Combined with severe infectious diseases
  • Pregnant or fertile women
  • Socially and mentally disabilities

Sites / Locations

  • Department of cardiology,Affiliated Hospital to Academy of Military Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

UCMSC group

Control group

Arm Description

Patients in this arm received umbilical cord MSCs by intracoronary injection

Patients in this arm did not receive any intervention.

Outcomes

Primary Outcome Measures

Number and nature of adverse events
Evidence for new clinical/biological abnormalities.
Incidence of major adverse coronary events (MACE)
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.

Secondary Outcome Measures

Exercise Time and Level
Exercise time and level as assessed via six minute walk test.
Quantify myocardium perfusion measured by SPECT
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT.
Assessment of heart function by left ventricular ejection fraction
Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.
Clinical Improvement in NYHA Classification
The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure".

Full Information

First Posted
May 5, 2015
Last Updated
March 14, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02439541
Brief Title
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy
Acronym
UCMSC-Heart
Official Title
Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.
Detailed Description
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study. Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention. Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months. Clinical results will be analyzed after completion of 12 months of followup.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ischemic Heart Disease, Heart Failure, Angina
Keywords
cellular therapy, Chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, ischemic heart disease, allogeneic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCMSC group
Arm Type
Experimental
Arm Description
Patients in this arm received umbilical cord MSCs by intracoronary injection
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in this arm did not receive any intervention.
Intervention Type
Biological
Intervention Name(s)
UCMSC group
Intervention Description
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)
Primary Outcome Measure Information:
Title
Number and nature of adverse events
Description
Evidence for new clinical/biological abnormalities.
Time Frame
Within the first year after intracoronary infusion
Title
Incidence of major adverse coronary events (MACE)
Description
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
Time Frame
Within the first year after intracoronary infusion
Secondary Outcome Measure Information:
Title
Exercise Time and Level
Description
Exercise time and level as assessed via six minute walk test.
Time Frame
Post cell transplantation: 1, 3, 6, 12 months
Title
Quantify myocardium perfusion measured by SPECT
Description
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT.
Time Frame
Post cell transplantation: 6, 12 months
Title
Assessment of heart function by left ventricular ejection fraction
Description
Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.
Time Frame
Post cell transplantation: 1, 3, 6，12 months
Title
Clinical Improvement in NYHA Classification
Description
The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure".
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 y No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist). Maximal tolerable angina and heart failure medication NYHA functional classification (I-III) Signed informed consent Exclusion Criteria: Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI. Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month. History with malignant disease within 5 y of inclusion or suspected malignity Severe heart failure (NYHA functional classification IV) Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment Patients with reduced immune response or treated with immunosuppressive medication Combined with severe infectious diseases Pregnant or fertile women Socially and mentally disabilities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Zhang, M.D
Phone
+86-010-66947136
Email
zxz947136@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Liu, M.D
Organizational Affiliation
307-IVY Translational Medicine Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaozhong Zhang, M.D
Organizational Affiliation
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Zhang, M.D
Phone
+86-010-66947136
Email
zxz947136@126.com

12. IPD Sharing Statement

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Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy

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