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

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ClinicalTrials.gov Identifier: NCT02439541
Recruitment Status : Unknown
Verified March 2016 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 8, 2015
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Ivy Institute of Stem Cells Co. Ltd
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Chronic Ischemic Heart Disease Heart Failure Angina Biological: UCMSC group Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: UCMSC group
Patients in this arm received umbilical cord MSCs by intracoronary injection
Biological: UCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)

No Intervention: Control group
Patients in this arm did not receive any intervention.



Primary Outcome Measures :
  1. Number and nature of adverse events [ Time Frame: Within the first year after intracoronary infusion ]
    Evidence for new clinical/biological abnormalities.

  2. Incidence of major adverse coronary events (MACE) [ Time Frame: Within the first year after intracoronary infusion ]
    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 :
  1. Exercise Time and Level [ Time Frame: Post cell transplantation: 1, 3, 6, 12 months ]
    Exercise time and level as assessed via six minute walk test.

  2. Quantify myocardium perfusion measured by SPECT [ Time Frame: Post cell transplantation: 6, 12 months ]
    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.

  3. Assessment of heart function by left ventricular ejection fraction [ Time Frame: Post cell transplantation: 1, 3, 6,12 months ]
    Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.

  4. Clinical Improvement in NYHA Classification [ Time Frame: 1 year ]
    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".



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439541


Contacts
Contact: Xiaozhong Zhang, M.D +86-010-66947136 zxz947136@126.com

Locations
China
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, China, 100071
Contact: Xiaozhong Zhang, M.D    +86-010-66947136    zxz947136@126.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Ivy Institute of Stem Cells Co. Ltd
Investigators
Study Chair: Bing Liu, M.D 307-IVY Translational Medicine Center
Principal Investigator: Xiaozhong Zhang, M.D Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences

Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02439541     History of Changes
Other Study ID Numbers: 307-IVY-SC-001
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
cellular therapy
Chronic ischemic heart disease
phase 1/2 clinical study
human umbilical cord mesenchymal stem cell
ischemic heart disease
allogeneic stem cell transplantation

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases