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Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

This study is not yet open for participant recruitment.
Verified January 2016 by South China Research Center for Stem Cell and Regenerative Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02666391
First Posted: January 28, 2016
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
South China Research Center for Stem Cell and Regenerative Medicine
  Purpose
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.

Condition Intervention Phase
Acute Myocardial Infarction Myocardial Infarction Ischemic Cardiomyopathy Biological: umbilical cord mesenchymal stem cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by South China Research Center for Stem Cell and Regenerative Medicine:

Primary Outcome Measures:
  • Change in global left ventricular ejection fraction (LVEF)measured by echocardiography. [ Time Frame: 1 week, 6 month, 12 month,18 month ]
  • Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT). [ Time Frame: 1 week, 18 month ]

Secondary Outcome Measures:
  • Pump failure Killip classification [ Time Frame: baseline, 1 week, 1 month, 6 month, 12 month,18 month ]
  • New York Heart Association(NYHA) classification [ Time Frame: 1 week, 1 month, 6 month, 12 month,18 month ]
  • Occurrence of major adverse event [ Time Frame: 3 day, 1 week, 1 month, 6 month, 12 month,18 month ]

Estimated Enrollment: 64
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UCMSCs
Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs)
Biological: umbilical cord mesenchymal stem cells
No Intervention: controls
Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery;
  • LVEF (left ventricular ejection fraction): 25-45%;
  • Age between 18 and 70, borh gender;
  • Women of childbearing age agreed to take contraceptive measures during the whole study period;
  • No psychiatric illnesses and speaking dysfunction;
  • Informed consent.

Exclusion Criteria:

  • Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF<24%;
  • Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value;
  • Patients suffered from severe arrhythmia;
  • Patients suffered from stent thrombosis;
  • Patients receiving immunosuppressive therapy;
  • Patients have tumor or other lethal diseases (expectation of life<6 months);
  • Women who plan to be pregnant or are pregnant or nursing;
  • Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen);
  • Other clinical trial participants within 3 months;
  • Investigators judge other conditions not suitable for inclusion.
  Contacts and Locations
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): NCT02666391


Contacts
Contact: Xuetao Pei, M.D., Ph.D 8610-68164807 AMMS0906@163.com
Contact: Junnian Zhou, Ph.D 8620-89199011 zhoujunnian@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine
Sun Yat-sen University
  More Information

Publications:
Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02666391     History of Changes
Obsolete Identifiers: NCT02568956
Other Study ID Numbers: UCMSC-2
First Submitted: January 21, 2016
First Posted: January 28, 2016
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Ischemia
Infarction
Myocardial Infarction
Cardiomyopathies
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases