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Trial record 2 of 2 for:    cardiomyocytes | Heart Failure | China

Treating Heart Failure With hPSC-CMs (HEAL-CHF)

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ClinicalTrials.gov Identifier: NCT03763136
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital with Nanjing Medical University
Information provided by (Responsible Party):
Help Therapeutics

Brief Summary:
Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in a human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of regenerated cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic ischemic cardiomyopathy.

Condition or disease Intervention/treatment Phase
Heart Failure Biological: hPSC-CM therapy Not Applicable

Detailed Description:
Patients with heart failure will be treated with allogenic human induced pluripotent stem cell-derived cardiomyocytes ( hPSC-CM ) from healthy donors. The cells will be injected directly into the myocardium at time of coronary artery bypass grafting. Patients will be assessed at 3, 6 and 12 months after cell transplantation for safety, feasibility and efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Human Epicardial Injection With Allogenic Induced Pluripotent Stem Cell-derived Cardiomyocytes in Ischemic Heart Failure
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: hPSC-CM therapy
Procedure: Injection of allogenic human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) at time of coronary artery bypass grafting surgery, 100 million hiPSC-CMs in 2.5-5mL medium suspension will be injected into the myocardium.
Biological: hPSC-CM therapy
Injection of allogenic human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) at time of coronary artery bypass grafting surgery, 100 million hiPSC-CMs in 2.5-5mL medium suspension will be injected into the myocardium.




Primary Outcome Measures :
  1. The number of patients with serious adverse events associated with cell therapy after cardiomyocyte injection. [ Time Frame: 12 months ]
    The primary safety endpoint of the study was the number of patients with serious adverse events associated with cell therapy after cardiomyocyte injection , primarily with persistent ventricular tachycardia, or accompanied by hemodynamic instability, or sudden cardiac death and examination of new tumors.


Secondary Outcome Measures :
  1. Assessment of infarction size [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by nuclear magnetic delay enhancement technique

  2. Change in local left ventricular function ( cardiomyocyte injection area ) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by nuclear magnetic delay enhancement technique

  3. Change in local left ventricular function ( cardiomyocyte injection area ) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by echocardiography

  4. Change in local left ventricular thickness [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by nuclear magnetic delay enhancement technique

  5. Change in local left ventricular thickness [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by echocardiography

  6. Change in local left ventricular thickness ( at the end of diastole) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by echocardiography

  7. Change in left ventricle ejection fraction (LVEF) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by nuclear magnetic delay enhancement technique

  8. Change in left ventricle ejection fraction (LVEF) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by echocardiography

  9. Change in left ventricle end diastolic volume ( LVEDV ) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by nuclear magnetic delay enhancement technique

  10. Change in left ventricle end diastolic volume ( LVEDV ) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by echocardiography

  11. Change in left ventricle end-systolic volume ( LVESV ) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by nuclear magnetic delay enhancement technique

  12. Change in left ventricle end-systolic volume ( LVESV ) [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by echocardiography

  13. Assessment of myocardial segmental perfusion [ Time Frame: at baseline, 3 months, 6 months, and 12 months ]
    measured by cMRI

  14. Cardiopulmonary function test: peak VO2 and PVO2 [ Time Frame: at baseline, 3 months, 6months ]

    Accurately measuring VO2 max involves a physical effort sufficient in duration and intensity to fully tax the aerobic energy system. In general clinical and athletic testing, this usually involves a graded exercise test (either on a treadmill or on a cycle ergometer) in which exercise intensity is progressively increased while measuring:

    ventilation and oxygen and carbon dioxide concentration of the inhaled and exhaled air. VO2 max is reached when oxygen consumption remains at a steady state despite an increase in workload.


  15. Efficacy clinical function assessed by change in 6 min walking test [ Time Frame: at baseline, 6 months ]
    A performance-based function that measures an individual's exercise capacity during a total of six minutes while walking on a hard, flat surface.

  16. New York Heart Association ( NYHA ) classification [ Time Frame: at baseline, 3,6,9,12 months ]
    the cardiac function was assessed into 4 classes (I-IV)

  17. Minnesota Living with Heart Failure Questionnaire ( MHLFQ ) score [ Time Frame: at baseline, 3,6,9,12 months ]
    the minimum score is 0, and maximum score is 105. And if the score change >=10 scores improvement , change >=10 scores deteriorate, no meaningful change

  18. Incidence of the major adverse cardiac events ( MACE ) endpoint, defined as the composite incidence of (1) Death, (2) Hospitalization for heart failure, or (3) Non-fatal Recurrent myocardial infarction [ Time Frame: 12 months ]
  19. Incidence of treatment-emergent adverse events [ Time Frame: 12 months ]
  20. the incidence of arrhythmia [ Time Frame: 48 hours after the procedure ]
    48 hours holter will be used to monitoring the heart beat 48h Holter

  21. Concentration of hs-cTnT, cTnI and CKMB [ Time Frame: every 12 hours for the first 48 hours after CABG surgery ]
    these parameters are serial myocardial injury marker.

  22. N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) level [ Time Frame: 12 months ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 35-75 years
  2. Signed informed consent
  3. Severe left ventricular systolic dysfunction with myocardial infarction history
  4. New York Heart Association (NYHA) Class III or IV despite optimal standard of care
  5. Indication for a conventional cardiac surgical procedure: coronary artery bypass grafting ( CABG ) (1) Class I a. Left ventricular dysfunction with obvious left main coronary artery lesion (level of evidence: B) b. Left ventricular dysfunction with a similar left main coronary artery lesion such as more significant (>70% diameter) coronary artery stenoses proximal to the left anterior descending or left circumflex artery (level of evidence: B) c. Left ventricular dysfunction with two or three lesions of the proximal left anterior descending (level of evidence: B) (2)Class IIa Left ventricular dysfunction with a large number of surviving, non-contracting or revascularizable cardiomyocytes, excluding the above-mentioned coronary anatomy (level of evidence: B)
  6. 30%<Ejection Fraction (LVEF)<45% as assessed by echocardiography ( measure in the first 6 months of recruit is included, excluding the measured values within 1 month of myocardial infarction )
  7. Echocardiography indicates a segmental wall motion reduction or no motion

Exclusion Criteria:

  1. Patients who have received treatments such as pacemakers or ICD or CRT device
  2. Patients with severe valvular disease or presence of a mechanical valve replacement
  3. Patients with persistent ventricular tachycardia or sudden cardiac death history
  4. Baseline glomerular filtration rate < 30 ml / min / 1.73m2
  5. Have a hematologic abnormality as evidenced by hematocrit < 25%
  6. Known, serious radiographic contrast allergy
  7. Have a coagulopathy condition
  8. Known allergies to penicillin or streptomycin
  9. Contra-indication to performance of a magnetic resonance imaging scan
  10. Organ transplant recipient
  11. History with malignant disease
  12. Non-cardiac condition that limits lifespan to < 1 year
  13. On chronic therapy with immunosuppressant medication such as glucocorticoid or TNFα antagonist
  14. Contra-indication to take immunosuppressant medication
  15. Serum positive for HIV, hepatitis BsAg, or non-viremic hepatitis C
  16. Participation in another intervention trial
  17. Female patient who is pregnant or nursing

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): NCT03763136


Contacts
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Contact: Jiaxian Wang, MD, PhD +86-18565616060 wangjx@helpsci.com.cn

Locations
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China, Jiangsu
HelpThera Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jiaxian Wang, Phd    +86-18565616060    wangjx@helpsci.com.cn   
Sponsors and Collaborators
Help Therapeutics
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Dongjin Wang, MD The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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Responsible Party: Help Therapeutics
ClinicalTrials.gov Identifier: NCT03763136     History of Changes
Other Study ID Numbers: JWang
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases