Treating Congestive HF With hiPSC-CMs Through Endocardial Injection
NCT ID: NCT04982081
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2021-09-21
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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hiPSC-CM therapy low dosage
hiPSC-CM therapy
20 patients with congestive heart failure who met the inclusion and exclusion criteria will be recruited. After being fully informed and signed the informed consent, the patients will be randomly divided into two dosage groups: 100 million cells (10 patients) and 400 million cells (10 patients). Human iPSC-derived cardiomyocytes will be injected into the myocardium through a transcatheter endocardial injection system.
hiPSC-CM therapy high dosage
hiPSC-CM therapy
20 patients with congestive heart failure who met the inclusion and exclusion criteria will be recruited. After being fully informed and signed the informed consent, the patients will be randomly divided into two dosage groups: 100 million cells (10 patients) and 400 million cells (10 patients). Human iPSC-derived cardiomyocytes will be injected into the myocardium through a transcatheter endocardial injection system.
Interventions
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hiPSC-CM therapy
20 patients with congestive heart failure who met the inclusion and exclusion criteria will be recruited. After being fully informed and signed the informed consent, the patients will be randomly divided into two dosage groups: 100 million cells (10 patients) and 400 million cells (10 patients). Human iPSC-derived cardiomyocytes will be injected into the myocardium through a transcatheter endocardial injection system.
Eligibility Criteria
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Inclusion Criteria
2. Signed the informed consent.
3. Patients with congestive heart failure who have received regular treatment for heart failure.
4. New York Heart Association (NYHA) Class III or IV despite optimal standard of care
5. Left Ventricular Ejection Fraction (LVEF)\<40% as assessed by echocardiography ( measure in the 3 months of recruit is included, excluding the measured values within 1 month of myocardial infarction ）
6. The thickness of left ventricular ≥8mm
7. Female patient who is not pregnant or nursing during the clinical trial
Exclusion Criteria
2. Patients received treatments such as pacemakers, ICD or CRT device.
3. Patient with severe valvular disease or presence of a mechanical valve replacement, such as PCI implantation, or patients requiring simultaneous radiofrequency ablation of atrial fibrillation.
4. Patient with any therapeutic traumatic heart surgery within 30 days.
5. Hemodynamic instability or cardiogenic shock.
6. Right heart failure.
7. Restrictive cardiomyopathy such as amyloidosis, sarcoidosis or hematochromia, constrictive pericarditis.
8. Myocardial infarction occurred within 30 days or stroke occurred within 60 days before enrollment.
9. Thickness at left ventricular free wall infarction \< 6 mm.
10. Severe ventricular arrhythmias (persistent ventricular tachycardia or other conditions that the investigator considers necessary to exclude).
11. Baseline glomerular filtration rate \< 30 ml/min / 1.73 m2.
12. Abnormal liver function: ALT or AST 3 times higher than the normal value.
13. Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cells count \<2,500/ul or platelet count \<100000 / ul.
14. Known allergies to penicillin, streptomycin or radiocontrast agent.
15. Abnormal coagulation function, INR \> 1.3, which cannot be corrected.
16. Contra-indication to performance of a magnetic resonance imaging scan and PET/ECT examinations.
17. Organ transplant recipient
18. Patients with other malignant disease within 5 years prior to enrollment.
19. Non-cardiac condition that limits lifespan to \< 1 year
20. On chronic therapy with immunosuppressant medication such as glucocorticoid or TNFα antagonist
21. Contra-indication to take immunosuppressant medication.
22. Serum positive for infectious diseases (HIV, HBV, HCV, TP).
23. Participated in other clinical trials within the previous 3 months .
24. Female patient who is pregnant or nursing.
25. Other condition that the investigator considers inappropriate for participation in the study.
18 Years
75 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Help Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Ling Tao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital
Locations
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Help Therapeutics
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LTao
Identifier Type: -
Identifier Source: org_study_id
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