Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure

NCT05566600 | Unknown Early Phase 1 DMC

• 1 other identifier: JFYang
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.

Conditions

Ischemic Heart Failure; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Safety in terms of the incidence and severity of adverse events

  Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for \>15 seconds and newly formed tumor

  within 1 month post CABG surgery

Secondary Outcomes (9)

• Incidence of adverse events

  1~6 months post CABG surgery

• Cardiac assessment

  1~6 months post CABG surgery

• Incidence of newly formed tumor

  1~12 months post CABG surgery

• Immunogenic assessments

  1 month, 3 months and 6 months post CABG surgery

• Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI

  from baseline to 12 months at 3, 6, and 12 months post CABG surgery

Study Arms (4)

Dose level 1

EXPERIMENTAL

100 million iPSC-CMs administration

Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Dose level 2

EXPERIMENTAL

200 million iPSC-CMs administration

Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Dose level 3

EXPERIMENTAL

400 million iPSC-CMs administration

Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Control

NO INTERVENTION

Participants will received CABG surgery only

Interventions

Human (allogeneic) iPS-cell-derived cardiomyocyte BIOLOGICAL

10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium

Dose level 1; Dose level 2; Dose level 3

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 35-75 (including 35 and 75).
• Signed the Informed Consent Form (ICF).
• Have chronic left ventricular dysfunction.
• Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
• Have indications for Coronary Artery Bypass Grafting.
• Weakening or absence of segmental regional wall motion as determined by standard imaging

You may not qualify if:

• PRA ≥ 20% or DSA-positive
• Patient received ICD transplantation, CRT or similar treatment.
• Patients with valvular heart disease or received heart valvular disease
• Patients received treatment of percutaneous transluminal coronary intervention (PCI)
• Patients with atrial fibrillation
• Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
• Baseline glomerular filtration rate \<30ml/min/1.73m2.
• Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
• Hematological abnormality: A hematocrit \<25% as determined by HCT, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation.
• Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
• Coagulopathy (INR\>1.3) not due to a reversible cause.
• Contra-indication to performance of a MRI scan.
• Recipients of organ transplant.
• Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
• Non-cardiac condition that limits lifespan \<1 year.

Sponsors & Collaborators

• Help Therapeutics: lead
• Central South University: collaborator

Study Sites (2)

The second xiangya hospital of central south university

Changsha, Hunan, 410000, China

RECRUITING

HelpThera

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Central Study Contacts

Jiaxian Wang

CONTACT

+86-18565616060; wangjx@helpsci.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 4, 2022
• Study Start: October 9, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (2)