Clinical Trial of Human (Allogeneic) iPS Cell-derived Cardiomyocytes Sheet for Ischemic Cardiomyopathy

NCT04696328 | Unknown Phase 1 DMC

• 1 other identifier: CVSC0005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Targeting patients with severe ischemic cardiomyopathy, the purpose of this study is as follows: to confirm short-term efficacy by observing changes and transitions in cardiac function and clinical symptoms compared with each patient's baseline (before and after comparison) by human iPS cell-derived cardiomyocyte sheet transplantation, and to evaluate the safety and tolerability including the combined use of immunosuppressants.

Conditions

Myocardial Ischemia

Keywords

ischemic cardiomyopathy, D017202

Outcome Measures

Primary Outcomes (8)

• The number of patients with improved LVEF

  The number of patients with improved LVEF by echocardiography 26 weeks postoperatively compared with preoperatively.

  26 weeks

• Incidence of adverse events and defects [Safety and Tolerability]

  Regarding adverse events and side effects (of the adverse events, those whose causal relationship with the clinical trial product is determined to be other than "not related" will be treated as side effects.) the number of occurrences and the number of occurrence examples by event and severity will be obtained.

  From postoperative to the end of the observation period (52 weeks)

• Incidence of serious adverse events [Safety and Tolerability]

  Regarding serious adverse events, the number of occurrences and the number of occurrence examples by event and severity will be obtained.

  From postoperative to the end of the observation period (52 weeks)

• Incidence of abnormal vital signs [Safety and Tolerability]

  Regarding changes in vital signs(Body temperature, blood pressure (systolic, diastolic), and pulse rate), summary statistics and changes at each measurement time point will be obtained.

  Before surgery, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks

• Incidence of abnormal general blood tests [Safety and Tolerability]

  Regarding changes in general blood tests(WBC, RBC, Hb, Ht, PLT), summary statistics and changes at each measurement time point will be obtained.

  Before surgery, 1 days, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks

• Incidence of abnormal blood biochemical tests [Safety and Tolerability]

  Regarding changes in blood biochemistry tests(AST(GOT), ALT(GPT), LDH, ALP, BUN, Cre, UA, TG, T-Cho, LDL-Cho, Alb, CK, CK-MB, electrolytes (Na, K, Cl, Ca, iP, Mg), CRP, blood sugar), summary statistics and changes at each measurement time point will be obtained.

  Before surgery, 1 days, 7 days, 14 days, 4 weeks, 13 weeks, 26 weeks, 52 weeks

• Incidence of abnormal tumor marker tests [Safety and Tolerability]

  Regarding changes in tumor marker tests(AFP, CA19-9, CEA, hCG), summary statistics and changes at each measurement time point will be obtained.

  Screening, 13 weeks, 26 weeks, 52 weeks

• Incidence of cardiac function clinical events such as death and hospitalization [Safety and Tolerability]

  With respect to the incidence of cardiac function clinical events such as death and hospitalization, the number of cases in which the causes of death are related to heart disease and those unrelated to heart disease will be determined for cases of death.

  From postoperative to the end of the observation period (52 weeks)

Secondary Outcomes (15)

• Number of Responder patients 26 and 52 weeks after transplantation of this product

  26 and 52 weeks

• Contraction function of the entire left ventricle

  26 weeks

• Left ventricular remodeling (LVESVI)

  26 weeks

• Left ventricular remodeling (LVEDVI)

  26 weeks

• New York Heart Association functional classification

  Before surgery, 26 weeks, 52 weeks

Study Arms (1)

Group of subjects undergoing cell transplantation

EXPERIMENTAL

Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation (only once)

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

Interventions

Human (allogeneic) iPS cell derived-cardiomyocyte sheet BIOLOGICAL

Transplantation

Group of subjects undergoing cell transplantation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic ischemic heart disease
• Patients with Grade III-IV NYHA Functional Classification heart failure
• Patients who are in the state of heart failure despite maximal oral medications including digitalis, diuretics, ACE inhibitors, ARBs, beta-blockers, anti-aldosterone drugs, and oral cardiotonics
• Patients who are 20 years of age or older at the point of consent
• Patients at risk of worsening heart failure despite being under standard surgical treatment (coronary artery bypass surgery, mitral valve angioplasty, left ventricular angioplasty, cardiac resynchronization therapy, and percutaneous coronary intervention) for more than 3 months
• Patients with LVEF (Echocardiography) at rest of 35% or less
• Patients whose informed consent for clinical trial participation can be obtained from the subject himself/herself in writing
• Patients who can continue to visit to the clinical trial site for 52 weeks after obtaining consent, continue to live in Japan, and can be expected to have data collected by NRMD/PMS

You may not qualify if:

• Patients with autoimmune diseases
• Patients with allergies or hypersensitivity to the immunosuppressant used
• Patients with active infections
• Patients who remain in shock due to worsening heart failure
• Patients with irreversible organ failure other than heart
• Patients with malignant tumors
• Patients who are or may be pregnant
• Patients with history of alcoholism or drug addiction within six months from the day of consent
• Patients with allergies or hypersensitivity to animals such as cattle from which the raw materials are derived
• Patients with severe pulmonary hypertension
• Patients within 6 months of completion of other clinical trials at the time of enrollment
• In addition, patients with other cardiovascular abnormalities who are determined to be unfit for this study as per the judgment of the patient enrollment study committee of physicians

Sponsors & Collaborators

• Osaka University: lead
• Cuorips Inc.: collaborator

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 5650871, Japan

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yoshiki Sawa, Ph.D

  Osaka University

  STUDY DIRECTOR

Central Study Contacts

Takuji Kawamura, Ph.D

CONTACT

+81-6-6879-3154; saisentan@tissue.med.osaka-u.ac.jp

Shigeru Miyagawa, PhD

CONTACT

+81-6-6879-3154; miyagawakenkyu@surg1.med.osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 6, 2021
• Study Start: December 2, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)