Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for dilated cardiomyopathy

JRCT ID: jRCT2053230136

Registered date:25/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dilated cardiomyopathy
• Date of first enrollment: 25/11/2023
• Target sample size: 4
• Study type: Interventional
• Intervention(s): Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation

Outcome(s)

Primary Outcome

Number and frequency of the following items that occur up to 52 weeks after transplantation
1) Adverse events and malfunctions
2) Serious adverse events
3) Vital signs, general blood tests, blood biochemistry tests, tumor marker tests and safety-related evaluations
4) Incidence of cardiac clinical events such as death and hospitalization

Secondary Outcome

1) Contractile function of the left ventricle
2) left ventricular remodeling
3) Severity of heart failure
4) Exercise tolerance
5) Blood test value trends
6) Cumulative number of rejection reactions
7) Number of patients judged to have improved at 26 or 52 weeks after transplantation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) dilated cardiomyopathy
2) NYHA class 3,4
3) Patients who can not expect symptomatic improvement with standarid treatment for taget disease.To be recognized by the third party committee with experts.
4) Patients who have not seen improvement in cardiac function more than 3 months after standard surgical treatment and who are at risk of worsening heart failure
5) Ejecion franction<40%
6) Patients who can obtain written consent from the subject to participate in the clinical trial.
7) Patients who can continue to visit the study site for 52 weeks after transplantation

Exclude criteria

1) Autoimmune disease
2) Allergic or hypersensitive to the immunosuppressant
3) Severe infection
4) Persistent shock due to worsening heart failure
5) Irreversible organ failure other than heart
6) Malignancy
7) Pregnancy
8) Alcoholic or drug addiction in recent six months
9) Allergies or hypersensitivity to animals from which raw materials used
10) Severe pulmonary hypertension
11) Within 6 months after participating in the clinical trial
12) Patients deemed unsuitable as subjects

Related Information

• Primary Sponsor: Miyagawa Shigeru
• Source(s) of Monetary Support: Japan Agancy for Medical Research and Development