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

Phase 1

• Conditions: Ischemic cardiomyopathy; D017202

• Registration Number: JPRN-jRCT2053190081
• Lead Sponsor: Miyagawa Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Ischemic cardiomyopathy
2) NYHA class III, IV
3) Patients who can not expect symptomatic improvement with standard treatment for target disease. To be recognized by the third party committee with experts.
4) Ejection fraction <= 35%

Exclusion 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) Maignancy
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified