Clinical trial of IHJ-301 for heart failure.

JRCT ID: jRCT2033240447

Registered date:31/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dilated Cardiomyopathy
• Date of first enrollment: 31/10/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): One of multi-layered human iPSC-derived cardiovascular cell sheets shall be applied to the surface of left ventricle under immunosuppression with Tacrolimus, Mycophenolate Mofetil and Prednisolone.

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Heart function, QOL

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

- Patients with dilated cardiomyopathy
- Patients with no improvement by drug therapy (digitalis, diuretics, ACE inhibitors, ARBs, beta-blockers, anti-aldosterone drugs, SGLT2 inhibitors, ARNI, oral inotropic drugs, etc.)
- Patients with no improvement by non-drug therapy (Cardiac Resynchronization Therapy, etc.)
- Patients in New York Heart Association Class III or II with a history of III
- Patients with LVEF as greater than 15% and less than 40%

Exclude criteria

- Patients with lamin A gene mutation
- Patients with autoimmune diseases
- Patients with a history of severe allergies
- Patients with active infections
- Patients with malignant tumors
- Patients with poorly controlled diabetes
- Patients with ischemic heart disease
- Patients who cannot take immunosuppressants
- Patients with valvular heart disease, aortic aneurysm, or aortic dissection
- Patients with liver cirrhosis
- Patients on dialysis

Related Information

• Primary Sponsor: Yamashita Jun