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Clinical trial of multi-layered human iPSC-derived cardiovascular cell sheets (IHJ-301) for dilated cardiomyopathy.

Clinical trial of IHJ-301 for heart failure.

Yamashita Jun

Graduate School of Medicine, The University of Tokyo

7-3-1, Hongo, Bunkyo-ku, Tokyo

clncldvlpmnt@iheartjapan.jp

Clinical Development Specialist

iHeart Japan Corporation

448-5, Kajii-cho, Kamigyo-ku Kyoto-shi, Kyoto-fu

+81-80-2408-5886

clncldvlpmnt@iheartjapan.jp

Recruiting

Oct. 31, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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%

- 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

Both

Dilated Cardiomyopathy

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.

Dilated Cardiomyopathy, Heart Failure

Safety

Heart function, QOL

+81-3-5800-8743

Sept. 19, 2024

No

none