Dilated Cardiomyopathy Dilated Cardiomyopathy, Heart Failure
Conditions
Interventions
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.
Sponsors
Yamashita Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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%
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart function, QOL | — |
Contacts
Public ContactClinical Development Specialist
iHeart Japan Corporation
Outcome results
None listed