A Japanese startup has said it conducted a clinical trial to transplant a treatment sheet containing cardiac muscle cells derived from human induced pluripotent stem (iPS) cells into a patient with a heart muscle disease.
The surgery to transplant the sheet into the patient, who was diagnosed with dilated cardiomyopathy, was performed at the end of May at the Tokyo Women's Medical University Hospital. The patient has already been discharged from the hospital.
The regenerative medicine startup, iHeart Japan, based in the city of Kyoto, said Monday that the patient will undergo monitoring so that the company can assess the treatment's safety and efficacy.
The startup layered three types of cells, including those of heart muscles and blood vessels. Gelatin particles were added to the layers of the cells to create the round sheet measuring about 4 centimeters in diameter and 1 millimeter in thickness.
When placed on the surface of the heart, the sheet is expected to improve the heart's contractions partly through the functions of exosomes, or vesicles, produced by cells.
The startup plans to expand the clinical trial program gradually after confirming the safety of the sheet in the first three sheet recipients. Up to 10 people are expected to receive the treatment by the end of 2027.
Based on the results of the trials, the company aims to obtain state approval to make and sell the sheet.
Among efforts to treat heart failure using iPS cells, another startup, affiliated with Keio University, is conducting clinical trials to inject iPS-derived cardiac spheroids into patients. The company is monitoring 10 people injected with such spheroids.
And in April this year, a company linked with the University of Osaka applied to the welfare ministry for approval of a treatment using iPS-derived myocardial cells.
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