Heartseed Announces the Presentation of HS-001, an Investigational Stem Cell-Derived Therapy for the Treatment of Advanced Heart Failure at the 71 st Annual Meeting of the Japanese College of Cardiology

Heartseed (Heartseed Inc.), a Tokyo-based biotechnology company developing iPSC-derived cardiomyocytes for heart failure, today announced that the case reports of two patients in the Phase 1/2 clinical trial (LAPiS Study) of HS-001 in combination with coronary artery bypass grafting surgery for advanced heart failure, was presented by the investigator at the 71st Annual Meeting of the Japanese College of Cardiology (JCC) on September 9, 2023.

Dr. Yuki Ichihara, Department of Cardiovascular Surgery, Tokyo Women's Medical University, presented his experience of two patients in the LAPiS study and according to the presentation, the cell transplantation went smoothly, and the immunosuppressants management proceeded without major complications, and improvement in cardiac function was observed.

Dr. Ichihara stated, “Among ischaemic heart failure patients with reduced left ventricular ejection fraction (LVEF), we have experienced that LVEF does not improve after coronary artery bypass surgery, especially in severe cases with little remaining myocardium. In this clinical trial, the initial results suggest that the transplanted cardiomyocytes have engrafted, and I believe that this can be a new treatment method that aims to improve cardiac function by transplanting and replacing cardiomyocytes mainly in areas where there is little viable myocardium.”

The efficacy results of the two cases presented at the congress (pre-transplant baseline and 26-week post-transplant) is shown in the table below.

		First Patient	Second Patient
LVEF (%)	Echo	26 → 28	17 → 38
	MRI	15 → 19	10.8 → 18.0
LVEDV (mL)	Echo	345 → 252 (-27%)	196 → 164 (-16%)
	MRI	431 → 389 (-10%)	265 → 197 (-26%)
Cardiothoracic ratio (%)		63.1 → 60.0	61.6 → 48.3
NT-proBNP (pg/mL)		11,471 → 5,733 (-50%)	5,225 → 817 (-84%)
NYHA functional classification		III → II	III → I

Both patients initially had severe heart failure, as indicated by their low LVEF and enlarged heart size. Both patients showed reverse remodeling, improvements in heart function, NYHA functional classification and biomarker at 26-week.

Currently, four patients were dosed in the LAPiS trial. Regarding safety, there have been no events that would be problematic for the continuation of the clinical trial. Heartseed continues patient enrollment in the LAPiS trial.

For details: https://www.heartseed.jp/en/index.html

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Contact information

Kikuo Yasui,
COO, Heartseed Inc.
Tel: +81-3-6380-1068
Email: kikuo.yasui@heartseed.jp