Metcela

About Metcela

Metcela is a clinical-stage biotechnology company founded in March 2016, specializing in the research and development of regenerative cell therapies for cardiovascular diseases. The company was co-founded by Dr. Takahiro Iwamiya and Kenichi Nogami. The foundation of the company was to commercialize the results of Dr. Iwamiya's doctoral research on cardiac fibroblasts at Tokyo Women's Medical University. Nogami brought experience from an investment bank and a start-up to his roles as co-founder and CEO.

Metcela's core technology centers on a specific type of cardiac fibroblast known as VCAM-1-positive Cardiac Fibroblast (VCF). The company's lead product, MTC001, is a combination of these autologous (patient-derived) cardiac cells and a proprietary catheter delivery system for minimally invasive administration. This therapy is designed to treat chronic heart failure by promoting the regeneration of heart tissue. Pre-clinical studies have shown that VCF can stimulate cardiomyocyte proliferation and repair damaged tissues by forming new lymphatic vessels (lymphangiogenesis). The autologous nature of the therapy helps to avoid immune rejection, a significant advantage in cardiac treatments. However, in 2024, the clinical trial and development for MTC001 were halted due to significant challenges in maintaining a stable supply of the investigational product.

In April 2022, Metcela acquired Japan Regenerative Medicine Co., Ltd. (JRM), which is developing JRM-001, an autologous cardiac stem cell-based therapy for pediatric congenital heart disease, specifically single ventricle disease. This acquisition expanded Metcela's portfolio to include treatments for both adult and pediatric heart conditions. A Phase 3 clinical trial for JRM-001 that was suspended due to manufacturing issues is set to resume.

The company's business model involves a hospital-to-manufacturing site-to-hospital workflow. A small piece of cardiac tissue is biopsied from the patient, transported to a facility for cell culturing and formulation, and the final product is delivered back to the hospital for administration. Metcela has raised a total of $36.7 million over five funding rounds, with its latest Series C round closing in June 2022. The company collaborates with partners like Japan Lifeline for the development of its specialized catheter and has received grants from organizations such as the Japan Agency for Medical Research and Development (AMED).