News

~ Non-clinical PoC achieved; preparations underway for early transition to the clinical stage ~

Human Life CORD Japan Inc. (President & CEO: Masamitsu Harata; Headquarters: Chuo-ku, Tokyo; hereinafter HLC”), aiming to become the world’s first to commercialize umbilical cord-derived mesenchymal stromal cells (UC-MSCs) as regenerative medicine products, today announced that it has added Chronic Lung Disease of Infancy (CLD) as a new target indication to its development pipeline, further accelerating its growth strategy.

Since 2020, Associate Professor Tokiko Nagamura (The Institute of Medical Science, The University of Tokyo) and Professor/Research Director Fumihiko Namba (Department of Pediatrics, Saitama Medical Center, Saitama Medical University) have been conducting research on animal models of this disease, with HLC positioned as the commercialization partner. Based on the recent acquisition of data demonstrating the efficacy of UC-MSCs, we are now preparing to initiate clinical trials at an early stage.

Background
Chronic Lung Disease of Infancy (CLD) is a severe respiratory disorder that commonly affects preterm infants. Current treatment is limited to symptomatic approaches such as oxygen supplementation and respiratory management, with no fundamental cure available. Despite being a disease with high unmet medical needs worldwide, development of novel therapies has been slow.

HLC has been conducting clinical development of UC-MSCs (development code: HLC-001) targeting non-infectious pulmonary complications (NIPCs) after hematopoietic stem cell transplantation, and Phase II trials have already shown promising signs of efficacy. These findings support the potential of UC-MSCs as a novel treatment option for CLD, which also involves pulmonary inflammation and tissue injury.

Furthermore, our initiative to utilize umbilical cords—normally discarded after childbirth—as a valuable resource for cell therapy represents the creation of a life-sustaining cycle, holding great societal significance. Guided by our philosophy, “Cords of life, leading the future,” we are committed to advancing regenerative and cell medicine and realizing a sustainable healthcare society.

About Chronic Lung Disease of Infancy (CLD)
CLD occurs at high frequency in extremely low birth weight infants (<1,500 g) and very low birth weight infants (<1,000g), particularly particularly those requiring mechanical ventilation or high-concentration oxygen therapy. While advances in medical technology have improved survival rates, the proportion of preterm infants has been increasing. However, neonates born with immature lungs remain highly susceptible to inflammation and injury, leading to impaired lung development and long-term reduction of respiratory function. Even beyond the neonatal period, respiratory failure may persist, necessitating ongoing oxygen supplementation or mechanical ventilation, with serious consequences for developmental outcomes.

Comment from Masamitsu Harata, President & CEO
“CLD is a serious complication for extremely and very low birth weight infants, and there is no established effective treatment worldwide. Current therapies, including steroids, are symptomatic only, offering no fundamental solution. UC-MSCs are expected to contribute to slowing disease progression and improving function through multiple mechanisms, including anti-inflammatory effects, tissue repair, and promotion of lung development. Moreover, based on the favorable safety profile demonstrated in previous clinical trials, they are believed to have very high compatibility in the field of neonatal and pediatric diseases.
This addition to our pipeline is an important step in extending the application of UC-MSCs into pediatric medicine, built upon the research achievements accumulated by HLC and collaborating investigators. We will continue to drive development based on robust scientific evidence and build an internationally competitive product portfolio by establishing a sustainable cell therapy ecosystem.”

[Press Release PDF] Adding CLD to the Pipeline