News

– Utilizing System Support to Accelerate Early Commercialization –
 
Human Life CORD Japan Inc. (President and CEO: Masamitsu Harata, Headquarters: Chuo-ku, Tokyo, Japan, hereinafter referred to as “Human Life CORD”), a pioneer in the development of regenerative cell therapies using umbilical cord-derived mesenchymal stromal cells (hereinafter referred to as “UC-MSCs”), announced today that its investigational product HLC-001, composed of umbilical cord-derived MSCs and under development for the treatment of non-infectious pulmonary complications (NIPCs) after hematopoietic stem cell transplantation, was designated as a “Regenerative Medical Product for Rare Diseases” by the Ministry of Health, Labour and Welfare (MHLW) on August 7, 2025.
(MHLW official announcement: https://www.mhlw.go.jp/content/11120000/001178353.pdf)
 
High Unmet Medical Need in NIPCs
NIPCs occur in approximately 30% of patients after transplantation. While steroids and various immunosuppressants are used for treatment, responses are often poor. Once steroid resistance develops (no improvement in condition despite appropriate steroid therapy), there are no other effective treatment options, creating an urgent need for the development and implementation of new therapies.
 
Development Status of HLC-001
HLC-001, a regenerative medical product consisting of human umbilical cord-derived MSCs developed by the Human Life CORD, demonstrated a favorable safety profile and trends toward improved survival rates and respiratory function in a Phase II clinical trial for NIPCs. These results were published in July 2025 in the International Journal of Hematology.
 
About the “Regenerative Medical Product for Rare Diseases” Designation System
This system allows the MHLW to designate regenerative medical products for serious diseases affecting fewer than 50,000 patients in Japan that have high medical necessity and development potential. Designation enables various forms of support, including development cost subsidies, priority consultation and review for clinical trial and marketing approval, and extended re-examination periods (up to 10 years).
The program aims to accelerate the development of innovative regenerative medical products in the rare disease field and deliver them more quickly to patients in need.
This system allows the MHLW to designate regenerative medical products for serious diseases affecting fewer than 50,000 patients in Japan that have high medical necessity and development potential. Designation enables various forms of support, including development cost subsidies, priority consultation and review for clinical trial and marketing approval, and extended re-examination periods (up to 10 years).
The program aims to accelerate the development of innovative regenerative medical products in the rare disease field and deliver them more quickly to patients in need.
 
Comment from Masamitsu Harata, President & CEO
“This designation marks a decisive step toward delivering a new life-saving option for patients suffering from NIPCs. Our Phase II clinical trial clearly demonstrated safety and promising signs of clinical efficacy, and we are committed to bringing these results to commercialization. We will fully leverage system support, work closely with partner companies, and accelerate discussions with regulatory authorities to shorten the development timeline and deliver this treatment to patients as quickly as possible.”
  
[Contact for Media Inquiries]
Public Relations, Human Life CORD Japan Inc.
Attn: Yuki Hayashi
E-mail: info@humanlifecord.com / Tel: +81-80-4671-0405