Date: 2017-11-29
Type of
information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Chugai Pharmaceutical (Japan) Twocells (Japan)
Product: gMSC®1
Action
mechanism:
- cell therapy. gMSC®1 is a tissue-engineered medical product currently developed by Twocells and was prepared for the regenerative chondrogenesis using synovium-derived mesenchymal stem cell in collabolation with Osaka University and Hiroshima University. This product is a scaffold-free allogeneic 3D artificial tissue of mesenchymal stem cell provided by TWOCELLS with their own technologies and serum-free medium (STK®1 and STK®2), which is expected to provide an effective treatment for cartilage regeneration.
- Chugai has joint development and exclusive distribution rights of gMSC®1 in Japan, and also, reserves preferential negotiating rights for oversea. In addition, Chugai shall be responsible for the application for approval, and marketing and clinical studies after the initial approval.
Disease: symptomatic articular cartilage defects or osteochondritis dissecans in the knee
Therapeutic
area: Bone diseases - Regenerative medicine
Country: Japan
Trial
details:
Latest
news:
- • On November 29, 2017, Chugai Pharmaceutical and Twocells announced that the first patient has been performed surgery in the Phase III comaparative trial of “gMSC®1”, a regenerative cellular medicine for chondrogenesis in the knee. Twocells has licensed Chugai Pharmaceutical for gMSC®1. The object of this study is to compare the safety and efficacy of gMSC®1 versus microfracture, as standard treatment, in patients with symptomatic articular cartilage defects or osteochondritis dissecans in the knee, with or without complication e.g. ligament injury and meniscus injury.Chugai will further collaborate with Twocells to accerelate the development of gMSC®1 successfully and file a new drug application as quickly as possible.
Is
general: Yes
