Cell Therapy Products
An allogeneic stem cell therapy to treat complex perianal fistulas in patients with Crohn’s disease. Received EU marketing authorisation in March 2018.
A cellular therapeutic agent containing allogeneic human umbilical cord blood-derived mesenchymal stem cells, indicated for the treatment of knee cartilage defects such as traumatic articular cartilage, degenerative arthritis and rheumatoid arthritis. Approved for marketing by South Korea’s Ministry of Food and Drug Safety in January 2012.
An autologous intracoronary bone marrow-derived mesenchymal stem cell injection for the treatment acute myocardial infarction. Approved for marketing by South Korea’s Food and Drug Administration in July 2011.
An autologous adipose derived mesenchymal stem cell treatment to reduce inflammation and regenerate damage joint tissues, indicated for the treatment of Crohn’s fistula. Approved for marketing by South Korea’s Food and Drug Administration in July 2012.
An autologous dermal fibroblast cell-based therapy approved in S. Korea in 2010 for the treatment of depressed acne scars.
Holoclar is a cell therapy based on autologous cultures of limbal stem cells. It regenerates a functional corneal epithelium allowing recovery of visual acuity. Holoclar is indicated for the treatment of moderate to severe limbal stem cell deficiency due to ocular burns. Granted conditional marketing authorization by the European Commission in February 2015.
An allogeneic cell therapy for deep second degree burns and diabetic foot ulcers. Approved in S. Korea for burns in 2005 and diabetic foot ulcers in 2010.
An autologous keratinocyte based cell therapy for the treatment of 2nd degree burns. Approved in S. Korea in 2006.
A hydrogel-type allogeneic keratinocyte therapy product for the treatment of second-degree burns. Approved in S. Korea in 2015.
LaViv is an autologous fibroblast-based cell therapy. Approved by the U.S. FDA in January 2011 for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.
An autologous bone marrow mesenchymal stem cell therapy approved in S. Korea in 2014 for the treatment of ALS.
An autologous mesenchymal stem cell for the treatment of connective tissue disorders. Approved in S. Korea in 2010.
Autologous cell therapy approved in S. Korea in 2018 for the treatment of under eye wrinkles.
Spherox (formerly Chrondosphere)
A product containing spheroids of human autologous chondrocytes for use in cartilage defects. Marketed in Europe as of 2017; marketed in Germany since 2007.
A mesenchymal stem cell therapy approved in Japan in December 2018 for the treatment of spinal cord injury.
STEMPEUTICS RESEARCH PVT
An ex-vivo cultured adult allogeneic mesenchymal stromal cell therapy for the treatment of Critical Limb Ischemia. Conditionally approved in India in 2017.
JCR PHARMACEUTICALS CO LTD, LICENSEE OF MESOBLAST LTD
TEMCELL is an allogeneic mesenchymal stem cell product indicated for the treatment of acute radiation injury, chronic obstructive pulmonary disease, Crohn’s disease, acute graft-versus-host disease, Type I diabetes and myocardial infarction. Approved by the Japanese Ministry of Health, Labour and Welfare for acute graft-versus-host disease in October 2015 and conditionally approved in Canada & New Zealand