South Korea’s government drug agency cleared the way Thursday for commercial sales of what it called the world’s first approved medicine using stem cells collected from other people.
“Cartistem is… the world’s first approved allogeneic (taken from different individuals of the same species) stem cell drug, that can offer new opportunity for treatment of patients with degenerative arthritis,” the administration said in a statement.
Medipost said 27 billion won ($23.8 million) from private investors and government funds had been invested to develop Cartistem since 2001. The drug can be injected into a patient’s knees via surgery.
Clinical trials have been under way in the United States since last year, the statement said.
Two of the world’s top 10 drugmakers are in talks to seek a worldwide licence to make the drug, a Medipost spokesman told AFP, adding that final trials involving a large number of people would likely begin in the US in 2015 (…)
Cartistem, developed by Seoul-based Medipost, will help regenerate knee cartilage using stem cells developed from newborns’ umbilical cord blood, the Korea Food and Drug Administration said.
“Cartistem is… the world’s first approved allogeneic (taken from different individuals of the same species) stem cell drug, that can offer new opportunity for treatment of patients with degenerative arthritis,” the administration said in a statement (…)
CARTISTEM has been developed to treat damaged articular cartilage on knee as a result of acute traumatic injury or more chronic conditions such as osteoarthritis (OA – also known as degenerative arthritis).
Clinical trials Phases I, II and III have all been successfully completed for CARTISTEM demonstrating its efficacy on knee cartilage regeneration. In the clinical trials, single intra-articular (joint) application of CARTISTEM regenerated articular cartilage on the applied area of the knee.
At present, Korea-FDA assesses a Biologics License Application (BLA) for CARTISTEM. Once approved, CARTISTEM will become available as the World’s first hUCB-MSC derived adult stem cell drug for treating osteoarthritis and will be marketed in Korea in association with Dong-A pharmaceuticals (link to Dong-A’s Pharm’s CARTISTEM page).
CARTISTEM has also received US FDA clearance to conduct Phase I/IIa clinical trials in the US.
from http://www.mysinchew.com/node/69253 , http://www.timeslive.co.za/world/2012/01/19/south-korea-approves-stem-cell-drug , http://www.medi-post.com/sp_5_1.asp
The world’s first stem-cell treatment was authorized for sale in Korea last year and two more treatments using the new technology have now also received the green light.
The Korea Food and Drug Administration on Thursday said it approved Cartistem developed by Medipost for the treatment of damaged cartilage and Cupistem, an anal fistula drug by Anterogen.
Cartistem uses stem cells from other people to regenerate knee cartilage damaged by overuse or old age. But Cupistem uses patients’ own stem cells from fatty tissue to treat anal fistula in Crohn’s disease, which is a type of inflammatory bowel disease that can affect any part of the gastrointestinal tract from mouth to anus.
The companies say both drugs are ready for sale immediately.
In July last year, the world’s first stem-cell treatment Hearticellgram-AMI was developed by Korean biotechnology firm FCB-Pharmicell to treat the acute myocardial infarction. The drug went on sale in September and was prescribed 100 times last year.
While countries around the world are racing to gain a firm share of the burgeoning market for stem-cell treatments, 13 other stem-cell treatments for ailments like senility and damaged vertebrae are undergoing clinical trials in Korea.