Read this, there phase 3 tests come out this month.
S. Korea Leads in Commercial Stem-Cell Therapies
South Korea has taken in the lead in commercializing the medical use of stem cells with three firms receiving government approval for stem-cell treatments during the last year.
Last week the Korea Food and Drug Administration (KFDA) approved Medipost’s Cartistem, a stem cell treatment for damaged cartilage, and Anterogen’s Cupistem, a stem cell treatment for anal fistula, making them the world’s second and third authorized stem cell procedures.
The first came in July 2011 when FCB-Pharmicell’s Hearticellgram-AMI won approval from the KFDA to become the world’s first stem cell treatment for heart attack victims.
S. Korea officially embraced stem-cell therapy as an important future industry last September when President Lee Myung-bak pledged a series of regulatory reforms to ease clinical and licensing requirements and an investment of about 100 billion won ($89 million) in stem cell research in 2012 alone.
Lee said in his biweekly radio address that “the government has decided to foster the stem cell industry as a core new growth engine following the footsteps of the IT industry.”
FCB-Pharmicell’s Hearticellgram-AMI injects stem cells directly into the heart where they seek out damage and regenerate the appropriate types of cardiac tissue. In clinical trials in 40 patients over the past five years the procedure increased the heart ejection fraction — the share of blood ejected from the heart’s right and left ventricles when they contract — of all patients by an average of 5.93%. By comparison 40 patients who didn’t receive the treatment had a rise of only 1.76%.
Medipost’s Cartistem uses stem cells from a genetically similar donor rather than stem cells taken from the patient and is, therefore, the world’s first allogeneic stem cell treatment. The strategy facilitates mass-production and more consistent efficacy for the 15% of the world’s population suffering from cartilage and joint damage like degenerative arthritis and rheumatoid arthritis.
Forty-two of the 43 patients who participated in a Cartistem clinical trial confirmed improvement after 48 weeks, according to Medipost.
Anterogen’s Cupistem uses a patient’s own stem cells from fatty tissue to treat anal fistula in Crohn’s disease. The fistulous opening closed completely for 27 of the 33 patients who were injected witih Cupistem in a clinical trial. About 10,000 to 15,000 patients suffer from Crohn’s disease in Korea. About 20 to 40% developed the Crohn’s anal fistula complication.
CHA Bio & Diostech has developed three of only four embryonic stem cell treatments approved for clinical trials in the entire world. American biotech firm Geron’s embryonic stem cell treatment for spinal cord injuries was the first. But Geron announced in November that it is “dropping its entire program owing to financial concerns.” The therapy was then in a phase 1 trial. The other three are CHA Bio & Diostech’s products.
CHA Bio & Diostech and the U.S. firm Advanced Cell Technology recently completed a phase 3 trial of one of its three embryonic stem cell treatments using retinal pigment epithelial cells derived from human embryonic stem cells to treat blind patients with Stargardt’s Macular Dystrophy. The company announced that the trial enjoyed good results and is expecting KFDA approval in January or February.
Korea already ranks fourth in the number of stem cell patients, after the United States, Japan and the United Kingdom, according to data from the Ministry of Health and Welfare. It sees Korea as being in the position to take the lead, but must make massive investments on a par with the top nations.
The 100 billion won ($89 mil.) pledged by President Lee is only a fraction of the $1 to $2 billion the US devotes annually to stem cell research and development. Japan invests about 75 billion yen ($1 bil.) a year.
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