Korea develops two new stem cell treatments

Korea is regaining its footing as a stem cell research powerhouse, as the world’s second batch of stem cell treatments were approved yesterday by the Korean Food and Drug Administration.

The KFDA approved two stem cell treatments - Medipost Inc.’s Cartistem, a stem cell treatment for damaged cartilage and Anterogen’s Cupistem, a stem cell treatment for anal fistula - registering both treatments as the world’s second and third stem cell treatments.

The world’s first stem cell treatment, Hearticellgram-AMI, designed to help treat heart attacks, was also developed by a Korean biotechnology firm, FCB-Pharmicell, and was approved in July last year.

Medipost Inc.’s damaged cartilage treatment Cartistem, was produced using the allogeneic stem cell, which comes not from the patient but from a donor that has a genetically similar but not identical stem cell, making it the world’s first allogeneic stem cell treatment.

The other two stem cell treatments use autologous stem cells, which are from the patient’s own stem cells.

Allogeneic stem cells are advantageous because they have a higher mass-production potential and consistent treatment efficacy.

Cartistem, which is manufactured by cultivating mesenchymal stem cells from human umbilical cord blood, can treat rheumatoid arthritis or knee cartilage injuries.

According to Medipost Inc., Cartistem is expected to provide new treatment opportunities to concerned patients. It said that about 15 percent of the world’s population is reportedly suffering from cartilage and joint damage such as degenerative arthritis and rheumatoid arthritis. It added that the percentage has been increasing as the population ages and more young people are involved in active sports.

Currently, treatments such as drug therapy, arthroscopy and artificial joint surgery are being used as treatment for cartilage defects but they reportedly “fail to address the root cause” of the problem.

Forty-three patients participated in a clinical trial with Cartistem, according to Medipost Inc., and after 48 weeks, 42 patients were able to confirm improvements.

On the other hand, Anterogen’s Cupistem is a stem cell treatment that uses a patient’s own stem cells from fatty tissue to treat anal fistula in Crohn’s disease.

The problem is one of the complications for patients suffering from Crohn’s disease, which is a form of inflammatory bowel disease. Crohn’s anal fistula refers to holes in the skin around a patients’ anus.

In Korea, there are about 10,000 to 15,000 patients who are currently suffering from Crohn’s disease, according to Anterogen, and among them about 20 to 40 percent developed the Crohn’s anal fistula complication.

When 33 patients underwent a clinical trial with Cupistem, the fistulous openings completely closed for 27 patients eight weeks after the injection.

Both Medipost Inc. and Anterogen said the two products will be launched after completing administrative procedures such as insurance pricing.

Meanwhile, the KFDA said it will continue its efforts to shorten the manufacturing process for biotechnological products while also improving safety.

By Yim Seung-hye [sharon@joongang.co.kr]