Korea develops two new stem cell treatments

Korea develops two new stem cell treatments




Jan 20,2012







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]







한글 관련 기사 [중앙일보]



다른 사람 줄기세포로 만든 관절염 치료제 나왔다



수술 앞둔 퇴행성 환자에 적용

이르면 다음달 세계 첫 시판



다른 사람의 줄기세포를 뽑아서 만들었다가 필요한 환자에게 투여하는 타가(他家) 줄기세포 치료제가 세계 처음으로 국내에서 시판 허가를 받았다.



　식품의약품안전청은 19일 메디포스트가 퇴행성 관절염 환자를 위해 개발한 타가 줄기세포 치료제 ‘카티스템’을 시판 허가했다고 밝혔다. 식약청은 또 안트로젠이 신청한 자가(自家) 줄기세포 치료제 ‘큐피스템’도 시판을 허가했다. 이 약은 자신의 지방세포에서 추출한 줄기세포를 이용한다.



　이에 따라 지난해 국내 업체가 개발한 심근경색 치료제 ‘하티셀그램-AMI’가 세계에서 처음 줄기세포 치료제로 허가받은 데 이어 세계 두 번째 줄기세포 치료제도 국내에서 나오게 됐다.



　타가 줄기세포 치료제는 미리 만들어 놓았다가 여러 사람에게 사용할 수 있어 상업화에 유리하다. 그러나 투여 받은 환자의 몸이 줄기세포를 적(敵)으로 간주해 면역 거부반응을 일으킬 가능성도 있다. 이번에 시판 허가된 ‘카티스템’은 노화나 반복적인 외상으로 인한 골(骨)관절염 환자의 닳거나 손상된 무릎연골을 치유하는 데 사용 가능하다. 식약청 바이오의약품정책과 김유미 과장은 “퇴행성 관절염 환자가 인공관절 수술을 받기 전에 신약을 적용해볼 수 있을 것”이라며 “이런 환자가 국내에 약 1만~10만 명에 달한다”고 추정했다.



　‘큐피스템’은 희귀병인 크론병으로 인한 누공 치료제다. 누공은 만성 염증성 장(腸)질환인 크론병 환자에게서 나타나는 합병증으로 염증으로 인해 대장과 항문 주변에 생긴 구멍이다. 환자 33명을 대상으로 임상시험을 한 결과, 82%(27명)에서 누공이 완전히 치료된 것으로 나타났다. 국내엔 약 5000~1만 명의 크론병 환자가 있는데 이 중 20%가량이 누공 증상을 겪고 있다. 1~2개월 내에 시판될 예정인 ‘카티스템’과 ‘큐피스템’은 1회 투여당 각각 600만원과 300만원 이상의 비용이 들 전망이다.