Monday, 11 February 2013

Cerebral Palsy clinical trials to be commenced in Korea

RNL BIO CO LTD  announced a couple of days ago that it has applied to the Korean Food and Drug Administration (KFDA) an application to receive approval for phase II and phase III human clinical trials, involving their stem cell therapy for people suffering from cerebral palsy. Purpose of the study is to examine the safety of their drug, called Astrostem, over a period of 11 months.

The trial will be conducted at the Kyung Hee University Hospital at Gangdong and the Bethesda Hospital and a total of 45 patients are expected to enrol. Astrostem is a stem cell-based treatment involving infusions of mesenchymal stem cells which  are derived from adipose tissue (fat).

The drug has already been tested on humans in a 2011 phase 1 clinical trial and the safety results were positive. Specifically, during the phase I trial various doses of Astrostem were first tested on a mouse model. None of the mice presented with any adverse effects or cancer activity, even the ones administered with the highest doses. Astrostem was then given to 8 male patients who had suffered a spinal cord injury 12 months or less before receiving the treatment and during the 3 month follow up no adverse effects were reported.


Picture showing the human cerebrum
Human cerebrum (stained in red), the brain area mainly affected by cerebrum palsy

The company has high hopes that by 2014 Astrostem will be commercially available in Korea, and later in other countries as well.

The Korean company has also completed a Phase II clinical trial for Osteoarthritis and is near to the completion of a trial on Buerger's Disease.

It is worth mentioning that a few weeks ago, the South Korea government had announced that it will take legal action against RNL BIO, accusing the company for arranging illegal stem cell treatments. You can read more about that story here.


Cerebral Palsy refers to a group of motor disorders involving brain and nervous system functions. Cerebral refers to the cerebrum, which is the area mainly affected, although other brain areas like the cortex may be involved as well. The condition is usually caused by brain injuries occurring during pregnancy, childbirth or after birth and up to the age of three.


Informational video about Cerebral Palsy


Updates:




Reference
Ra, J., Shin, I., Kim, S., Kang, S., Kang, B., Lee, H., Kim, Y., Jo, J., Yoon, E., Choi, H., & Kwon, E. (2011). Safety of Intravenous Infusion of Human Adipose Tissue-Derived Mesenchymal Stem Cells in Animals and Humans Stem Cells and Development, 20 (8), 1297-1308 DOI: 10.1089/scd.2010.0466

3 comments:

  1. Stem cells provide an intriguing form of treatment for people with cerebral palsy. Dr. Michael Fehlings of the University of Toronto says that stem cells can help repair damaged brain cells or grow new ones to replace damaged cells. However, there is still a lot of research to be done on this treatment, and many clinics outside of the U.S. that offer stem cell treatments face charges of obtaining stem cells illegally. We hope to see significant progress in this area as the current surgical options for cerebral palsy patients are limited and very expensive.

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  2. So what is the problem! sometimes breaking the law to get things done is the only way for results. I have a 5yr old son with cerebral palsy and his window of opportunity is narrowing for stem cells to properly work. I just recently attended a seminar at sick kids hospital in Toronto. What they are saying all sounds great, but the million dollar question is when! I am seriously thinking of South Korea for treatment. Their is to much red tape here in Canada and not enough funding. Though we have some of the best Doctors and scientists in the world, we seem to always be that one step behind everyone else. So I say good for breaking the law, at least they got somewhere

    ReplyDelete
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    ReplyDelete

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