RNL Bio Co. Ltd, a biotechnology company, engages in the research and development of stem cell therapies and natural material screening techniques in South Korea, has submitted an IND (Investigational New Drug, under study) application with the authority Korean Food and Drug Administration (KFDA) to initiate a phase II clinical trial and III announced with the stem cell-derived drug RNL Astrostem, the company of patients with cerebral palsy to be tested. The purpose of this study is to test the effectiveness of the final stem cells to treat cerebral palsy in 45 patients over 11 months.
The study aims at the Hospital of the University of Kyung Hee are performed at the hospital and THE Bethesda Hospital.
The phase I study to confirm the safety of RNL Astrostem has already been completed. This included testing the toxicity and tumorigenicity was excluded. The study was conducted at the Clinical Research Institute of Seoul National University carried out. Moreover, it was with the phase I study, the safety of infusierten with IV stem cells be confirmed, as published in a leading in the journal Stem Cells and Development post ("Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans", February 2011) was presented. A number of successful security studies, scientists could provide significant evidence to suggest that the efficacy potential of stem cells in the treatment of cerebral palsy. Moreover, a case report, with significant improvements in the results in another internationally known journal published. RNL BIO is the opinion that it will be possible with the successful trials and with the approval of the KFDA, RNL Astrostem to commercialise by 2014, bringing the possibility of treating this incurable disease in childhood, disease control with current technologies only may be, will be revolutionized.
The cerebral palsy is caused by a non-progressive brain damage by single or multiple disorders of the nervous and muscular system and leads to movement disorders and disturbances in sensory integration. According HIRA (Health Insurance Review and Assessment Service), the prevalence of cerebral palsy 3.5 per 1000 male to 2.8 per 1000 female children., With an average of 3.2 per 1000 children It is expected that the prevalence increases due to the reduction of the number of premature deaths still.
In the clinical study, the investigators used different methods to test the efficacy: K-ABC: Kaufman Assessment Battery for Children, Gross Motor Function Measure (GMFM), box-and-block test, Modified Ashworth Scale (MAS), finger-tapping test, Brain SPECT and MRI.
Dr JC Ra, chairman of RNL BIO Stem Cell Technology Institute, said, "Our job is to find cures for incurable diseases, such as for the horrible disease cerebral palsy children by car genetic stem cell technology."