Cellumed Confirms Safety and Efficacy of Bone Graft Material 'Rapugen BMP2'... "Published in Journal of Korean Neurosurgical Society"
[Asia Economy Reporter Hyunseok Yoo] Clinical results of Cellumed's bone graft material ‘Rapugen BMP2’ have been published in an SCI-level academic journal.
Cellumed announced on the 4th that the clinical research results on the spinal application of ‘Rapugen BMP2,’ a bone graft material containing bone morphogenetic protein, were published in the online edition of the Journal of Korean Neurosurgical Society, an SCI(E)-level journal.
Over the past 10 years, Cellumed has conducted research projects under the Ministry of Trade, Industry and Energy’s major initiative, the World Market Pioneering 10 Core Materials (WPM) project, developing the next-generation bone graft material ‘Rapugen BMP2’ and conducting this clinical study. ‘Rapugen BMP2’ is the second bone graft material worldwide and the first in Korea to be approved containing animal cell-derived bone morphogenetic protein.
With safety and efficacy confirmed through this clinical study, it is expected that injecting it into defect areas such as spinal injuries and dental damage will accelerate bone fusion rates.
The clinical study was conducted at six university hospitals: Severance Hospital in Sinchon, Seoul National University Bundang Hospital, Inha University Hospital, Korea University Guro Hospital, Hallym University Sacred Heart Hospital, and Soonchunhyang University Bucheon Hospital. The paper was written based on the results of a multicenter randomized clinical trial involving patients experiencing pain due to lumbar disc disease.
According to the accepted paper, a relatively high fusion rate was confirmed at an early stage after applying ‘Rapugen BMP2’ clinically. By demonstrating the possibility of successful rehabilitation from the early stages of the disease, the safety of ‘Rapugen BMP2’ has been recognized and is attracting attention.
A company official stated, “We already obtained approval from the Ministry of Food and Drug Safety for ‘Rapugen BMP2’ as a dental bone graft material through dental clinical trials in 2013,” adding, “Based on the successful spinal clinical results, we have applied for approval as an orthopedic bone graft material with the Ministry of Food and Drug Safety.”
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He continued, “Once approval is obtained for orthopedic use following dental use, sales related to ‘Rapugen BMP2’ are expected to expand further,” adding, “In particular, as the number of patients suffering from spinal diseases is increasing, demand is expected to be greater than that for dental use.”
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