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Nature Cell applies for P3 clinical trials
  • By Lee Han-soo
  • Published 2018.06.01 15:43
  • Updated 2018.06.01 15:43
  • comments 0

Nature Cell said Friday that Biostar, its stem cell research institution, has applied for phase 3 clinical trials for Jointstem, a stem cell therapy for degenerative arthritis, to the Ministry of Food and Drug Safety.

The therapy is an autologous adipose-derived mesenchymal stem cell injection, developed by Nature Cell.

The company will run its clinical trials on 230 patients suffering from Kellgren & Lawrence (K-L) Grade 3 or higher at 13 local hospitals, including Gangnam Severance Hospital and Gangdong Kyunghee University Hospital.

Biostar plans to assign participants into two groups randomly -- 115 patients taking Jointstem and 115 patients receiving placebos. The trial will set the visual analog scale (VAS) survey, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and MRI images of the damaged cartilage points as the primary evaluation indexes and follow up on the patients for 24 weeks.

If approved, the company plans to start recruiting patients by the end of this year.

The company has confirmed a significant improvement in the WOMAC and VAS indexes through a phase 2b clinical trial. Six months after the treatment of Jointstem, the patients’ WOMAC average score went down by 55.23 percent and VAS, by 52.06 percent.

“The company plans to finish administering the treatment to participants by next year,” said Ra Jeong-chan, CEO of Nature Cell and Biostar.

corea022@docdocdoc.co.kr

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