The pharmaceutical industry is paying keen attention whether Jointstem, a stem cell therapy for degenerative arthritis, will obtain regulatory approval to compete against Kolon Life Science’s Invossa.
The Ministry of Food and Drug Safety’s central pharmaceutical affairs council said it would review giving conditional approval for Jointstem as a cell therapy at its subdivision meeting for clinical evaluation and cell/gene therapies on Tuesday.
Based on the feasibility of the clinical trial design of Jointstem, the council plans to decide next Tuesday on the treatment’s efficacy in improving joint function in patients with degenerative knee osteoarthritis suffering the severity at Kellgren & Lawrence (K-L) Grade 3 or higher.
Jointstem is an autologous adipose-derived mesenchymal stem cell injection, developed by Nature Cell and R Bio.
Nature Cell said the injection treatment proved safety and efficacy in phase-2 trials on 19 patients in the U.S.
According to the company, Jointstem met the efficacy evaluation criteria without severe side effects or dropouts.
The injection showed statistically significant effectiveness in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score that measures the severity of arthritis, VAS (Visual Analog Scale) measuring pain, and cartilage improvement in MRI (magnetic resonance imaging) scans.
The higher the WOMAC score rises, the more severe the symptom becomes. Before the treatment, patients had 36.38-60.12 WOMAC. Six months after the treatment, the scores went down to 11.86-32.83. After a year, they fell further to 9.29-30.09. The patients’ joint function also improved with the scores declining from 38.8-43.91 to 11.2-22.01.
For detailed pain assessment, the study used the VAS score (Grade 0 to 10, a higher figure indicates more severe pain) in 100-point scale. The patients’ VAS scores went down to 13.17-33.30 after the treatment, compared to 57-79.58 before the treatment.
In the KOOS (Knee injury and Osteoarthritis Outcome Score) assessing patients' capability for daily activities (a higher reading indicates an improvement), the score for pain went up from 42.60-55.32 to 78.40-86.80. The score for symptoms also rose from 43.97-57.74 to 67.56-77.80, and capability for daily activities, from 41.10-65.50 to 84.20-93.74.
Kolon Life Science’s Invossa received approval in July last year, after the central pharmaceutical affairs council’s review in April and June.
Invossa is used for treating patients with K-L Grade 3 knee osteoarthritis whose symptoms continue despite conservative therapies such as medication and physical therapy for more than three months.
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