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Stem Cell Therapy
Organoid
CDMO Business
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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
FURESTEM-OA Kit Inj. News of completion of Phase 1 clinical trials
23
2024.02
Kangstem Biotech today completed the dosing of six patients in the high-dose arm of its Phase 1 clinical trial of FURESTEM-OA Kit Inj. for osteoarthritis.
Kangstem Biotech today completed the dosing of six patients in the high-dose arm of its Phase 1 clinical trial of FURESTEM-OA Kit Inj. for osteoarthritis. This completes the full dosing of the Phase 1 clinical trial of FURESTEM-OA Kit, which aims to treat osteoarthritis through joint injections without knee surgery.
The Phase 1 study is divided into three groups based on stem cell dose: low, medium and high dose to evaluate the safety and tolerability of FURESTEM-OA Kit and to determine the recommended dose.
The low-dose group completed treatment at the end of August last year and is undergoing evaluation, including MRI, at six months post-treatment, and is expected to complete imaging evaluation by the end of this month. In addition, we plan to analyze the results by linking the level of change and validity of seven biomarkers related to cartilage production with the imaging evaluation.
In the mid-dose group, the dosing was completed in October, and patients were observed through pain assessment measures such as VAS, KOOS, IKDC, and daily life, and it was confirmed that osteoarthritis symptoms such as pain and knee function and activity improved by more than 60~70% compared to pre-dosing. This is an excellent improvement rate that has not been seen in any other drug developed to date, and is expected to lead to structural improvement of the knee joint.
Yo-han Bae, Head of Clinical Development at Kangstem Biotech said, "The speed and magnitude of improvement in the low- and mid-dose groups was faster and more dramatic than our initial expectations, confirming the safety and significant exploratory efficacy of FURESTEM-OA Kit in patients with moderate knee osteoarthritis," and "In particular, we are very excited about the development of the new drug, as some of the participants in the mid-dose group had suffered from osteoarthritis for a long time and showed significant improvements in activity with a single injection. Although it is only in Phase I, we will increase the business value of new drug development by securing high therapeutic effectiveness and MRI and biomarkers that can prove it."