Introduction
We actively develop cell therapies for various indications, aiming to provide more treatment options for patients worldwide and satisfy the unmet medical needs.
GXCPC1®, used for the treatment of knee osteoarthritis (OA), has shown that it is capable of regenerating cartilage tissue in pharmacological studies. In preclinical study, histological analysis of GXCPC1® treating mice with OA-induced model revealed newly formed cartilage tissue; toxicological safety tests showed no tumor formation.
The Phase I/II clinical trial results of GXCPC1® demonstrated that subjects in the high-dose group (4 X 10^7 hADSCs) showed significant improvement in WOMAC total score, including the pain, stiffness, and physical function subscales, visual analog scale (VAS) for pain, and the SF-12 quality of life assessment. Furthermore, no suspected unexpected serious adverse reactions (SUSARs) related to GXCPC1® were observed during the follow-up period, indicating the therapeutic potential of GXCPC1® for the treatment of OA.
Features / strengths
．Allogeneic stem cell therapy
．No waiting time required (off-the-shelf)
．Cell source supported by U.S. FDA DMF compliance
．The outcomes of clinical trial data have been published (Cell Transplant. 2024 Jan-Dec;33:9636897231221882. doi: 10.1177/09636897231221882.)
Specification in detail
Material
Adipose-derived stem cells (ADSCs)
Indication
Knee osteoarthritis (OA)
Administration
Intra-articular injection
Supporting document
