Development of an allogeneic stem cell product 'ELIXCYTE' for the treatment of osteoarthritis and chronic kidney disease

Autor: J. Tsai, C.C. Tsai
Rok vydání: 2020
Předmět:
Zdroj: Cytotherapy. 22:S110
ISSN: 1465-3249
DOI: 10.1016/j.jcyt.2020.03.198
Popis: Background & Aim ELIXCYTE is an allogeneic adipose stem cell product and is currently undergoing two human clinical trials. In the clinical trial of ELIXCYTE for osteoarthritis (NCT02784964), the patient enrollment of phase-I/IIa have been completed and the results of a 24-weeks follow-up have been analyzed. For chronic kidney disease (CKD) treatment (NCT02933827), the phase-II clinical trial is ongoing. In addition of clinical trial development, we established suitable mechanism of actions (MOAs) platforms to describe the pharmacology and the potency factors of ELIXCYTE. And in the process development of cell manufacturing technology, we have also made great breakthrough of mass and automatic production of ELIXCYTE by 3D bioreactor systems. Methods, Results & Conclusion Based on the pharmacological mechanisms of ELIXCYTE obtained from our pre-clinical studies, for osteoarthritis treatment, our stem cell products show good immune regulation, anti-inflammatory properties, as well as the characteristics of promoting chondrocyte proliferation and protecting chondrocytes. For CKD treatment, we proposed that ELIXCYTE can achieve the effect of maintain and repair renal function through its ability to regulate inflammation, angiogenesis, anti-fibrosis, and antioxidation. The results of clinical trials show that ELIXCYTE has good safety in the treatment of arthritis and kidney disease, and both show the potential and trends for positive response and efficacy. For osteoarthritis treatment, the trend of pain relief was shown in current data. For CKD treatment, current data show positive response of renal function index (eGFR) in CKD patients. In the breakthrough of cell manufacturing technologies, we have successfully developed the use of bioreactors for cell production in 50-L scale and the whole semi-automatic manufacturing processes have been established.
Databáze: OpenAIRE
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