Abstract
BackgroundMesenchymal stem cells (MSCs) have generated a great amount of interest in recent years as a novel therapeutic application for improving the quality of pet life and helping them free from painful conditions and diseases. It has now become critical to address the challenges related to the safety and efficacy of MSCs expanded in vitro. In this study, we establish a standardized process for manufacture of canine adipose-derived MSCs (AD-MSCs), including tissue sourcing, cell isolation and culture, cryopreservation, thawing and expansion, quality control and testing, and evaluate the safety and efficacy of those cells for clinical applications.ResultsAfter expansion, the viability of AD-MSCs manufactured under our standardized process was above 90 %. Expression of surface markers and differentiation potential was consistent with ISCT standards. Sterility, mycoplasma, and endotoxin tests were consistently negative. AD-MSCs presented normal karyotype, and did not form in vivo tumors. No adverse events were noted in the case treated with intravenously AD-MSCs.ConclusionsHerein we demonstrated the establishment of a feasible bioprocess for manufacturing and banking canine AD-MSCs for veterinary clinical use.
Highlights
Mesenchymal stem cells (MSCs) have generated a great amount of interest in recent years as a novel therapeutic application for improving the quality of pet life and helping them free from painful conditions and diseases
It has been reported that MSCs could be isolated from various tissues other than bone marrow [10], such as adipose [11], umbilical cord [12], dental pulp [13]
The establishment of canine Adiposederived Mesenchymal stem cells (AD-MSCs) bank operating in accordance with good manufacturing practice standards will accelerates the clinical application of canine stem cell therapy and the development of stem cell industrialization in pet market
Summary
Mesenchymal stem cells (MSCs) have generated a great amount of interest in recent years as a novel therapeutic application for improving the quality of pet life and helping them free from painful conditions and diseases. We establish a standardized process for manufacture of canine adipose-derived MSCs (ADMSCs), including tissue sourcing, cell isolation and culture, cryopreservation, thawing and expansion, quality control and testing, and evaluate the safety and efficacy of those cells for clinical applications. It has been reported that MSCs could be isolated from various tissues other than bone marrow [10], such as adipose [11], umbilical cord [12], dental pulp [13], As one of the most common companion animals, some breeds of canine including beagles are experimental animals. Many related reports have confirmed that AD-MSCs therapy in
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