Method for assessing validity of cell therapy product
Inventors
Kim, Su Jeong • NOH, Sang Eun • Lee, Jun Ho • LEE, Hyeon Youl • CHOI, Kyoung Baek • CHOI, Heon Sik
Assignees
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Publication Number
US-11614441-B2
Publication Date
2023-03-28
Expiration Date
Abstract
The present invention provides a method for evaluating effectiveness of a cell therapeutic agent. When using TGF-β and/or TSP-1 expression level(s) in: (a) a first population of transformed mammalian cells with TGF-β; and (b) a second population of untransformed mammalian cells with the same gene, respectively, as a criterion for determining effectiveness of a cell therapeutic agent, and whether or not expression thereof, it is possible to definitely determine the therapeutic efficacy of each cell therapeutic agent prior to initiation of the treatment. In addition, since use of a cell therapeutic agent without therapeutic effects is avoided, undesired procedures and side effects may not be entailed.
Core Innovation
The invention relates to evaluating effectiveness of a cell therapeutic agent by preparing paired cell populations comprising a first population of transformed mammalian cells with transforming growth factor beta (TGF-β) and a second population of untransformed mammalian cells with the same gene. The first and second populations are filled into individual vials, and the first population is inactivated and cultured.
Effectiveness is evaluated by measuring a concentration of TGF-β from the cultured first population and determining effectiveness of a cell composition comprising the first population and the second population as a therapeutic agent. If an expression level of TGF-β is 0.65 ng/10^5 cells/24 hours or more, it is determined that the cell composition is effective as a therapeutic agent.
In addition to the TGF-β-based effectiveness determination, the method determines an expression level of thrombospondin 1 (TSP-1) in the second population of untransformed mammalian cells.
Claims Coverage
The independent claim recites a method with five inventive features, including paired transformed/untransformed mammalian cell populations, vial-based processing with inactivation of the transformed population, culturing, measuring TGF-β concentration, a quantitative TGF-β threshold to determine therapeutic effectiveness, and determining TSP-1 expression in the untransformed population.
Paired transformed and untransformed mammalian cell populations with the same gene
Preparing (a) a first population of transformed mammalian cells with a transforming growth factor beta (TGF-β) and (b) a second population of untransformed mammalian cells with the same gene, respectively.
Vial filling and inactivation of the transformed population
Filling the first and second populations into individual vials and inactivating the first population.
Culturing and measuring TGF-β concentration to evaluate effectiveness
Culturing the first population and measuring a concentration of TGF-β from the first population.
Quantitative TGF-β effectiveness determination
Evaluating effectiveness of a cell composition comprising the first population and the second population as a therapeutic agent based on the TGF-β concentration, wherein if an expression level of TGF-β is 0.65 ng/10^5 cells/24 hours or more, it is determined that the cell composition is effective as a therapeutic agent.
Determining TSP-1 expression in the untransformed population
Determining an expression level of thrombospondin 1 (TSP-1) in the second population.
Overall, the claim coverage focuses on a paired transformed/untransformed population approach where therapeutic effectiveness is determined using a quantitative TGF-β threshold from the cultured, inactivated transformed population, combined with determination of TSP-1 expression in the matched untransformed population.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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