Maguire Greg, Friedman Peter
Bio Regenerative Sciences, Inc. San Diego, CA 92121, USA.
Animal BioSciences, LLC Bartow, FL 33830, USA.
Future Sci OA. 2020 May 29;6(7):FSO592. doi: 10.2144/fsoa-2020-0027.
We sought to determine the safety profile of a therapeutic candidate composed of the released molecules from a combination of human adipose-derived mesenchymal stem cells and fibroblasts. Although stem cells, their progenitor cells and the molecules that are released from these cells have some demonstrated therapeutic value, much more needs to learn about the efficacy, mechanism of action and the safety profiles of these stem cell-based therapeutics.
A number of cellular, , and human studies were performed to analyze cellular, tissue and systemic safety profiles of the combinatorial product.
At the levels tested in this study, ranging from demonstrated therapeutic doses to supratherapeutic doses, the combinatorial product demonstrated an excellent safety profile in all , cellular, tissue and systemic studies.
We found evidence that a therapeutic candidate composed of the molecules released from human adipose-derived mesenchymal stem cells and human fibroblasts has an excellent safety profile, and that the product warrants further studies for safety and efficacy where dosing may include topical application, injection and oral application.
我们试图确定一种由人脂肪间充质干细胞与成纤维细胞组合释放的分子构成的治疗候选物的安全性。尽管干细胞、其祖细胞以及从这些细胞释放的分子已显示出一定的治疗价值,但对于这些基于干细胞的疗法的疗效、作用机制和安全性,仍有许多需要了解的地方。
进行了多项细胞、……以及人体研究,以分析该组合产品的细胞、组织和全身安全性。
在本研究测试的剂量水平范围内,从已证明的治疗剂量到超治疗剂量,该组合产品在所有……、细胞、组织和全身研究中均显示出优异的安全性。
我们发现证据表明,一种由人脂肪间充质干细胞和人成纤维细胞释放的分子构成的治疗候选物具有优异的安全性,并且该产品在给药方式可能包括局部应用、注射和口服的情况下,值得进一步开展安全性和有效性研究。