[Translation] A single-center, open-label, single-arm, 3+3 dose-escalation phase I clinical study to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells (hMSC100) for injection in postmenopausal women with osteoporosis at very high risk of fracture
主要目的:
考察注射用人脐带间充质干细胞(hMSC100)在极高骨折风险的绝经后妇女骨质疏松症患者中的安全性及耐受性,为后续临床试验设计提供依据。
次要目的:
探索注射用人脐带间充质干细胞(hMSC100)在极高骨折风险的绝经后妇女骨质疏松症患者中的药代动力学特征及初步有效性。
[Translation] Main purpose:
To investigate the safety and tolerability of human umbilical cord mesenchymal stem cells (hMSC100) for injection in postmenopausal women with osteoporosis at very high risk of fracture, and to provide a basis for the design of subsequent clinical trials.
Secondary purpose:
To explore the pharmacokinetic characteristics and preliminary effectiveness of human umbilical cord mesenchymal stem cells (hMSC100) for injection in postmenopausal women with osteoporosis at very high risk of fracture.