A Single-center, Open-label, Single-arm, 3+3 Dose-escalation Phase I Clinical Study to Evaluate Safety and Tolerability of hMSC100 (Human UC-MSC Injection) in Postmenopausal Women With Osteoporosis and at High Risk of Fracture
The primary objective of this study is to evaluate the safety and tolerability of human umbilical cord-derived mesenchymal stem cells for injection (hMSC100) in postmenopausal women with osteoporosis who are at high risk of fracture.
• All of the following criteria must be met for inclusion:
• Willingness to participate in the clinical trial and signing of informed consent;
• Female, age between 45 (inclusive) and 85 (inclusive) years, with primary menopause for ≥2 years;
• Body weight ≥40 kg, and body mass index (BMI) between 18 kg/m² (inclusive) and 30 kg/m² (inclusive);
• Meets the diagnostic criteria for osteoporosis, exhibiting at least one of the following:
⁃ Sustained a fragility fracture within the past 2 years;
‣ Suffered a fracture while receiving anti-osteoporosis medication;
∙ History of multiple-site fractures (including vertebral, hip, proximal humerus, or distal radius, etc.);
• Bone mineral density (BMD) T-score \< -3.0 at the lumbar spine (L1-L4) or hip (total hip or femoral neck) as measured by DXA;
⁃ High risk of falling;
‣ Calculated by FRAX (Fracture Risk Assessment Tool), a 10-year risk of major osteoporotic fracture \>30% or hip fracture risk \>4.5%;
∙ Currently using medications known to cause skeletal harm \[such as high-dose glucocorticoids (prednisolone ≥7.5 mg/day for over 3 months), etc.\].