NCT06949137

Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture

A Single-center, Open-label, Single-arm, 3+3 Dose-escalation Phase I Clinical Study to Evaluate Safety and Tolerability of HMM910(Human Mesenchymal Stem Cells Injection) in Postmenopausal Women With Osteoporosis and at High Risk of Fracture

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: HELP Therapeutics Co., Ltd. · Industry
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of human umbilical cord-derived mesenchymal stem cells for injection (HMM910 ) in postmenopausal women with osteoporosis who are at high risk of fracture.

Conditions

• Osteoporosis in Post-menopausal Women
• Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	Human Umbilical Cord-derived Mesenchymal stem cell	Intravenous infusion of human mesenchymal stem cells (HMM910 ) at 20-25 drops per minute

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-03-06
• Completion: 2026-09-06
• First posted: 2025-04-29
• Last updated: 2026-02-10

Locations

1 site across 1 country: China