drugset / Trial / NCT05018637

Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture

NCT05018637

Phase 2 Unknown 30 enrolled Inbo Han
RandomizedParallel-groupOpen-labelTreatment

Summary

Osteoporotic vertebral compression fractures (OVCFs) are serious health problems. Transplantation of mesenchymal stem cells (MSCs) has gained considerable attention to treat osteoporosis and OVCFs because implanted healthy MSCs could be differentiated into osteoblasts and reduce the susceptibility of fractures by facilitating new bone formation. This study compares teriparatide (PTH 1-34) injection to combined treatment with Wharton's jelly-derived MSCs (WJ-MSCs) and teriparatide (PTH 1-34) in patients with OVCFs. It is a randomized, open-label, phase 2 study.

Timeline

Start
2020-09-01
Primary completion
2022-12-31
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject WJ-MSC Cell therapy 4e+07 cells Other
Background Teriparatide Protein / enzyme biologic 20 ug Subcutaneous