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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Other: subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months. Other: intramedullary injection of 4 x 107 WJ-MSCs (direct injection into the recently fractured vertebra) at baseline (day 0). subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
CHA University, CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
improvement in Visual Analogue Scale
Change in the VAS at 1, 3, 6, 9, and 12 months after the transplantation of Wharton's jelly-derived MSCs (WJ-MSCs), compared to before the transplantation. on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine.
Time frame: 12 months
improvement in Oswestry Disability Index
Change in the ODI at 1, 3, 6, 9, and 12 months after the transplantation of WJ-MSCs, compared to before the transplantation. on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability
Time frame: 12 months
Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry
Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry at 6 and 12 months after the transplantation compared to before the transplantation
Time frame: 12 months
Presence of new vertebral fracture
identification of spine fracture based on x ray
Time frame: 12 months
Change in the bone mineral density (computed tomography) of fractured vertebrae
Change in the bone mineral density (computed tomography) at 6 and 12 months after the transplantation compared to before the transplantation
Time frame: 12 months
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