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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WJ-MSC group | Experimental | 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. |
|
| Teriparatide group | Active Comparator | subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WJ-MSC | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry |
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Inclusion Criteria:
Postmenopausal women over 40 years of age
Compression fracture of the spine confirmed by MRI or bone scan
Oswestry Disability Index (ODI) due to vertebral fracture is more than 30%
Back pain due to vertebral fracture has a Visual Analogue Scale (VAS) of 4 or higher.
In case of writing consent for stem cell transplantation therapy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA University, CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D058866 | Osteoporotic Fractures |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
|
| Teriparatide | Drug | subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months. |
|
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 |
| 12 months |
| Presence of new vertebral fracture | identification of spine fracture based on x ray | 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 | 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |