Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebr… (NCT05018637) | Clinical Trial Compass
UnknownPhase 2
Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
South Korea30 participantsStarted 2020-09-01
Plain-language 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.
Who can participate
Age range40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal women over 40 years of age
* Compression fracture of the spine confirmed by MRI or bone scan
* When the T score of the lumbar spine is less than -1.0 in the bone density test using DXA (Dual energy X ray absorptiometry)
* Compression fracture is between 5th thoracic and 5th lumbar vertebra
* When a new vertebral fracture occurs in less than 3 parts of the spine
* Compression fracture of the spine within 6 weeks after minor trauma
* 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:
* Those who used osteoporosis treatment (bisphosphonate, selective estrogen receptor modulator, or parathyroid hormone) 6 months before the start of the clinical trial due to osteoporotic vertebral fracture.
* In the case of inherited, metabolic, neoplastic, or infectious bone disease other than osteoporosis
* Spinal fracture with neurological symptoms
* Those who are taking drugs that affect bone metabolism such as steroids.
* Those who have undergone spinal fixation surgery on the fracture site prior to the clinical trial
* Those who have a history of psychiatry or who are currently undergoing treatment, who have judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
* Those who do not understand the purpose …