Efficacy of Wharton's Jelly-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- improvement in Visual Analogue Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 and method of this clinical trial as a study subject for drug or alcohol addiction
- •Those who participated in other clinical trials within 30 days prior to participation in the clinical trial
- •Those who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, blood coagulation disease, cirrhosis, kidney failure, tumor) or immune deficiency
- •Factors less than 10 g/dL of hemoglobin in general blood test
- •If there is currently an acute systemic or local infection
- •Others who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial
- •Those who are allergic to proteins required for cell production (fetal calf serum)
研究组 & 干预措施
WJ-MSC group
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.
干预措施: WJ-MSC (Drug)
WJ-MSC group
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.
干预措施: Teriparatide (Drug)
Teriparatide group
subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
干预措施: Teriparatide (Drug)
结局指标
主要结局
improvement in Visual Analogue Scale
时间窗: 12 months
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.
次要结局
- improvement in Oswestry Disability Index(12 months)
- Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry(12 months)
- Presence of new vertebral fracture(12 months)
- Change in the bone mineral density (computed tomography) of fractured vertebrae(12 months)
研究者
Inbo Han
Principal Investigator, Professor of Spine neurosurgeon, MD, PhD
CHA University