Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients (Clinical Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Bone Mass Density (BMD)
研究概览
简要总结
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).
详细描述
Currently, preventive and therapeutic strategies for osteoporosis patients are based on calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have been found to reduce osteoporosis, clinical use for these drugs has been limited because of its potential to produce serious side effects, such as mandibular osteonecrosis and atypical femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male patients older than 50 yrs old.
- •Female patients older than 40 years old.
- •Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.
- •Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.
- •Patients with no history of consuming drug related osteoporosis.
- •No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.
- •Agree to participate the study by signing informed consent form.
排除标准
- •Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.
- •Patients under immunosuppressive, anticoagulant or corticosteroid treatment.
- •Paralysis patients after surgical treatment
- •Patients under 20 years old
- •Declined to participate in the study
研究组 & 干预措施
UC-Mesenchymal Stem Cell
Allogeneic Mesenchymal Stem Cell from umbilical cord
干预措施: Mesenchymal Stem Cell (Drug)
结局指标
主要结局
Bone Mass Density (BMD)
时间窗: 6 months
Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD). 1. Above Standard Deviation (SD) (-1) means normal 2. Between SD (-1) and (-2.5) is classified as osteopenia. Osteopenia is a condition when bone density is lower than the average, but not as low as osteoporosis. 3. Below SD (-2.5) is categorized as osteoporosis. The numbers are expected to be higher after MSC implantation.
Visual Analog Scale (VAS)
时间窗: 6 months
Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.
次要结局
未报告次要终点
研究者
Ahmad Jabir Rahyussalim
Orthopaedic and Traumatology Specialist, Principal Investigator
Indonesia University