Phase I Clinical Trial To Evaluate The Intravenous Infusion Of Autologous Fucosylated Bone Marrow Mesenchymal Cells Therapy In Patients With Established Osteoporosis and Low Impact Fractures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of serious and non-serious adverse events related to the procedure.
研究概览
简要总结
The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis by a prospective, single-center, open, non-randomized and unblinded clinical trial.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with established osteoporosis according to standard clinical criteria.
- •Patients who give their written informed consent to participate in the study consent.
- •Meet all the inclusion criteria
排除标准
- •Patients with concomitant systemic disease in the opinion of the investigator.
- •Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis.
- •Current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin.
- •Patients with genetic disorders that are associated with secondary osteoporosis: Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome, Marfan syndrome, Riley Day, porphyria, storage diseases syndrome.
- •Patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation.
- •Transplant patients: bone marrow, kidney, liver, heart, lung.
- •Patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction.
- •Patients participating in a clinical trial in the last 6 months.
- •Patients with positive serology for hepatitis B, hepatitis C or HIV.
- •Patients with inability to understand informed consent.
- •Patients who are pregnant or breast-feeding actively.
- •Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
研究组 & 干预措施
Fucosylated MSC for Osteoporosis
Autologous Bone Marrow fucosylated mesenchymal stem cells will be infused intravenously on Day 0. The first four patients enrolled will receive a single dose of 2 million cells/Kg and the last six patients enrolled, will receive a single dose of 5 million cells/kg.
干预措施: Fucosylated MSC for Osteoporosis (Biological)
结局指标
主要结局
Rate of serious and non-serious adverse events related to the procedure.
时间窗: 24 months from baseline
During time frame the following items will be considered: Adverse effects related to the infusion moment. Occurrence of infectious complications after infusion of mesenchymal stem cells, because of the immunosuppressive effect of these cells. Appearance of procedure-related neoplasias.
次要结局
- Number of new fractures(24 months from baseline)
- Bone metabolism, measured by biochemical index(24 months from baseline)
- Bone formation, measured by biochemical index(24 months from baseline)
- Pain, measured by Visual Analog Scale(24 months from baseline)
- Quality of Life, measured by EuroQoL-5D test(24 months from baseline)
- Bone resorption, measured by biochemical index(24 months from baseline)
- Bone structure, measured by histomorphometric evaluation(baseline and 4 months from baseline)
- Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)(24 months from baseline)
- Trabecular bone density measured by quantitative computed tomography of the radius(24 months from baseline)
- Functionality, measured by Oswestry Disability Questionnaire(24 months from baseline)