Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vertebral bony fusion
研究概览
简要总结
This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc
详细描述
Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone.
In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area.
Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.
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
盲法说明
Participants do not know which treatment they receives. Outcome assessor is a radiologist
入排标准
- 年龄范围
- 15 Years 至 64 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinicoradiologically diagnoses Spinal Tuberculosis
- •receives Anti TB drugs
- •minimun destruction 1/3 vertebral body
排除标准
- •patient under 15 years old
- •reject to be included in the study
研究组 & 干预措施
MSC Group
Mesenchymal Stem Cell + NaCl 0,9% 2ml
干预措施: Mesenchymal Stem cell + Nacl 0.9% (Combination Product)
MSC Group
Mesenchymal Stem Cell + NaCl 0,9% 2ml
干预措施: NaCl 0.9% (Combination Product)
结局指标
主要结局
Vertebral bony fusion
时间窗: 1 Year
trabecular bone on xray and CT scan
次要结局
未报告次要终点
研究者
Ahmad Jabir Rahyussalim
Dr. dr. Rahyussalim SpOT(K)
Indonesia University
