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临床试验/NCT04493918
NCT04493918Unknown2 期

Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)

Ahmad Jabir Rahyussalim1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月21日最近更新:
适应症
干预措施

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

Experimental

Mesenchymal Stem Cell + NaCl 0,9% 2ml

干预措施: Mesenchymal Stem cell + Nacl 0.9% (Combination Product)

MSC Group

Experimental

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

发起方
Ahmad Jabir Rahyussalim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmad Jabir Rahyussalim

Dr. dr. Rahyussalim SpOT(K)

Indonesia University

研究点 (1)

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