Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement of Low Back Pain
研究概览
简要总结
This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.
详细描述
The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem cell implantation therapy in intervertebral disc degeneration patients.
The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that autologous mesenchymal stem cell administration is not possible in terms of taking the source of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.
This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA and Frankel scale, as well as assessment of the widening of the lumbar region using the Schober Test), changes in the structure of the intervertebral discs (through MRI examination and grading the degree of intervertebral disc degeneration), conduction function spinal cord nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the quality of life status of patients using the Oswestry Disability Index.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
- •No history of metabolic, autoimun and genetic disease(s).
- •No active infection (HbsAg, HIV, CMV, Rubella).
- •Agree to participate the study by signing informed consent form.
排除标准
- •Patients under 20 years old.
- •Declined to participate in the study.
研究组 & 干预措施
Mesenchymal Stem Cell
Mesenchymal Stem cell + Nacl 0.9%
干预措施: Mesenchymal Stem Cell + NaCl 0,9% 2ml (Drug)
结局指标
主要结局
Improvement of Low Back Pain
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.
Tissue Improvement
时间窗: 6 months
Tissue improvement confirmed by intervertebral disc MRI
次要结局
未报告次要终点
研究者
Ahmad Jabir Rahyussalim
Dr. dr. Rahyussalim SpOT(K)
Indonesia University