2024-514475-17-00招募中2 期
Intervertebral Disc Regeneration by Autologous Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Treatment success, pain reduction compared to control group Timeframe 2 yr, no post-intervention on treated level. No unexpected events by procedure.
研究概览
简要总结
To monitor patient’s response and potential side effects of AD-MSC therapy in patients suffering from DDD compared to control group.
研究设计
- 分配方式
- Randomized
- 主要目的
- Prospective Randomized Double Blinded
- 盲法
- Double (Monitor, Investigator, Carer, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with lumbar back pain (max 2 levels)
- •age 20 to 60 yrs,
- •moderate disc degeneration (Pfirman grade 2-3)
排除标准
- •Patients with lumbar back pain of other apparent reason such as: severe spinal stenosis, herniated disc, spondylolisthesis grade 2 or more.
- •Penicillin allergies.
- •Age <20yrs, >60 yrs.
- •Cognitive impairment.
- •Treatment with cytostatic drugs.
- •High risk of bleeding (bleeding disorder, taking anticoagulants etc.).
- •Previous injections in disc.
- •Pregnancy or breastfeeding.
- •Conditions not compatible with MRI (non-compatible implants, claustrophobia, severe obesity).
- •Tumors, infection or fracture in spine.
结局指标
主要结局
Treatment success, pain reduction compared to control group Timeframe 2 yr, no post-intervention on treated level. No unexpected events by procedure.
Treatment success, pain reduction compared to control group Timeframe 2 yr, no post-intervention on treated level. No unexpected events by procedure.
VAS-score
VAS-score
pain diary
pain diary
EQ-5D
EQ-5D
ODI
ODI
SF-36
SF-36
LBPRS
LBPRS
次要结局
- MR morphology of disc: height, water content, fat and lipid, lactose, glucose, proteoglycans, collagen.
研究者
Michael Pedersen
Scientific
Aarhus Universitet
研究点 (1)
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