jRCT2013210076进行中（未招募）不适用
Treatment of lumbar canal stenosis with a combination of ultra-purified, allogenic, bone marrow-derived, mesenchymal stem cells (REC) and in situ-forming gel: a multicentre, prospective, double blind, randomised, controlled trial
未提供0 个研究点目标入组 45 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •1.Candidate for laminoplasty following lumbar discectomy for combined lumbar spinal canal stenosis (LSCS).
- •Radiographic findings corroborating symptoms of combined LSCS.
- •Condition unresponsive to six consecutive weeks of therapy or experiencing acute/uncontrolled leg pain, defined as a score >80 on the 100-mm visual analogue scale (VAS), in which higher scores represent worse pain.
- •Single-level combined LSCS.
- •Persistent and predominant leg pain (score >40 on the 100-mm VAS)
- •Age between 20 and 75 years (inclusive).
- •Willingness to provide written informed consent, fill in all necessary questionnaires, and return for follow-up.
排除标准
- •Previous surgery involving a lumbar level.
- •Prior or planned spinal fusion involving a lumbar level.
- •Local kyphosis involving the affected disc level, evident on plain radiography of the lumbar spine in the flexion, neutral or extension position.
- •Intradiscal air pattern at the affected level.
- •Spondylolisthesis or retrolisthesis above grade 1 at the affected level.
- •IVD (height obtained by averaging the anterior and posterior heights of the IVD to be operated in the lumbar X-ray image in the neutral position) less than or equal to an average half of the adjacent caudal disc height.
- •History of treatment with condoliase.
- •Severe hypersensitivity to serum albumin or antibiotics.
- •Acute local or systemic infection.
- •Active malignancy or other similar comorbidities.
- •Current drug or alcohol dependency.
- •Current significant emotional disturbance.
- •Current fracture, tumour, and/or deformity of the lumbar spine.
- •Current or planned pregnancy.
- •Currently enrolled in other research that could confound the results of the present trial.
- •Presence of a metal implant or any other contraindication to magnetic resonance imaging (MRI).
- •Allergy to sodium alginate revealed upon skin prick testing.
- •Any other reason judged by an investigator or clinical trial doctor that renders the candidate unsuitable for this clinical trial.
结局指标
主要结局
Safety
时间窗: 48 weeks after the surgical treatment
Adverse events occurring 48 weeks after the surgical treatment will be summarized with laboratory tests used as a safety assessment. Safety will be evaluated by the incidence of adverse events.
Effectiveness
The respective pain scores (VAS) for low back pain and leg pain (for both the most painful leg and the contralateral leg) and MRI imaging assessment (modified Pfirrmann classification, disc height index (DHI)) will be conducted.
次要结局
- MRI image evaluation
研究者
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