A Phase I-IIa Safety and Efficacy Pilot Clinical Trial of Intraarticular Administration of Autologous Mesenchymal Cells for Meniscus Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VAS for pain
研究概览
简要总结
The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
详细描述
This is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (Crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by VAS of pain at 12 month. Secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (IKDC, KOOS, Lysholm and SF-36.
Patients will be randomized to one of the two treatment arms (XCEL-M-ALPHA and standard rehabilitation program or standard rehabilitation program alone). Thereafter, patients will be followed for 12 months.
Imaging assessment will be performed by an independent blinded radiologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 40 and 60 years of age
- •Degenerative meniscus injury grade 3 (Crues et al.)
- •Indication of conservative treatment
- •Normal alignment of the knee (between 3º varus and 10 º valgus)
- •Patient is able to follow a rehabilitation program
- •Informed consent given by the patient in writing
- •Patient is able to understand the trial.
排除标准
- •Traumatic meniscus injury
- •Surgical intervention to the affected knee
- •Local or systemic infection
- •Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
- •Significant abnormal laboratory tests that contraindicates participation in the trial.
- •Pregnant women or intend to become pregnant or breast-feeding
- •Neoplastic process within the previous 5 years or without complete remission.
- •The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- •Legally dependant patient.
- •The patient does not accept to be followed-up for a period that could exceed the clinical trial length
研究组 & 干预措施
XCEL-M-ALPHA and standard rehabilitation
Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program
干预措施: XCEL-M-ALPHA and standard rehabilitation (Drug)
standard rehabilitation
Standard rehabilitation program
干预措施: Rehabilitation (Other)
结局指标
主要结局
VAS for pain
时间窗: 12 month
Visual analogue scale (VAS) for pain at 12 month follow-up.
次要结局
- Efficacy by MRI(6 and 12 month)
- Efficacy by clinical questionnaires(3, 6 and 12 month)
- Safety(12 month)
- VAS for pain(1, 3 and 6 month)