2024-514545-11-00招募中3 期
Phase III, multicentre, randomized, open clinical trial comparing treatment with allogenic mesenchymal cells against autologous mesenchymal cells and against active control with hyaluronic acid in patients with knee osteoarthritis.
Fundacion Instituto De Estudios De Ciencias De La Salud De Castilla Y Leon8 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Measurement of pain intensity according to the VAS pain scale at 12 months.
研究概览
简要总结
To compare the efficacy of allogeneic mesenchymal stem cells (MSC) and autologous MSC versus an active control with hyaluronic acid in terms of clinical, functional and radiological response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Randomized, Open-label, Clinical Trial comparing 3 active treatments.
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Kellgren and Lawrence grade 2, 3 or 4 gonarthrosis.
- •Chronic painful knee with mechanical features.
- •Absence of local or systemic septic process.
- •Haemacytometric and biochemical analyses without significant alterations contraindicating treatment.
- •Written informed consent obtained from the patient.
- •The patient is able to understand the nature of the study.
- •Body Mass Index between 20 and 35 kg/m2.
排除标准
- •Patient < 18 years old, or legally dependent.
- •Patient > 75 years old.
- •Congenital or evolutive diseases that result in malformation and/or significant deformities of the knee (varus<10º; valgus<20º) and cause difficulties in the application and evaluation of the results.
- •Pregnant or breastfeeding women.
- •Neoplastic disease
- •Intra-articular infiltration of any drug within 3 months prior to inclusion in the study.
- •Concurrent participation in another clinical trial or treatment with another investigational product in the 30 days prior to inclusion in the study.
- •Allergy to gentamicin (antibiotic used in the cell culture process).
- •Other illnesses or circumstances that might compromise the patient participation in the study according to medical criteria.
结局指标
主要结局
Measurement of pain intensity according to the VAS pain scale at 12 months.
Measurement of pain intensity according to the VAS pain scale at 12 months.
Assessment of functional capacity and pain according to the Lequesne scale at 12 months
Assessment of functional capacity and pain according to the Lequesne scale at 12 months
Measurement of symptomatology and perceived physical disability according to the WOMAC scale at 12 months.
Measurement of symptomatology and perceived physical disability according to the WOMAC scale at 12 months.
Estimation of lesion improvement or stabilisation on T2-mapping MR images at 12 months.
Estimation of lesion improvement or stabilisation on T2-mapping MR images at 12 months.
次要结局
- Assessment of perceived quality of life on the SF-12 scale at 6, 12 and 24 months.
- Rate of products not complying with the validation criteria in each experimental treatment branch.
- Rate of autologous products that could not be manufactured due to alterations in the serological profile of the patients.
- Rate of medication-related adverse effects in each of the treatment arms.
- Cell product studies. In this exploratory objective, genomic studies will be performed by RNA-seq and open array on the advanced therapy drugs manufactured in the study (both autologous and allogeneic), and a correlation will be made with clinical and biological parameters and response, but they are not included in the explicit secondary variables, because they will also require subsequent validation.
- Biological studies to evaluate the immune system in the patient's blood and serum (days +7 and +30) As these are exploratory objectives, statistical analyses of correlations between the results of the biological variables and the clinical parameters will be carried out, but they are not included among the explicit secondary variables, because they will also require subsequent validation.
研究者
Esperanza Lopez Franco
Scientific
Fundacion Instituto De Estudios De Ciencias De La Salud De Castilla Y Leon
研究点 (8)
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