Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Randomized Non Blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- knee pain assessed by Visual Analogue Scale.
研究概览
简要总结
Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA).
Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.
详细描述
The aim of the present study will be to compare 3 types of intra-articular injections of MSC populations obtained from two clinically relevant sources: injections containing BM-MSC or AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.
To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function and quality of life in patients with knee OA.
A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
A randomized non blind clinical trial with active control. For this purpose, the random number generator is 54, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)
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
- None
盲法说明
A randomized non blind clinical trial with active control. For this purpose, the random number generator, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 70 years, with grade II and III knee OA, according to the Ahlbäck classification will be included.
- •Minimal VAS pain score of
- •Chronic knee pain of mechanical origin.
- •All patients who sign a specially prepared informed consent for this clinical trial.
排除标准
- •Varus or valgus knee mal alignment superior to 10°.
- •OA grade IV according Ahlbäck classification.
- •Bone marrow cancer like lymphoma.
- •Severe anemia.
- •Active infections.
- •Pregnant patients.
- •Inmune diseases such as Rheumatoid arthritis, gout or pseudogout arthritis, psoriasis.
- •Bone diseases such as Kahler and Paget.
- •Corticoesteroid and hyaluronic injections within the last 3 months.
- •Knee surgery in the last 6 months.
结局指标
主要结局
knee pain assessed by Visual Analogue Scale.
时间窗: 12 months
psychometric response scale which used in questionnaires. It is a measurement instrument for subjective characteristics of pain . Score from O to 10. O indicate no pain, and 10 indicate the worst pain.
knee function assessed by WOMAC (Wester Ontario McMaster Osteoarthritis Index). quosteionary.
时间窗: 12 months
The Index contains 24 questions five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Individual question responses are assigned a score of between 0 (extreme) and 4 (None). Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Finally, raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).
次要结局
- Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix(6 months after procedure)
研究者
Dr. Carlos Chiriboga Accini
Research Professor. Orthopaedic Staff. Omnihospital.
Universidad Catolica Santiago de Guayaquil