Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma(PRGF)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS)
研究概览
简要总结
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7 days.
- Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stems cells. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
- Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
- Radiographic (baseline and 12 months from treatment): Femorotibial space.
- Radiographic using MRI (baseline and 12 months from treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
详细描述
Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) with platelet richa plasma (PRGF®) in patients with knee osteoarthritis.
Patients and methods
Clinical trial phase I- II, randomized , multicenter , with two treatment arms and 19 patients for each group. The investigators compare the intraarticular injection of against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
- Group A: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days.
- Group B: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days and one with Mesenchimal stem cell. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection of platelet richa plasma (PRGF®). The treatment is completed with 2 more injection of platelet richa plasma (PRGF®) separeted by one week.
The autologous mesenchymal stem cells are obtained from the iliac crest under local anesthesia and sedation. They are cultured ex vivo The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 40 and 80 year old
- •Bad results with previous hyaluronic acid injection
- •Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology)
- •Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS)
- •Radiological Classification: Kellgren-Lawrence scale greater or equal to 2
- •Body mass index between 20 and 35 kg/m2
- •Ability to follow during the study period
排除标准
- •Bilateral Osteoarthritis of the Knee requiring treatment in both knees
- •Previous diagnosis of polyarticular disease
- •Severe mechanical deformation
- •Arthroscopy during the previous 6 months
- •Intraarticular infiltration of hyaluronic acid in the last 6 months
- •Systemic autoimmune rheumatic disease
- •Poorly controlled diabetes mellitus
- •Blood dyscrasias
- •Immunosuppressive or anticoagulant treatments
- •Treatment with corticosteroids in the 3 months prior to inclusion in the study
- •NSAID therapy within 15 days prior to inclusion in the study
- •Patients with a history of allergy to penicillin or streptomycin
研究组 & 干预措施
Platelet Rich Plasma (PRGF)
Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days.
干预措施: Platelet Rich plasma (PRGF) (Biological)
BMMSC with Platelet Rich Plasma (PRGF)
Single intraarticular injection of 100 million Bone marrow mesenchimal stem cells and three intraarticular injections of plateler Rich Plasma (PRGF) separatede by 7 days.
干预措施: 100 million Bone marrow mesenchimal stem cells (Biological)
BMMSC with Platelet Rich Plasma (PRGF)
Single intraarticular injection of 100 million Bone marrow mesenchimal stem cells and three intraarticular injections of plateler Rich Plasma (PRGF) separatede by 7 days.
干预措施: Platelet Rich plasma (PRGF) (Biological)
结局指标
主要结局
Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS)
时间窗: Day 1
Baseline Visual analogue scale (VAS) prior to the initial dose on day 1
Baseline euroquol 5D value
时间窗: Day 1
Pretreatment euroquol 5D value
Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
时间窗: Day 1
Universities Osteoarthritis Index score (WOMAC).
Visual analogue scale (VAS) at 3 months
时间窗: 3 months
Visual analogue scale (VAS) at 3 months
Baseline value of knee injury and osteoarthritis outcome score (Koos).
时间窗: Day 1
Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).
Baseline femorotibial distance
时间窗: Day 1
Prior to the intervention femoritibial distance on rosenberg x-ray view
Visual analogue scale (VAS) at 1 month
时间窗: 1 month
Visual analogue scale (VAS) at on month
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
时间窗: 3 Months
Value of knee injury and osteoarthritis outcome score (Koos) at 3 month
Baseline SF-36 value
时间窗: Day 1
Baseline SF-36 value
Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events
时间窗: Follow up (up to 12 months)
Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events During the follow up
Visual analogue scale (VAS) at 6 months
时间窗: 6 months
Visual analogue scale (VAS) at 6 months
Baseline Lequesne index
时间窗: Day 1
Prior to the intervention on day 1 Lequesne index
Visual analogue scale (VAS) at 12 months
时间窗: 12 months
Visual analogue scale (VAS) at 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
时间窗: 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 12 months
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
时间窗: 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 1 month
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
时间窗: 6 months
Value of knee injury and osteoarthritis outcome score (Koos) at 6 month
次要结局
未报告次要终点