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Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma (CMM-PRGF/ART)

2017年10月23日 更新者：Clinica Universidad de Navarra, Universidad de Navarra

Phase I/II. Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma(PRGF)

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:

  1. Group A: 3 intra-articular injections of platelet rich plasma (PRGF®) separated by 7 days.
  2. 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.

研究概览

地位

未知

条件

干预/治疗

详细说明

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:

  1. Group A: 3 intra-articular injections of platelet richa plasma (PRGF®) separated by 7 days.
  2. 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.

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, 6 and 12 months since treatment): Femorotibial space.
  • Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.

All patients met the following inclusion and exclusion criteria:

研究类型

介入性

注册 (预期的)

38

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
    • Castilla-León
      • Salamanca、Castilla-León、西班牙、37007
        • Hospital Universitario De Salamanca
    • Navarra
      • Pamplona、Navarra、西班牙、31008
        • Departamento Cirugía Ortopédica y Traumatología. Clinica Universidad de Navarra

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Platelet Rich Plasma (PRGF)
Platelet Rich plasma (PRGF) 3 intraarticular onjections sepataded by 7 days.
生物：Platelet Rich plasma (PRGF)
3 injections of PRGF
有源比较器：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.
生物：Platelet Rich plasma (PRGF)
3 injections of PRGF
生物：100 million Bone marrow mesenchimal stem cells
100 million Bone marrow mesenchimal stem cells with PRGF

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
3 个月时的视觉模拟量表 (VAS)
大体时间：3个月
3 个月时的视觉模拟量表 (VAS)
3个月
6 个月时的视觉模拟量表 (VAS)
大体时间：6个月
6 个月时的视觉模拟量表 (VAS)
6个月
12 个月时的视觉模拟量表 (VAS)
大体时间：12个月
12 个月时的视觉模拟量表 (VAS)
12个月
1 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
大体时间：1个月
1 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
1个月
3 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
大体时间：3个月
3 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
3个月
6 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
大体时间：6个月
6 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
6个月
12 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
大体时间：12个月
12 个月时膝关节损伤和骨关节炎结果评分 (Koos) 的值
12个月
Baseline Visual analogue scale (VAS) Baseline Visual analogue scale (VAS)
大体时间：Day 1
Baseline Visual analogue scale (VAS) prior to the initial dose on day 1
Day 1
Baseline value of knee injury and osteoarthritis outcome score (Koos).
大体时间：Day 1
Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).
Day 1
Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).
大体时间：Day 1
Universities Osteoarthritis Index score (WOMAC).
Day 1
Baseline SF-36 value
大体时间：Day 1
Baseline SF-36 value
Day 1
Baseline euroquol 5D value
大体时间：Day 1
Pretreatment euroquol 5D value
Day 1
Baseline Lequesne index
大体时间：Day 1
Prior to the intervention on day 1 Lequesne index
Day 1
Baseline femorotibial distance
大体时间：Day 1
Prior to the intervention femoritibial distance on rosenberg x-ray view
Day 1
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
大体时间：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
Follow up (up to 12 months)
Visual analogue scale (VAS) at 1 month
大体时间：1 month
Visual analogue scale (VAS) at on month
1 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Clinica Universidad de Navarra, Universidad de Navarra

调查人员

  • 首席研究员：José Lamo-Espinosa, MD、Clinica Universidad de Navarra
  • 研究主任：Felipe Prosper, MD, PhD、Clinica Universidad de Navarra
  • 首席研究员：Juan Blanco, MD; PhD、Complejo Universitario de Salamanca

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年6月1日

初级完成 (预期的)

2018年6月1日

研究完成 (预期的)

2018年6月1日

研究注册日期

首次提交

2014年7月18日

首先提交符合 QC 标准的

2015年2月17日

首次发布 (估计)

2015年2月18日

研究记录更新

最后更新发布 (实际的)

2017年10月24日

上次提交的符合 QC 标准的更新

2017年10月23日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CMM-PRGF/ART
  • 2011-006036-23 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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