NCT01453738已完成2 期
A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Number and percentage of patients with adverse events as a measure of safety and tolerability
研究概览
简要总结
This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females in the age 40 - 70 years (both inclusive)
- •Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
- •History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
- •Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.
- •Patients who have been on stable medication which may be NSAIDs / Opioid or opiate analgesics, for the past three months.
- •Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •Ability to provide written informed consent.
排除标准
- •Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
- •History of surgery, or major trauma to the study joint
- •Arthroscopy on the study joint in the previous 12 months
- •Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination
- •Patients who had received intraarticular steroids or hyaluronan within the last three months.
- •Infections in or around the knee.
- •Patients awaiting a replacement knee or hip joint
- •Patients with other conditions that cause pain
- •Patients with deformity of the knee joint.
- •Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
- •Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
- •Other pathologic lesions on x-rays of knee
- •Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or RPR
- •History of Bleeding disorders
- •Known hypersensitivity to Hyaluronan products or animal sera
- •For women of child-bearing potential: positive pregnancy test or lactating [Females who are planning pregnancy within next one year should be excluded]
结局指标
主要结局
Number and percentage of patients with adverse events as a measure of safety and tolerability
时间窗: 2 years
* Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording. * Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.
次要结局
- Change from baseline in WOMAC OA composite index(2 years)
- Change from baseline in WOMAC OA stiffness index(2 years)
- Change from baseline in radiographic (X-ray) findings of knee(2 years)
- Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI(2 years)
- Change from baseline in arthritis pain scores on the visual analogue scale(2 years)
- Reduction in the intake of analgesic tablets from baseline(2 years)
- Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score(2 years)
- Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)(2 years)
研究者
研究点 (10)
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