CTRI/2018/09/015785已完成3 期
A Randomized, Double blind, Multicentric, Placebo controlled, Phase III study assessing the efficacy and safety of Intra-articular administration of Stempeucel®(Adult Human Bone Marrow derived, cultured, pooled, allogenic Mesenchymal stromal cells)in patients with Osteoarthritis of Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 16
- 主要终点
- To assess the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm
研究概览
简要总结
This study is randomized, double blind, multi-centric, placebo controlled, single dose phase 3 study to evaluate the efficacy and safety of bone marrow derived allogeneic mesenchymal stromal cells in patients with osteoarthritis of knee joint
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females in the age 40 – 65 years (both inclusive)
- •History of primary 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 meters, getting in and out of a chair, getting up from squatting or cross leg position or going up and down stairs
- •Patient on analgesic medication for OA, for 6 weeks based on Investigator’s feedback.
- •Radiological criteria X-ray knee joint showing radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria (based on site radiologist report).
- •Willing to refrain from any other stem cell treatment for 2 year during the study.
- •Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •Willing to provide written informed consent including audio-video consent.
排除标准
- •X-ray (evaluated by central radiologist) showing any of the following: a. Grade 0, 1 and 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria b. Subchondral sclerosis
- •MRI knee (evaluated by central radiologist) showing any of the following: a. ACL/ PCL tears b. Meniscal tears: Grade 3 tears.
- •defined as increased signal intensity on PD sequences extending up to either articular surface. It also includes root tear but excludes RAMP tear c. Patients with exclusive patello-femoral arthritis d. Grade 0, 1 and 4 arthritis as per the proposed grading on MRI
- •Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition), alcoholism, smoking, tobacco chewing or 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
- •Acute exacerbations of the study joint in the past 6 weeks
- •Patients who had received intra-articular steroids or hyaluronan within the last 3 months
- •Patients who had taken any stem cell treatment in the past by any route of administration
- •Infections in or around the study knee
- •Patients awaiting a replacement of knee or hip joint
- •Patients with other conditions that cause pain in the knee joint
- •Patients with gross deformity (varus by x-ray of the knee or flexion deformity > 10° by gonometer) of the knee joint based on PI judgment
- •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 any secondary causes of arthritis e.g. rheumatoid arthritis, systemic lupus erythematous, ulcerative colitis, psoriasis, rheumatic or inflammatory disease
- •Patients with BMI ≥30 kg/m2
- •Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus – I & II (HIV – I & II) antibody test, TPHA or CMV (IgM)
- •History of Bleeding disorders
- •Known hypersensitivity to hyaluronan products or animal sera or constituents of IMP
- •Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception.
结局指标
主要结局
To assess the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm
时间窗: 1 year
次要结局
- To assess the change from baseline to two year in WOMAC(To assess the change from baseline to one year and two years follow-up as compared to the placebo arm in)
研究者
研究点 (16)
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