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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males or females in the age 40 ââ?¬â?? 65 years (both inclusive)
- •2. History of primary osteoarthritis of the knee characterized by pain which requires intake of analgesics
- •3. 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
- •4. Patient on analgesic medication for OA, for 6 weeks based on Investigatorââ?¬•s feedback.
- •5. 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).
- •6. Willing to refrain from any other stem cell treatment for 2 year during the study.
- •7. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •8. Willing to provide written informed consent including audio-video consent
排除标准
- •1. 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
- •2. 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
- •3. 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 investigatorââ?¬Ë?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
- •4. History of surgery or major trauma to the study joint
- •5. Arthroscopy on the study joint in the previous 12 months
- •6. 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
- •7. Acute exacerbations of the study joint in the past 6 weeks
- •8. Patients who had received intra-articular steroids or hyaluronan within the last 3 months
- •9. Patients who had taken any stem cell treatment in the past by any route of administration
- •10. Infections in or around the study knee
- •11. Patients awaiting a replacement of knee or hip joint
- •12. Patients with other conditions that cause pain in the knee joint
- •13. Patients with gross deformity (varus by x-ray of the knee or flexion deformity > 10Ã?° by gonometer) of the knee joint based on PI judgment
- •14. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
- •15. Patients with any secondary causes of arthritis e.g. rheumatoid arthritis, systemic lupus erythematous, ulcerative colitis, psoriasis, rheumatic or inflammatory disease
- •16. Patients with BMI ââ?°Â¥30 kg/m2
- •17. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus ââ?¬â?? I & II (HIV ââ?¬â?? I & II) antibody test, TPHA or CMV (IgM)
- •18. History of Bleeding disorders
- •19. Known hypersensitivity to hyaluronan products or animal sera or constituents of IMP
- •20. Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception
研究者
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