CTRI/2011/07/001891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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
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 - 70 years (both inclusive)
- •2.Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
- •3.History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
- •4.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.
- •5.Patients who have been on stable medication which may be NSAIDs / Opioid or opiate analgesics, for the past three months.
- •6.Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •7.Ability to provide written informed consent.
排除标准
- •1.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.
- •2.History of surgery, or major trauma to the study joint
- •3.Arthroscopy on the study joint in the previous 12 months
- •4.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
- •5.Patients who had received intraarticular steroids or hyaluronan within the last three months.
- •6.Infections in or around the knee.
- •7.Patients awaiting a replacement knee or hip joint
- •8.Patients with other conditions that cause pain
- •9.Patients with deformity of the knee joint.
- •10.Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
- •11.Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
- •12.Other pathologic lesions on x-rays of knee
- •13.Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL
- •14.History of Bleeding disorders
- •15.Known hypersensitivity to Hyaluronan products or animal sera
- •16.For women of child-bearing potential: positive pregnancy test or lactating
研究者
相似试验
已完成
3 期
A reserach study to evaluate safety and efficacy of prucalopride tablet in patient having long term complain of constipatioCTRI/2015/08/006090Torrent Pharamceutical Ltd200
已完成
3 期
A clinical trial to evaluate the effects of stem cells in patients with Osteoarthritis of the Knee jointCTRI/2018/09/015785Stempeutics Research Pvt Ltd
尚未招募
4 期
A multicentric, randomised, placebo controlled double blind study to compare safety and tolerability of Saccharomyces boulardii in acute diarrhoeaCTRI/2018/06/014480Alkem Laboratories Limited
已完成
3 期
Bromhexine hydrochloride for prophylaxis against COVID-19IRCT20120703010178N22Shahid Beheshti University of Medical Sciences1,050
已完成
3 期
A Clinical Trial to Evaluate the Efficacy and Safety of Plecanatide in Subjects with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation.CTRI/2022/03/040704MSN Laboratories Private Limited210