CTRI/2010/091/000270招募中未知
A Pilot Study on the Use of Allogenic Mesenchymal Stem Cells For Osteoarthritis
ADVANCED NEUROSCIENCE ALLIES PRIVATE LIMITED0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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)History of primary idiopathic osteoarthritis of the knee characterized by pain of moderate intensity.
- •2)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, or going up and down stairs.
- •3)Radiographic evidence of grade 1 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
- •4)Daily pain on activity and persistent pain despite the use of other anti-inflammatory or analgesic treatments.
- •5)Patients who have been on stable medication for the past three months.
- •6)Able to complete a 2-week washout period during which NSAIDs are prohibited.
- •7)Patients who have not received intra-articular steroids or hyaluronan within the last 3 months.
- •8)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, including arthroscopy, or major trauma to the study joint in the previous 12 months
- •3)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 after the washout period
- •4)Infections in or around the knee.
- •5)Patients awaiting a replacement knee or hip joint
- •6)Patients with other conditions that cause pain
- •7)Patients taking corticosteroid medication or Hyaluronan injection within last 3 months.
- •8)Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
- •9)Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
- •10)Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL
- •11)Bleeding disorders
- •12)Known hypersensitivity to Hyaluronan products or animal sera
- •13)For women of child-bearing potential: positive pregnancy test or lack of contraceptive use
研究者
相似试验
招募中
不适用
An open label, non randomized, uncontrolled, bio interventional, single centric, pilot study in Traumatic Brain InjuryCTRI/2010/091/000436ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)15
Unknown
1 期
Allogenic mesenchymal stem cells in patients with Dilated CardiomyopathyCTRI/2009/091/000437Stempeutics Research Pvt Ltd20
Unknown
1 期
A controlled study with allogenic mesenchymal stem cells in patients with OsteoarthritisCTRI/2009/091/000435Stempeutics Research Pvt Ltd30
Unknown
1 期
A study with allogenic mesenchymal stem cells in patients with Chronic Obstructive Pulmonary Disease (COPD)CTRI/2009/091/000436Stempeutics Research Pvt Ltd30
Unknown
1 期
A controlled study with allogenic mesenchymal stem cells in patients with Liver CirrhosisCTRI/2009/091/000432Stempeutics Research Pvt Ltd