CTRI/2018/02/011844已完成未知
se of Autologous adipose tissue derived Stromal Vascular fraction in treatment of Knee Osteoarthritis and Chondral Lesion
Sahaj Regenerative Cell Therapeutics LLP0 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
- 已完成
- 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 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 400mtrs, getting in and out of a chair or going up n downstairs.
- •3. Radiographic evidence of grade I to IV 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 treatment.
- •5. Patients who have been on stable medication for past 3 months.
- •6. Able to complete 2 week washout period during which NSAIDs are prohibited.
- •7. Patients who have not received any Intra articular steroids or hyaluronic acid within the last 3 month.
- •8. The patient is able to understand the nature of the study Informed written consent provided by the patient.
排除标准
- •1. Prior or ongoing medical condition (eg: concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigatorâ??s opinion could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up could be completed or could impair the assessment of the 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 the Osteoarthritis of the knee, a large, bulging effusion of the study knee joint with 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. Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study.
- •6. Patients with other conditions that cause pain or Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or interpretation of results.
- •7. Patients taking corticosteroid medicines or hyaluronic injection in the last 3 months.
- •8. Significant incapacitated or disabled and would be categorized as ACR functional Class IV (largely or wholly incapacitated), or unable to walk without assisted devices.
- •9. Patients with other known rheumatic or inflammatory disease such as RA, Gout, hepatitis or syphilis or Bleeding disorders.
- •10. Positive Hepatitis B surface antigen, Hepatitis C antibody test, Antihuman Immunodeficiency Virus (HIV) antibody test or VDRL.
- •11. Neoplasia & Immunosuppression.
- •12. For a woman of childbearing potential; +ve pregnancy test or breastfeeding.
- •13. Age >90 or <18 years or legally dependent.
- •14. Obesity, with body mass index >30 (calculated as a mass in kg/ height in m2).
- •15. Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or interpretation of results.
- •16. Other conditions that may, according to medical criteria, discourage participation in the study.
- •17. Active neoplastic disease in the previous 3 years
- •18. Knee deformity more than 15 Degree Varus or valgus
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