Use of Autologous adipose tissue derived Stromal Vascular fraction in treatment of Knee Osteoarthritis and Chondral Lesion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety, efficacy and tolerability on the basis of adverse event
研究概览
简要总结
Evaluating safety and efficacy in group of patients undergoing Autologous Stromal Vascular fraction grafting done in a single surgical sitting in treatment of knee Osteoarthritis and Chondral lesions
In which isolation of Stromal Vascular Fraction is done without using Enzymes, Chemical and Animal Products
Modified KOOS clinical score was used to evaluate clinical effect and was based on pain, non-steroid
analgesic usage, limping, extent of joint movement, and stiffness evaluation before and at pre-operative, 1 Month
post-op, 6 months post-op and 12 Months post-op after grafting. No side effects, systemic infection or cancer was
associated with Autologous grafting of SVF. There was a significant improvement from pre-op to post op in all the
followed patients. Average KOOS score improved from pre-operative 46.4 to post-operative 12 months average 77.9
i.e. very significant improvement in all grades. All sub-scale parameter for pain, symptoms, activity of living and
quality of life showed significant improvement. Higher grade of OA were associated with comparatively slower
healing.
Conclusions: Autologous grafting of SVF in single surgical sitting is a novel and promising treatment approach for
patients with degenerative OA. This treatment method was found to be minimal invasive, safe and cost-effective
treatment modality for osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •History of primary idiopathic osteoarthritis of knee characterized by pain of moderate intensity.
- •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.
- •Radiographic evidence of grade I to IV osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
- •Daily pain on activity and persistent pain despite the use of other anti-inflammatory or analgesic treatment.
- •Patients who have been on stable medication for past 3 months.
- •Able to complete 2 week washout period during which NSAIDs are prohibited.
- •Patients who have not received any Intra articular steroids or hyaluronic acid within the last 3 month.
- •The patient is able to understand the nature of the study Informed written consent provided by the patient.
排除标准
- •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 investigator’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.
- •History of surgery, including arthroscopy or major trauma to the study joint in the previous 12 months.
- •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.
- •Infections in or around the knee.
- •Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study.
- •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.
- •Patients taking corticosteroid medicines or hyaluronic injection in the last 3 months.
- •Significant incapacitated or disabled and would be categorized as ACR functional Class IV (largely or wholly incapacitated), or unable to walk without assisted devices.
- •Patients with other known rheumatic or inflammatory disease such as RA, Gout, hepatitis or syphilis or Bleeding disorders.
- •Positive Hepatitis B surface antigen, Hepatitis C antibody test, Antihuman Immunodeficiency Virus (HIV) antibody test or VDRL.
- •Neoplasia & Immunosuppression.
- •For a woman of childbearing potential; +ve pregnancy test or breastfeeding.
- •Age >90 or <18 years or legally dependent.
- •Obesity, with body mass index >30 (calculated as a mass in kg/ height in m2).
- •Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or interpretation of results.
- •Other conditions that may, according to medical criteria, discourage participation in the study.
- •Active neoplastic disease in the previous 3 years
- •Knee deformity more than 15 Degree Varus or valgus.
结局指标
主要结局
Safety, efficacy and tolerability on the basis of adverse event
时间窗: Pre operative | One week | One month | Three month
VAS score
时间窗: Pre operative | One week | One month | Three month
KOOS score
时间窗: Pre operative | One week | One month | Three month
次要结局
- Xray and / or MRI(pre operative and post operative)