Health Condition 1: null- Patients suffering from Knee/Joint pain due to Osteoarthritis
Conditions
Interventions
Intervention1: Grafting of Stromal Vascular Fraction in knee joint: Autologous Adipose derived Stromal Vascular Fraction grafting done in a single surgical sitting for Osteoarthritis of knee
Sponsors
Sahaj Regenerative Cell Therapeutics LLP
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, efficacy and tolerability on the basis of adverse event KOOS score VAS scoreTimepoint: Pre operative One week One month Three month | — |
Secondary
| Measure | Time frame |
|---|---|
| Xray and / or MRITimepoint: pre operative and post operative | — |
Countries
India
Contacts
Public ContactDr Pankaj Mehtp
Sahaj Hospital
Outcome results
None listed