Osteoarthritis. Other specified arthrosis
Conditions
Interventions
Intervention 1: Intervention group: Group A – SVF: Preparation: Subcutaneous abdominal fat harvested using tumescent liposuction Processed according to IFATS and ISCT guidelines Sequential filtration
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age 35–75 years Either sex Radiographic knee OA grade II–III by Kellgren–Lawrence Inadequate response to non-steroidal anti-inflammatory drugs MRI confirmation of partial or full-thickness cartilage damage in the target knee Informed consent
Exclusion criteria
Exclusion criteria: Any intra-articular injection (hyaluronic acid or corticosteroid) in the target knee within the prior 3 months Inability to undergo MRI Active or suspected infection in the target knee Positive serology for HIV, HBV, HCV, or syphilis Pregnancy or breastfeeding History of malignancy, autoimmune disease, or any uncontrolled disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety:Monitoring the absence of short-term and long-term adverse events (local or systemic). Timepoint: up to 3 months after injection. Method of measurement: according to CTCAE v5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: baseline, week 1, month 1, and month 3. Method of measurement: pain intensity measured by VAS (Visual Analog Scale).;Physical Function. Timepoint: baseline, week 1, month 1, and month 3. Method of measurement: Evaluated by WOMAC index (Western Ontario and McMaster Universities.;MRI. Timepoint: baseline and month 3. Method of measurement: Changes in WORMS (Whole-Organ MRI Score). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Bajouri
Skin and Stem Cell Research Center
Outcome results
None listed