Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.
| Condition(s) | Osteoarthritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA. |
| Who can participate | Inclusion Criteria: 1. Male or female, aged 18 to 95 years old 2. Residents of Canada 3. Written informed consent to participate in the study 4. Willingness and ability to comply with the study procedures and phone visit schedules and ability to follow verbal and written instruction 5. The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain). 6. Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening based on an X-ray performed within 1 year prior to screening period. 7. Radiographic evidence of OA of the index knee or hip (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening or during the screening period. 8. Failed conservative treatment for more than 12 wee |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Lead sponsor | Grigory Karmy |
| Locations | Brampton, Ontario, Canada |
| Start date | 2022-08-23 |
| NCT ID | NCT05507099 |
| Official listing | https://clinicaltrials.gov/study/NCT05507099 |