Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis
Withdrawn
- Conditions
- Osteoarthritis
- Registration Number
- NCT02736110
- Lead Sponsor
- Cytori Therapeutics
- Brief Summary
This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Males or females > 18 years of age
- Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes
- Pain with or without swelling in the affected area for >4 months
Exclusion Criteria
- Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb
- History of documented nerve damage in the affected limb
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) 90 days
- Secondary Outcome Measures
Name Time Method Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS) Days 7, 30, 180 and 365 Change in knee function as assessed by the Lysholm Knee Scoring Scale Days 7, 30, 90, 180 and 365 Change in knee function as measured by Tegner Activity Scale Days 7, 30, 90, 180 and 365 Change in knee pain assessed by VAS Assessments Days 7, 30, 90, 180 and 365 Change in knee function as measured by the Lower Extremity Functional Scale Days 7, 30, 90, 180 and 365 Change in WORMS scoring (Whole Organ MRI of the knee) Days 180 and 365