Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) for Intra-articular Delivery to Knees With Osteoarthritis

Cytori Therapeutics0 sitesSeptember 2014

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Cytori Therapeutics
Primary Endpoint: Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

July 2017

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cytori Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)

Time Frame: 90 days

Secondary Outcomes

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 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 WORMS scoring (Whole Organ MRI of the knee)(Days 180 and 365)