Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat Osteoarthritis

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02736110

Acronym

RELIEVE

Enrollment

Registered

2016-04-13

Start date

2014-09-30

Completion date

2017-07-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, knee

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)	90 days

Secondary

Measure	Time frame
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 measured by Tegner Activity Scale	Days 7, 30, 90, 180 and 365
Change in knee function as assessed by the Lysholm Knee Scoring Scale	Days 7, 30, 90, 180 and 365
Change in WORMS scoring (Whole Organ MRI of the knee)	Days 180 and 365
Change in knee pain assessed by VAS Assessments	Days 7, 30, 90, 180 and 365

Outcome results