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

NCT ID: NCT02736110

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-07-31

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.

Conditions

Osteoarthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytori Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Kesten

Role: STUDY_CHAIR

Cytori Therapeutics

Other Identifiers

RELIEVE

Identifier Type: -

Identifier Source: org_study_id