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

Osteoarthritis Clinical Trial

— RELIEVE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02736110
• Other study ID #: RELIEVE
• Status: Withdrawn
• Phase: N/A
• First received: March 15, 2016
• Last updated: April 12, 2016
• Start date: September 2014
• Est. completion date: July 2017

Study information

• Verified date: April 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)		90 days	No
Secondary	Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)		Days 7, 30, 180 and 365	No
Secondary	Change in knee pain assessed by VAS Assessments		Days 7, 30, 90, 180 and 365	No
Secondary	Change in knee function as assessed by the Lysholm Knee Scoring Scale		Days 7, 30, 90, 180 and 365	No
Secondary	Change in WORMS scoring (Whole Organ MRI of the knee)		Days 180 and 365	No
Secondary	Change in knee function as measured by Tegner Activity Scale		Days 7, 30, 90, 180 and 365	No
Secondary	Change in knee function as measured by the Lower Extremity Functional Scale		Days 7, 30, 90, 180 and 365	No