NCT02736110

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

March 15, 2016

Last Update Submit

April 12, 2016

Conditions

Osteoarthritis

Keywords

Osteoarthritis, knee

Outcome Measures

Primary Outcomes (1)

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

    90 days

Secondary Outcomes (6)

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

    Days 7, 30, 180 and 365

  • Change in knee pain assessed by VAS Assessments

    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 function as measured by Tegner Activity Scale

    Days 7, 30, 90, 180 and 365

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that are schedule to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Steven Kesten

    Cytori Therapeutics

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 13, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

July 1, 2017

Last Updated

April 13, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share