Registry of Celution Device for the Processing of Adipose... | NCT02736110

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

NCT02736110

Sponsor

Cytori Therapeutics

Status

Withdrawn

Last Update Posted

Apr 13, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate decision

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Apr 12, 2016

First Posted Date

Apr 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2016

Last Update Posted Date

Apr 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Steven Kesten	Cytori Therapeutics	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided