Use of Cell Therapy to Enhance Arthroscopic Knee Cartilag... | NCT01799876

Studies
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

NCT01799876

Sponsor

Fondren Orthopedic Group L.L.P.

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Articular Cartilage Defect Grade III or IV of the Knee

Interventions

Autologous Cell
Standard microfracture arthroscopic surgery

Countries

United States

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2017Actual

First Submitted Date

Feb 22, 2013

First Submission Date that Met QC Criteria

Feb 26, 2013

First Posted Date

Feb 27, 2013Estimated

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

Jan 9, 2019

Last Update Posted Date

Jan 10, 2019Actual

Name	Class
InGeneron, Inc.	INDUSTRY

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

The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.

Detailed Description

Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.

Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.

Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autologous Cell	Experimental	Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.	Procedure: Autologous Cell
Control	Sham Comparator	Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).	Procedure: Standard microfracture arthroscopic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous Cell	Procedure		Autologous Cell
Standard microfracture arthroscopic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Magnetic Resonance Imaging (MRI) for osteochondral defect filling	Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Pain Scores on Numerical Rating Scale		up to 1 year
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)	Survey	12 months postop

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects undergoing microfracture surgery for the repair of articular cartilage
Osteochondral defect Grade III or IV
Age 18 to 68 years
Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
Written informed consent
Ability to speak, read and write English or Spanish

Exclusion Criteria:

Inability to speak, read and write English or Spanish
Evidence of malignant disorder/neoplasm in past 24 months
History of basal cell carcinoma
History of smoking and not committed to give up
Chronic skin conditions
Connective, metabolic or skin disease
Evidence of active infection
Pregnancy or lactating for female subjects
Diabetes Type I or II
Current steroid use
Immunosuppressive medication
Renal failure (creatine > 1.8 mg/dL)
Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL)
Inflammatory joint diseases of the knee that indicate additional, conflating therapies
Joint infection within the past 6 months
Meniscal resection of greater than 50% prior to, or at time of procedure
Uncorrected joint instability
Joint malalignment > 5 degrees

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert L Burke, MD	Fondren Orthopedic Group L.L.P.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondren Orthopedic Group, L.L.P.		Houston	Texas	77030	United States

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries