Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

NCT ID: NCT01799876

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-08-31

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.

Conditions

Articular Cartilage Defect Grade III or IV of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Autologous Cell

Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.

Group Type: EXPERIMENTAL

Autologous Cell

Intervention Type: PROCEDURE

Control

Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).

Group Type: SHAM_COMPARATOR

Standard microfracture arthroscopic surgery

Intervention Type: PROCEDURE

Interventions

Autologous Cell

Intervention Type: PROCEDURE

Standard microfracture arthroscopic surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InGeneron, Inc.

INDUSTRY

Sponsor Role: collaborator

Fondren Orthopedic Group L.L.P.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L Burke, MD

Role: PRINCIPAL_INVESTIGATOR

Fondren Orthopedic Group L.L.P.

Locations

Fondren Orthopedic Group, L.L.P.

Houston, Texas, United States

Countries

United States

Other Identifiers

FOG-TOH125

Identifier Type: -

Identifier Source: org_study_id