Clinical trial NCT01799876: Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
Official title: Autologous Cell Therapy Enhancement of Microfracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Articular Cartilage Defect Grade III or IV of the Knee
Keywords: knee
cartilage
microfracture
cell therapy
Lead sponsor: Fondren Orthopedic Group L.L.P.
Sponsor class: OTHER
Collaborators: name: InGeneron, Inc.
First posted: 2013-02-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI) for osteochondral defect filling
timeFrame: 12 months
Secondary outcomes:
measure: Pain Scores on Numerical Rating Scale
timeFrame: up to 1 year
measure: Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
timeFrame: 12 months postop
measure: Knee Range of Motion
timeFrame: up to 1 year
measure: Number of Patients with Adverse Events as a Measure of Safety
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Fondren Orthopedic Group, L.L.P.
state: Texas
Study officials:
affiliation: Fondren Orthopedic Group L.L.P.
name: Robert L Burke, MD
role: PRINCIPAL_INVESTIGATOR
References: