Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Autologous Cell Therapy Enhancement of Microfracture Surgery

Conditions
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Articular Cartilage Defect Grade III or IV of the Knee

Intervention / Treatment
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* Procedure: Autologous Cell
* Procedure: Standard microfracture arthroscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Cell<br>Regenerative cells obtained from autologous fat are administered in the knee at microfracture site. | Procedure: Autologous Cell<br> <br> |
| Sham Comparator: Control<br>Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested). | Procedure: Standard microfracture arthroscopic surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 
| Knee Range of Motion |  | up to 1 year | 
| Number of Patients with Adverse Events as a Measure of Safety |  | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, cartilage, microfracture, cell therapy