Status:
COMPLETED
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
Lead Sponsor:
Fondren Orthopedic Group L.L.P.
Collaborating Sponsors:
InGeneron, Inc.
Conditions:
Articular Cartilage Defect Grade III or IV of the Knee
Eligibility:
All Genders
18-68 years
Phase:
NA
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 carti...
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 process...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01799876
Start Date
February 1 2013
End Date
August 1 2017
Last Update
January 10 2019
Active Locations (1)
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1
Fondren Orthopedic Group, L.L.P.
Houston, Texas, United States, 77030