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Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799876
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
InGeneron, Inc.
Information provided by (Responsible Party):
Fondren Orthopedic Group L.L.P.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Articular Cartilage Defect Grade III or IV of the Knee Procedure: Autologous Cell Procedure: Standard microfracture arthroscopic surgery Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Cell Therapy Enhancement of Microfracture Surgery
Study Start Date : February 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous Cell
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
 Procedure: Autologous Cell
Sham Comparator: Control
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
 Procedure: Standard microfracture arthroscopic surgery


Outcome Measures
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Primary Outcome Measures :
  1. Magnetic Resonance Imaging (MRI) for osteochondral defect filling [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Pain Scores on Numerical Rating Scale [ Time Frame: up to 1 year ]
  2. Knee Injury and Osteoarthritis Outcomes Survey (KOOS) [ Time Frame: 12 months postop ]
    Survey

  3. Knee Range of Motion [ Time Frame: up to 1 year ]
  4. Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799876


Locations
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United States, Texas
Fondren Orthopedic Group, L.L.P.
Houston, Texas, United States, 77030
Sponsors and Collaborators
Fondren Orthopedic Group L.L.P.
InGeneron, Inc.
Investigators
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Principal Investigator: Robert L Burke, MD Fondren Orthopedic Group L.L.P.
More Information
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Responsible Party: Fondren Orthopedic Group L.L.P.
ClinicalTrials.gov Identifier: NCT01799876    
Other Study ID Numbers: FOG-TOH125
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Keywords provided by Fondren Orthopedic Group L.L.P.:
knee
cartilage
microfracture
cell therapy
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries