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Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects

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ClinicalTrials.gov Identifier: NCT02090140
Recruitment Status : Recruiting
First Posted : March 18, 2014
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Brief Summary:
The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.

Condition or disease Intervention/treatment Phase
Degenerative Lesion of Articular Cartilage of Knee Procedure: ADSC Application Procedure: Microfracture Not Applicable

Detailed Description:

Patients enrolled in the ADSC cohort will undergo the following procedures: arthroscopic resection of approximately 5cc of the infrapatellar fat pad using a motorized shaver (standard use in arthroscopy). Fat will be collected in a sterile Aquavage Collection System (AV1200, MD Resources, Livermore, CA) and kept sealed until processing. Fat will then immediately be processed in the Harvest Adiprep System to separate a population of ADSCs. This system concentrates an average of 5 x 105 cells/ml. All specimens will be processed using routine sterile procedures within the operating room; cells destined for implantation will not leave the operating room. Concurrently, patients will undergo arthroscopy and similar preparation of the chondral defect and removal of the calcified cartilage layer. However, no puncture of the subchondral bone will be performed. A layer of fibrin glue (Tisseel) will be placed at the base of the defect to seal off any bleeding from the subchondral plate followed by the application of the acellular dermal matrix (Allopatch HD, MTF Corporation, Edison, NJ, USA)and ADSCs. An additional layer of Tisseel will then be applied over the cells and matrix. No additional fixation will be applied. The matrix and cells will be recessed below the articular surface by an average of 1mm.

They will then complete outcome questionnaires and additional MRI scans at 6, 12, and 24 months post-operatively.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
Study Start Date : November 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: ADSC Application
Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.
Procedure: ADSC Application
Patients will undergo arthroscopic resection of approximately 5cc of the infrapatellar fat pad, which will be collected for processing for a population of ADSCs. Patients will undergo arthroscopy and preparation of the chondral defect and removal of the calcified cartilage layer. Tisseel Fibrin glue will be placed at the base of the defect side, followed by the application of the acellular collagen dermal matrix, ADSCs, and an additional layer of fibrin glue.

Active Comparator: Microfracture Arm
Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.
Procedure: Microfracture
Microfracture surgery is the standard of care for articular cartilage lesions. Patients will undergo arthroscopy with standard technique of microfracture preparation, including the creation of vertical, stable defect edges and removal of the calcified cartilage layer. A microfracture awl will then be used to perform the microfracture technique (6mm below the subchondral plate).




Primary Outcome Measures :
  1. Health Scores on the KOOS Questionnaire [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]
    The Knee Osteoarthritis Outcome Score (KOOS), a standard outcome questionnaire for the assessment of health-related quality of life, will be completed.


Secondary Outcome Measures :
  1. Activity Level on the Tegner Activity Scale [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]
    The Tegner Activity scale, a standard outcome questionnaire for assessment of activity levels, will be completed.

  2. Cartilage Composition Assessment by MRI Scan [ Time Frame: Assessed at baseline, 6 months, 12 months, and 24 months post-operatively. ]
    Magnetic resonance imaging scans consisting of routine clinical sequences and T2 and T1p quantitative maps will be conducted. T1p and T2 mapping will be used to assess regenerative cartilage composition compared to surrounding normal cartilage, surface integrity, average cartilage thickness, and the percentage to which the defect is filled.

  3. Functionality Scores on the Lysholm Scale [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]
    The Lysholm Scale, a standard outcome questionnaire for assessment of knee functionality, will be completed.

  4. Pain Scores on the Visual Analog Scale (VAS) [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]
    The Visual Analog Scale, a standard outcome questionnaire for assessment of pain levels, will be completed.

  5. Health Scores on Veterans-Rand (VR-12) Survey [ Time Frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively. ]
    The Veterans-Rand survey, a standard outcome questionnaire for assessment of health and quality of life, will be completed.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be between ages 18 and 50 years.
  • Must have a discrete, contained chondral defect less than 400mm^2 located on the medial or lateral femoral condyle
  • Must have overall neutral lower limb mechanical alignment (<5 degrees varus or valgus).

Exclusion Criteria:

  • Ages younger than 18 years and older than 50 years.
  • If they have undergone previous chondral procedures
  • If they have pre-existing osteoarthritis (Kellegren-Lawrence Grade ≥2)
  • If they have a BMI >30.

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): NCT02090140


Contacts
Contact: Michelle Backer (650) 721-7653 mbacker@stanford.edu
Contact: JR Yabut (650) 721-7780 jayabut@stanfordmed.org

Locations
United States, California
Stanford Medical Outpatient Center Recruiting
Redwood City, California, United States, 94063
Contact: Jan Yabut    650-721-7780    jayabut@stanfordmed.org   
Principal Investigator: Jason Dragoo, MD         
Sponsors and Collaborators
Stanford University
University of Kentucky
Investigators
Principal Investigator: Jason Dragoo, MD Stanford University

Publications:

Responsible Party: Jason L. Dragoo, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02090140     History of Changes
Other Study ID Numbers: 27561
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Jason L. Dragoo, Stanford University:
cartilage/transplantation
cartilage, articular/injuries
cartilage, articular/surgery
chondrocytes/cytology
knee injuries/surgery
knee joint/surgery
orthopedic procedures/methods
tissue engineering
tissue scaffolds
arthroscopy/methods
chondrocytes/transplantation
adipose tissue/cytology
cartilage, articular/cytology
chondrogenesis/physiology
osteogenesis/physiology
stem cell transplantation/methods
stem cells
tissue engineering/methods
cartilage, articular/pathology
chondrocytes/pathology
knee joint/pathology
platelet-rich plasma

Additional relevant MeSH terms:
Fractures, Stress
Cartilage Diseases
Fractures, Bone
Wounds and Injuries
Musculoskeletal Diseases
Connective Tissue Diseases