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

NCT ID: NCT02090140

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ADSC Application

Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.

Group Type: EXPERIMENTAL

ADSC Application

Intervention Type: PROCEDURE

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.

Microfracture Arm

Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.

Group Type: ACTIVE_COMPARATOR

Microfracture

Intervention Type: PROCEDURE

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kentucky

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Dragoo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Seth L Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Medical Outpatient Center

Redwood City, California, United States

Site Status: ACTIVE_NOT_RECRUITING

Kerlan Jobe Orthopedic Institute

Santa Monica, California, United States

Site Status: RECRUITING

UC Health Steadman Hawkins Clinic - Denver Inverness

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kaitlyn Whitney

Role: CONTACT

Inverness.clinicaltrials@cuanschutz.edu

(720) 872-4836

Facility Contacts

Jasmine Galloway, B.S.

Role: primary

jasmine.galloway@cskerlanjobe.org

310-829-2663

Veronica Butler

Role: primary

dragoo.lab@ucdenver.edu

720-872-0112

Kaitie Whitney

Role: backup

dragoo.lab@ucdenver.edu

(720)872-0112

References

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Reference Type: BACKGROUND

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Other Identifiers

19-2838

Identifier Type: -

Identifier Source: org_study_id