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

Primary Purpose

Degenerative Lesion of Articular Cartilage of Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADSC Application
Microfracture
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lesion of Articular Cartilage of Knee focused on measuring 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

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Medical Outpatient Center
  • Kerlan Jobe Orthopedic InstituteRecruiting
  • UC Health Steadman Hawkins Clinic - Denver InvernessRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADSC Application

Microfracture Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Health Scores on the KOOS Questionnaire
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

Activity Level on the Tegner Activity Scale
The Tegner Activity scale, a standard outcome questionnaire for assessment of activity levels, will be completed.
Cartilage Composition Assessment by MRI Scan
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.
Functionality Scores on the Lysholm Scale
The Lysholm Scale, a standard outcome questionnaire for assessment of knee functionality, will be completed.
Pain Scores on the Visual Analog Scale (VAS)
The Visual Analog Scale, a standard outcome questionnaire for assessment of pain levels, will be completed.
Health Scores on Veterans-Rand (VR-12) Survey
The Veterans-Rand survey, a standard outcome questionnaire for assessment of health and quality of life, will be completed.

Full Information

First Posted
March 11, 2014
Last Updated
May 23, 2023
Sponsor
University of Colorado, Denver
Collaborators
University of Kentucky, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02090140
Brief Title
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
Official Title
Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of Kentucky, Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lesion of Articular Cartilage of Knee
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADSC Application
Arm Type
Experimental
Arm Description
Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.
Arm Title
Microfracture Arm
Arm Type
Active Comparator
Arm Description
Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.
Intervention Type
Procedure
Intervention Name(s)
ADSC Application
Intervention Description
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
Intervention Name(s)
Microfracture
Intervention Description
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 Measure Information:
Title
Health Scores on the KOOS Questionnaire
Description
The Knee Osteoarthritis Outcome Score (KOOS), a standard outcome questionnaire for the assessment of health-related quality of life, will be completed.
Time Frame
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Secondary Outcome Measure Information:
Title
Activity Level on the Tegner Activity Scale
Description
The Tegner Activity scale, a standard outcome questionnaire for assessment of activity levels, will be completed.
Time Frame
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Title
Cartilage Composition Assessment by MRI Scan
Description
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.
Time Frame
Assessed at baseline, 6 months, 12 months, and 24 months post-operatively.
Title
Functionality Scores on the Lysholm Scale
Description
The Lysholm Scale, a standard outcome questionnaire for assessment of knee functionality, will be completed.
Time Frame
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Title
Pain Scores on the Visual Analog Scale (VAS)
Description
The Visual Analog Scale, a standard outcome questionnaire for assessment of pain levels, will be completed.
Time Frame
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Title
Health Scores on Veterans-Rand (VR-12) Survey
Description
The Veterans-Rand survey, a standard outcome questionnaire for assessment of health and quality of life, will be completed.
Time Frame
Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Butler
Phone
(720)872-0112
Email
dragoo.lab@ucdenver.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitie Whitney
Phone
(720)872-0112
Email
dragoo.lab@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Dragoo, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth L Sherman, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Medical Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kerlan Jobe Orthopedic Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Galloway, B.S.
Phone
310-829-2663
Email
jasmine.galloway@cskerlanjobe.org
First Name & Middle Initial & Last Name & Degree
Burt Mandelbaum, M.D.
Facility Name
UC Health Steadman Hawkins Clinic - Denver Inverness
City
Denver
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Butler
Phone
720-872-0112
Email
dragoo.lab@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Kaitie Whitney
Phone
(720)872-0112
Email
dragoo.lab@ucdenver.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20360528
Citation
Bedi A, Feeley BT, Williams RJ 3rd. Management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010 Apr;92(4):994-1009. doi: 10.2106/JBJS.I.00895.
Results Reference
background
PubMed Identifier
14996869
Citation
Knutsen G, Engebretsen L, Ludvigsen TC, Drogset JO, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen O. Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial. J Bone Joint Surg Am. 2004 Mar;86(3):455-64. doi: 10.2106/00004623-200403000-00001.
Results Reference
background
PubMed Identifier
12892203
Citation
Dragoo JL, Samimi B, Zhu M, Hame SL, Thomas BJ, Lieberman JR, Hedrick MH, Benhaim P. Tissue-engineered cartilage and bone using stem cells from human infrapatellar fat pads. J Bone Joint Surg Br. 2003 Jul;85(5):740-7.
Results Reference
background
PubMed Identifier
17901063
Citation
English A, Jones EA, Corscadden D, Henshaw K, Chapman T, Emery P, McGonagle D. A comparative assessment of cartilage and joint fat pad as a potential source of cells for autologous therapy development in knee osteoarthritis. Rheumatology (Oxford). 2007 Nov;46(11):1676-83. doi: 10.1093/rheumatology/kem217. Epub 2007 Sep 26.
Results Reference
background
PubMed Identifier
22583627
Citation
Koh YG, Choi YJ. Infrapatellar fat pad-derived mesenchymal stem cell therapy for knee osteoarthritis. Knee. 2012 Dec;19(6):902-7. doi: 10.1016/j.knee.2012.04.001. Epub 2012 May 14.
Results Reference
background
PubMed Identifier
23499511
Citation
Ma A, Jiang L, Song L, Hu Y, Dun H, Daloze P, Yu Y, Jiang J, Zafarullah M, Chen H. Reconstruction of cartilage with clonal mesenchymal stem cell-acellular dermal matrix in cartilage defect model in nonhuman primates. Int Immunopharmacol. 2013 Jul;16(3):399-408. doi: 10.1016/j.intimp.2013.02.005. Epub 2013 Mar 13.
Results Reference
background
PubMed Identifier
23294867
Citation
Giavaresi G, Bondioli E, Melandri D, Giardino R, Tschon M, Torricelli P, Cenacchi G, Rotini R, Castagna A, Veronesi F, Pagani S, Fini M. Response of human chondrocytes and mesenchymal stromal cells to a decellularized human dermis. BMC Musculoskelet Disord. 2013 Jan 7;14:12. doi: 10.1186/1471-2474-14-12.
Results Reference
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PubMed Identifier
23360790
Citation
Desando G, Cavallo C, Sartoni F, Martini L, Parrilli A, Veronesi F, Fini M, Giardino R, Facchini A, Grigolo B. Intra-articular delivery of adipose derived stromal cells attenuates osteoarthritis progression in an experimental rabbit model. Arthritis Res Ther. 2013 Jan 29;15(1):R22. doi: 10.1186/ar4156.
Results Reference
background
PubMed Identifier
23375182
Citation
Koh YG, Jo SB, Kwon OR, Suh DS, Lee SW, Park SH, Choi YJ. Mesenchymal stem cell injections improve symptoms of knee osteoarthritis. Arthroscopy. 2013 Apr;29(4):748-55. doi: 10.1016/j.arthro.2012.11.017. Epub 2013 Jan 29.
Results Reference
background
PubMed Identifier
12838072
Citation
Wickham MQ, Erickson GR, Gimble JM, Vail TP, Guilak F. Multipotent stromal cells derived from the infrapatellar fat pad of the knee. Clin Orthop Relat Res. 2003 Jul;(412):196-212. doi: 10.1097/01.blo.0000072467.53786.ca.
Results Reference
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Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects

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