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

NCT02090140 | Recruiting

• 1 other identifier: 19-2838
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

Secondary Outcomes (5)

• Activity Level on the Tegner Activity Scale

  Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

• Cartilage Composition Assessment by MRI Scan

  Assessed at baseline, 6 months, 12 months, and 24 months post-operatively.

• Functionality Scores on the Lysholm Scale

  Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

• Pain Scores on the Visual Analog Scale (VAS)

  Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

• Health Scores on Veterans-Rand (VR-12) Survey

  Completed at baseline, 6 months, 12 months, and 24 months post-operatively.

Study Arms (2)

ADSC Application

EXPERIMENTAL

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

Procedure: ADSC Application

Microfracture Arm

ACTIVE COMPARATOR

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

Procedure: Microfracture

Interventions

Microfracture 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).

Microfracture Arm

ADSC Application 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.

ADSC Application

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Kentucky: collaborator
• Stanford University: collaborator

Study Sites (3)

Stanford Medical Outpatient Center

Redwood City, California, 94063, United States

ACTIVE NOT RECRUITING

Kerlan Jobe Orthopedic Institute

Santa Monica, California, 90404, United States

RECRUITING

UC Health Steadman Hawkins Clinic - Denver Inverness

Denver, Colorado, 80112, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 20360528 BACKGROUND

• 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.

  PMID: 14996869 BACKGROUND

• 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.

  PMID: 12892203 BACKGROUND

• 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.

  PMID: 17901063 BACKGROUND

• 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.

  PMID: 22583627 BACKGROUND

• 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.

  PMID: 23499511 BACKGROUND

• 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.

  PMID: 23294867 BACKGROUND

• 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.

  PMID: 23360790 BACKGROUND

• 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.

  PMID: 23375182 BACKGROUND

• 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.

  PMID: 12838072 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Knee Injuries

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Leg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Jason Dragoo, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Seth L Sherman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlyn Whitney

CONTACT

(720) 872-4836; Inverness.clinicaltrials@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 18, 2014
• Study Start: November 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)