Degenerative Lesion of Articular Cartilage of KneeNCT02090140
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
A study testing ADSC Application and Microfracture in people with Degenerative Lesion of Articular Cartilage of Knee, run by University of Colorado, Denver at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Degenerative Lesion of Articular Cartilage of Knee
- What is being tested?
- ADSC Application and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2015to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
UC Health Steadman Hawkins Clinic - Denver Inverness
Denver, Colorado, 80112
Veronica Butler, 720-872-0112, dragoo.lab@ucdenver.edu
Kaitie Whitney, (720)872-0112, dragoo.lab@ucdenver.edu
- Active, not recruiting
Stanford Medical Outpatient Center
Redwood City, California, 94063
- Recruiting
Kerlan Jobe Orthopedic Institute
Santa Monica, California, 90404
Jasmine Galloway, B.S., 310-829-2663, jasmine.galloway@cskerlanjobe.org
Burt Mandelbaum, M.D.
About this study
Official title: Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
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.
Read the 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.
- Being tested
- ADSC Application, Microfracture
- 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
- Medical subject headings
- Wounds and Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSC ApplicationProcedure or surgery
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.
MicrofractureProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| ADSC Application | Experimental | Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy. Receives: Procedure: ADSC Application |
| Microfracture Arm | Active comparator | Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy. Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Secondary outcomes (5)
Activity Level on the Tegner Activity Scale
The Tegner Activity scale, a standard outcome questionnaire for assessment of activity levels, will be completed.
Measured: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
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.
Measured: Assessed at baseline, 6 months, 12 months, and 24 months post-operatively.
Functionality Scores on the Lysholm Scale
The Lysholm Scale, a standard outcome questionnaire for assessment of knee functionality, will be completed.
Measured: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Pain Scores on the Visual Analog Scale (VAS)
The Visual Analog Scale, a standard outcome questionnaire for assessment of pain levels, will be completed.
Measured: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
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.
Measured: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startNov 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lesion of Articular Cartilage of KneeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Stanford University
- Responsible party
- Sponsor
- Investigators
- Jason Dragoo, MD, Principal investigator, University of Colorado, DenverSeth L Sherman, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090140
- Sponsor's protocol ID
- 19-2838
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2014
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20360528Knutsen 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.
PubMed 14996869Dragoo 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.
PubMed 12892203English 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.
PubMed 17901063Koh 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.
PubMed 22583627Ma 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.
PubMed 23499511Giavaresi 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.
PubMed 23294867Desando 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.
PubMed 23360790Koh 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.
PubMed 23375182Wickham 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.
PubMed 12838072
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
- ClinicalTrials.gov ID
- NCT02090140
- Acronym / sponsor ID
- 19-2838
- Keywords
- cartilage/transplantation, cartilage, articular/injuries, cartilage, articular/surgery, chondrocytes/cytology, knee injuries/surgery, knee joint/surgery, orthopedic procedures/methods, tissue engineering
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Kentucky, Stanford University
- Study start
- Nov 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADSC Application | Experimental | Procedure: ADSC ApplicationPatients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy. |
| Microfracture Arm | Active comparator | Procedure: MicrofracturePatients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSC ApplicationPatients 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. | Procedure or surgery | ADSC Application |
| MicrofractureMicrofracture 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). | Procedure or surgery | Microfracture Arm |
Primary outcome
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.
5 secondary outcomes
Activity Level on the Tegner Activity Scale
Time frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Cartilage Composition Assessment by MRI Scan
Time frame: Assessed at baseline, 6 months, 12 months, and 24 months post-operatively.
Functionality Scores on the Lysholm Scale
Time frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Pain Scores on the Visual Analog Scale (VAS)
Time frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Health Scores on Veterans-Rand (VR-12) Survey
Time frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 20360528Bedi 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.
- Background: PubMed 14996869Knutsen 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.
- Background: PubMed 12892203Dragoo 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.
- Background: PubMed 17901063English 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.
- Background: PubMed 22583627Koh 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.
- Background: PubMed 23499511Ma 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.
- Background: PubMed 23294867Giavaresi 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.
- Background: PubMed 23360790Desando 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.
- Background: PubMed 23375182Koh 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.
- Background: PubMed 12838072Wickham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Dragoo, MD principal investigator
University of Colorado, Denver
Seth L Sherman, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADSC Application and Microfracture in people with Degenerative Lesion of Articular Cartilage of Knee, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaitlyn Whitney ((720) 872-4836, Inverness.clinicaltrials@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Scores on the KOOS Questionnaire (time frame: Completed at baseline, 6 months, 12 months, and 24 months post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02090140, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.