Knee OsteoarthritisPhase 4NCT03922490
Lipogems Prospective Study
A Phase 4 study testing Lipogems Device PLUS debridement and Debridement only in people with Knee Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The purpose of this study is to study the clinical outcomes and effects of the injection of fat-derived stem cells (the scientific name being "adipose derived autologous stem cell transplantation (ADAT)") as an addition to knee arthroscopy in the treatment of knee swelling and pain associated with mild to moderate… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lipogems Device PLUS debridement and Debridement only
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 27 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Knee pain and symptoms for >2 months - clicking, popping, giving way, pain with pivot or torque, pain that is episodic, and pain that is acute and localized to one joint
- Conservative treatment >4 weeks with one or more of:
- Non-steroidal Anti-inflammatory Drugs (NSAIDS) or acetaminophen or contraindication to use of NSAIDs and acetaminophen, Activity limitations, Physical Therapy (PT)
- Hospital for Special Surgery (HSS) MRI demonstrating grade 1-3 knee joint effusion/synovitis based on MRI Osteoarthritis Knee Score (MOAKS) criteria
- K-L grade 0-3 on radiographs and/or cartilage thinning on MRI w/ or w/o meniscal tear
Show all 24Show fewer
- Ability to provide informed consent
- Exclusion Criteria: The patients listed below are excluded due to potential confound factors which may alter clinical outcomes in either treatment group (1,3,4,5 7,8, 11, 12,13), if they may potentially cause a ceiling or floor effect to our clinical outcomes (2,6,) or if the treatment may constitute and undue risk to the patient or be outside of the standard of practice of treatment for that patient (1, 9, 10,14, 15, 16)
- 1. Under 18 years of age or skeletally immature
- 2. Grade 4 radiographic Osteoarthritis (OA) as defined by the K-L classification
- 3. Grade 4 chondral lesion of patellofemoral joint on diagnostic arthroscopy
- 4. Major coronal plane malalignment (>5° valgus or varus deviation)
- 5. Knee ligamentous instability
- 6. Pretreatment Numeric Rating Scale (NRS) pain score of <40 of 100
- 7. Systemic disorders such as diabetes, inflammatory arthritis (Rheumatoid Arthritis (RA), gout, psoriatic arthritis, Calcium Pyrophosphate Deposition Diseases (CPPD)), hematological diseases (coagulopathies),severe cardiovascular diseases, systemic infections, or immunodeficiencies.
- 8. History of septic arthritis
- 9. Ventral hernia (if abdominal donor site)
- 10. Lipomatous neoplasm in region of proposed donor site.
- 11. Current use of anticoagulant medications in the 5 days before surgical intervention
- 12. Recent intra-articular injection of corticosteroids (within 30 days) or
- 13. prior treatment with Hyaluronic acid (HA) in past 6 months.
- 14. Knee surgery within the previous 2 months
- 15. Pregnancy or possible pregnancy
- 16. Epilepsy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
The purpose of this study is to study the clinical outcomes and effects of the injection of fat-derived stem cells (the scientific name being "adipose derived autologous stem cell transplantation (ADAT)") as an addition to knee arthroscopy in the treatment of knee swelling and pain associated with mild to moderate knee osteoarthritis. Management of this condition remains a pervasive problem within orthopaedics. Lipogems is a Food and Drug Administration (FDA) approved technique. Lipogems is the name of the technology used to obtain stem cells from fat that will be aspirated/removed by suction from the abdomen. Fat will be processed to obtain stem cells which will then be injected into the knee after the physician completes knee arthroscopy. The study that we are asking patients to enroll in is important because it will attempt to answer the question about whether fat-derived stem cells added to knee arthroscopy is better, worse or no different than knee arthroscopy alone. Currently, without this study, we do not have an answer to this question.
Read the detailed description
Protocol Outline:
- The patient will undergo a diagnostic knee arthroscopy. This procedure would have been performed regardless of enrollment in the study. During the diagnostic knee arthroscopy, the surgeon will determine whether the patient is eligible to participate in the study.
- If the patient has a torn meniscus, inflamed joint lining or loose fragments in the knee, this will be removed and treated and he/she will still be eligible for the study.
- If, however, the physician determines that the patient needs more invasive treatments (such as cartilage transplantation, meniscal repair, removal of a substantial amount of your meniscus), then he/she will be excluded from the study and will not have fat tissue suctioned from his/her abdomen. The standard of care treatment will then proceed based on the physician's judgement.
- After the surgeon completes the arthroscopic procedure, the recommended amount of fat-derived stem cells (about 2 teaspoons) will be injected into the knee. There will be approximately 1 teaspoon of excess fat derived stem cells, which will be transported to our research facility so that the contents can be stored for later examination.
- After surgery, 5 visits are required by the patient over the following 12 months: at 2 weeks after surgery to monitor his/her incision, at 6 weeks, 12 weeks, 6 months and then finally 12 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- Lipogems Device PLUS debridement, Debridement only
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipogems Device PLUS debridementDevice
Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
Debridement onlyProcedure or surgery
Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) | Experimental | Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). Receives: Device: Lipogems Device PLUS debridement |
| Observation Cohort: Knee Arthroscopy | Other | Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). Receives: Procedure: Debridement only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Secondary outcomes (8)
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in Numerical Pain Rating Scale (NPRS)
Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in Marx Activity Rating Scale
Measures frequency of activity in healthiest and most active state during past year Includes four knee functions, each rated 0-4 total scale range 0-16 (higher score indicates more frequent participation/activity)
Measured: Baseline, 2-Week post-op, 6-Week post-op
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
10-item questionnaire with nine 5-point (as well as a single 11-point) rating scales. The results are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
11-point scale question recalculated to a 5 point scale. only 8 of 10 questions used for scoring calculations (Each sub-score is generated by 4/8 questions) - 4Qs, 5 points each Scale from 0-20 to calculate Global Mental Health Raw Score (higher score means better outcome) Scale from 0-20 to calculate Global Physical Health Raw Score (higher score means better outcome)
The raw scores are then standardized to general population using the "T-score":
Global physical health t-score range: 16.2-67.7 Global mental health t-score range: 21.2-67.6
Measured: Baseline, 2-Week post-op, 6-Week post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start11 Nov 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Why it stopped: Recruitment was suspended due to the COVID pandemic and it was decided not to resume the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riley Williams, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922490
- Sponsor's protocol ID
- 2018-1534
- Status last verified
- Jan 2023
- First submitted
- 10 Apr 2019
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Atukorala I, Kwoh CK, Guermazi A, Roemer F, Boudreau R, Hannon MJ, Hunter DJ. Response to: 'Synovitis in knee osteoarthritis: a precursor or concomitant feature?' by Zeng et al. Ann Rheum Dis. 2015 Oct;74(10):e59. doi: 10.1136/annrheumdis-2015-207800. Epub 2015 Aug 7. No abstract available.
PubMed 26253098Ceserani V, Ferri A, Berenzi A, Benetti A, Ciusani E, Pascucci L, Bazzucchi C, Cocce V, Bonomi A, Pessina A, Ghezzi E, Zeira O, Ceccarelli P, Versari S, Tremolada C, Alessandri G. Angiogenic and anti-inflammatory properties of micro-fragmented fat tissue and its derived mesenchymal stromal cells. Vasc Cell. 2016 Aug 18;8:3. doi: 10.1186/s13221-016-0037-3. eCollection 2016.
PubMed 27547374Fellows CR, Matta C, Zakany R, Khan IM, Mobasheri A. Adipose, Bone Marrow and Synovial Joint-Derived Mesenchymal Stem Cells for Cartilage Repair. Front Genet. 2016 Dec 20;7:213. doi: 10.3389/fgene.2016.00213. eCollection 2016.
PubMed 28066501Jannelli E, Fontana A. Arthroscopic treatment of chondral defects in the hip: AMIC, MACI, microfragmented adipose tissue transplantation (MATT) and other options. SICOT J. 2017;3:43. doi: 10.1051/sicotj/2017029. Epub 2017 Jun 7.
PubMed 28589877Karpinski K, Muller-Rath R, Niemeyer P, Angele P, Petersen W. Subgroups of patients with osteoarthritis and medial meniscus tear or crystal arthropathy benefit from arthroscopic treatment. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):782-796. doi: 10.1007/s00167-018-5086-0. Epub 2018 Aug 20.
PubMed 30128683Koh YG, Kwon OR, Kim YS, Choi YJ, Tak DH. Adipose-Derived Mesenchymal Stem Cells With Microfracture Versus Microfracture Alone: 2-Year Follow-up of a Prospective Randomized Trial. Arthroscopy. 2016 Jan;32(1):97-109. doi: 10.1016/j.arthro.2015.09.010. Epub 2015 Nov 14.
PubMed 26585585Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE. Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1308-1316. doi: 10.1007/s00167-013-2807-2. Epub 2013 Dec 11.
PubMed 24326779MacFarlane LA, Yang H, Collins JE, Jarraya M, Guermazi A, Mandl LA, Martin SD, Wright J, Losina E, Katz JN; MeTeOR Investigator Group. Association of Changes in Effusion-Synovitis With Progression of Cartilage Damage Over Eighteen Months in Patients With Osteoarthritis and Meniscal Tear. Arthritis Rheumatol. 2019 Jan;71(1):73-81. doi: 10.1002/art.40660. Epub 2018 Nov 29.
PubMed 30133187Marchal JA, Picon M, Peran M, Bueno C, Jimenez-Navarro M, Carrillo E, Boulaiz H, Rodriguez N, Alvarez P, Menendez P, de Teresa E, Aranega A. Purification and long-term expansion of multipotent endothelial-like cells with potential cardiovascular regeneration. Stem Cells Dev. 2012 Mar 1;21(4):562-74. doi: 10.1089/scd.2011.0072. Epub 2011 Jun 17.
PubMed 21542697Randelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6.
PubMed 27057170Schiavone Panni A, Vasso M, Braile A, Toro G, De Cicco A, Viggiano D, Lepore F. Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response. Int Orthop. 2019 Jan;43(1):7-13. doi: 10.1007/s00264-018-4182-6. Epub 2018 Oct 3.
PubMed 30280218Striano R. D., Chen H., Bilbool N., Azatullah K., Hilado J., Horan K. Case Study: Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance CellR4 2015; 3 (5): e1690
Tremolada, Carlo. (2017). Mesenchymal Stem Cells and Regenerative Medicine: How Lipogems Technology Make Them Easy, Safe and More Effective to Use. MOJ Biology and Medicine. 2. 10.15406/mojbm.2017.02.00047.
Tremolada C, Ricordi C, Caplan AI, Ventura C. Mesenchymal Stem Cells in Lipogems, a Reverse Story: from Clinical Practice to Basic Science. Methods Mol Biol. 2016;1416:109-22. doi: 10.1007/978-1-4939-3584-0_6.
PubMed 27236668Wang X, Jin X, Han W, Cao Y, Halliday A, Blizzard L, Pan F, Antony B, Cicuttini F, Jones G, Ding C. Cross-sectional and Longitudinal Associations between Knee Joint Effusion Synovitis and Knee Pain in Older Adults. J Rheumatol. 2016 Jan;43(1):121-30. doi: 10.3899/jrheum.150355. Epub 2015 Nov 15.
PubMed 26568597
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
- ClinicalTrials.gov ID
- NCT03922490
- Acronym / sponsor ID
- 2018-1534
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was suspended due to the COVID pandemic and it was decided not to resume the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Posted 10 Feb 2023
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 study the clinical outcomes and effects of the injection of fat-derived stem cells (the scientific name being "adipose derived autologous stem cell transplantation (ADAT)") as an addition to knee arthroscopy in the treatment of knee swelling and pain associated with mild to moderate knee osteoarthritis. Management of this condition remains a pervasive problem within orthopaedics. Lipogems is a Food and Drug Administration (FDA) approved technique. Lipogems is the name of the technology used to obtain stem cells from fat that will be aspirated/removed by suction from the abdomen. Fat will be processed to obtain stem cells which will then be injected into the knee after the physician completes knee arthroscopy. The study that we are asking patients to enroll in is important because it will attempt to answer the question about whether fat-derived stem cells added to knee arthroscopy is better, worse or no different than knee arthroscopy alone. Currently, without this study, we do not have an answer to this question.
Detailed description
Protocol Outline:
- The patient will undergo a diagnostic knee arthroscopy. This procedure would have been performed regardless of enrollment in the study. During the diagnostic knee arthroscopy, the surgeon will determine whether the patient is eligible to participate in the study.
- If the patient has a torn meniscus, inflamed joint lining or loose fragments in the knee, this will be removed and treated and he/she will still be eligible for the study.
- If, however, the physician determines that the patient needs more invasive treatments (such as cartilage transplantation, meniscal repair, removal of a substantial amount of your meniscus), then he/she will be excluded from the study and will not have fat tissue suctioned from his/her abdomen. The standard of care treatment will then proceed based on the physician's judgement.
- After the surgeon completes the arthroscopic procedure, the recommended amount of fat-derived stem cells (about 2 teaspoons) will be injected into the knee. There will be approximately 1 teaspoon of excess fat derived stem cells, which will be transported to our research facility so that the contents can be stored for later examination.
- After surgery, 5 visits are required by the patient over the following 12 months: at 2 weeks after surgery to monitor his/her incision, at 6 weeks, 12 weeks, 6 months and then finally 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) | Experimental | Device: Lipogems Device PLUS debridementExperimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). |
| Observation Cohort: Knee Arthroscopy | Other | Procedure: Debridement onlyObservational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age between 18 and 70 years
- Knee pain and symptoms for >2 months - clicking, popping, giving way, pain with pivot or torque, pain that is episodic, and pain that is acute and localized to one joint
- Conservative treatment >4 weeks with one or more of:
- Non-steroidal Anti-inflammatory Drugs (NSAIDS) or acetaminophen or contraindication to use of NSAIDs and acetaminophen, Activity limitations, Physical Therapy (PT)
- Hospital for Special Surgery (HSS) MRI demonstrating grade 1-3 knee joint effusion/synovitis based on MRI Osteoarthritis Knee Score (MOAKS) criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lipogems Device PLUS debridementLipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy. | Device | Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) |
| Debridement onlyPatients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures. | Procedure or surgery | Observation Cohort: Knee Arthroscopy |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
8 secondary outcomes
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in Numerical Pain Rating Scale (NPRS)
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in Marx Activity Rating Scale
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
Time frame: Baseline, 2-Week post-op, 6-Week post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26253098Atukorala I, Kwoh CK, Guermazi A, Roemer F, Boudreau R, Hannon MJ, Hunter DJ. Response to: 'Synovitis in knee osteoarthritis: a precursor or concomitant feature?' by Zeng et al. Ann Rheum Dis. 2015 Oct;74(10):e59. doi: 10.1136/annrheumdis-2015-207800. Epub 2015 Aug 7. No abstract available.
- Background: PubMed 27547374Ceserani V, Ferri A, Berenzi A, Benetti A, Ciusani E, Pascucci L, Bazzucchi C, Cocce V, Bonomi A, Pessina A, Ghezzi E, Zeira O, Ceccarelli P, Versari S, Tremolada C, Alessandri G. Angiogenic and anti-inflammatory properties of micro-fragmented fat tissue and its derived mesenchymal stromal cells. Vasc Cell. 2016 Aug 18;8:3. doi: 10.1186/s13221-016-0037-3. eCollection 2016.
- Background: PubMed 28066501Fellows CR, Matta C, Zakany R, Khan IM, Mobasheri A. Adipose, Bone Marrow and Synovial Joint-Derived Mesenchymal Stem Cells for Cartilage Repair. Front Genet. 2016 Dec 20;7:213. doi: 10.3389/fgene.2016.00213. eCollection 2016.
- Background: PubMed 28589877Jannelli E, Fontana A. Arthroscopic treatment of chondral defects in the hip: AMIC, MACI, microfragmented adipose tissue transplantation (MATT) and other options. SICOT J. 2017;3:43. doi: 10.1051/sicotj/2017029. Epub 2017 Jun 7.
- Background: PubMed 30128683Karpinski K, Muller-Rath R, Niemeyer P, Angele P, Petersen W. Subgroups of patients with osteoarthritis and medial meniscus tear or crystal arthropathy benefit from arthroscopic treatment. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):782-796. doi: 10.1007/s00167-018-5086-0. Epub 2018 Aug 20.
- Background: PubMed 26585585Koh YG, Kwon OR, Kim YS, Choi YJ, Tak DH. Adipose-Derived Mesenchymal Stem Cells With Microfracture Versus Microfracture Alone: 2-Year Follow-up of a Prospective Randomized Trial. Arthroscopy. 2016 Jan;32(1):97-109. doi: 10.1016/j.arthro.2015.09.010. Epub 2015 Nov 14.
- Background: PubMed 24326779Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE. Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1308-1316. doi: 10.1007/s00167-013-2807-2. Epub 2013 Dec 11.
- Background: PubMed 30133187MacFarlane LA, Yang H, Collins JE, Jarraya M, Guermazi A, Mandl LA, Martin SD, Wright J, Losina E, Katz JN; MeTeOR Investigator Group. Association of Changes in Effusion-Synovitis With Progression of Cartilage Damage Over Eighteen Months in Patients With Osteoarthritis and Meniscal Tear. Arthritis Rheumatol. 2019 Jan;71(1):73-81. doi: 10.1002/art.40660. Epub 2018 Nov 29.
- Background: PubMed 21542697Marchal JA, Picon M, Peran M, Bueno C, Jimenez-Navarro M, Carrillo E, Boulaiz H, Rodriguez N, Alvarez P, Menendez P, de Teresa E, Aranega A. Purification and long-term expansion of multipotent endothelial-like cells with potential cardiovascular regeneration. Stem Cells Dev. 2012 Mar 1;21(4):562-74. doi: 10.1089/scd.2011.0072. Epub 2011 Jun 17.
- Background: PubMed 27057170Randelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6.
- Background: PubMed 30280218Schiavone Panni A, Vasso M, Braile A, Toro G, De Cicco A, Viggiano D, Lepore F. Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response. Int Orthop. 2019 Jan;43(1):7-13. doi: 10.1007/s00264-018-4182-6. Epub 2018 Oct 3.
- BackgroundStriano R. D., Chen H., Bilbool N., Azatullah K., Hilado J., Horan K. Case Study: Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance CellR4 2015; 3 (5): e1690
- Individual participant dataSharing planned: No
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Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
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.
Riley Williams, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipogems Device PLUS debridement and Debridement only in people with Knee Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site 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 24 inclusion and 0 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: stopped early, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale (time frame: Baseline, 2-Week post-op, 6-Week post-op). 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 NCT03922490, which also lists 15 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 10 Feb 2023.