Lipogems Prospective Study

NCT ID: NCT03922490

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-02-27

Brief 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 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)

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).

Group Type: EXPERIMENTAL

Lipogems Device PLUS debridement

Intervention Type: DEVICE

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.

Observation Cohort: Knee Arthroscopy

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).

Group Type: OTHER

Debridement only

Intervention Type: PROCEDURE

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.

Interventions

Lipogems Device PLUS debridement

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.

Intervention Type: DEVICE

Debridement only

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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
• Ability to provide informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riley Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26253098 (View on PubMed)

Ceserani 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.

Reference Type: BACKGROUND

PMID: 27547374 (View on PubMed)

Fellows 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.

Reference Type: BACKGROUND

PMID: 28066501 (View on PubMed)

Jannelli 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.

Reference Type: BACKGROUND

PMID: 28589877 (View on PubMed)

Karpinski 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.

Reference Type: BACKGROUND

PMID: 30128683 (View on PubMed)

Koh 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.

Reference Type: BACKGROUND

PMID: 26585585 (View on PubMed)

Koh 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.

Reference Type: BACKGROUND

PMID: 24326779 (View on PubMed)

MacFarlane 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.

Reference Type: BACKGROUND

PMID: 30133187 (View on PubMed)

Marchal 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.

Reference Type: BACKGROUND

PMID: 21542697 (View on PubMed)

Randelli 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.

Reference Type: BACKGROUND

PMID: 27057170 (View on PubMed)

Schiavone 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.

Reference Type: BACKGROUND

PMID: 30280218 (View on PubMed)

Striano 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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27236668 (View on PubMed)

Wang 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.

Reference Type: BACKGROUND

PMID: 26568597 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-1534

Identifier Type: -

Identifier Source: org_study_id