Lipogems Prospective Study

NCT03922490 | Terminated Phase 4 Results FDA Device

• 1 other identifier: 2018-1534
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, 2-Week post-op, 6-Week post-op

Secondary Outcomes (8)

• Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms

  Baseline, 2-Week post-op, 6-Week post-op

• Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)

  Baseline, 2-Week post-op, 6-Week post-op

• Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)

  Baseline, 2-Week post-op, 6-Week post-op

• Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)

  Baseline, 2-Week post-op, 6-Week post-op

• Change in International Knee Documentation Committee (IKDC) Subjective Knee Form

  Baseline, 2-Week post-op, 6-Week post-op

Study Arms (2)

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).

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).

Procedure: Debridement only

Interventions

Lipogems Device PLUS debridement 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.

Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)

Debridement only 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.

Observation Cohort: Knee Arthroscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Under 18 years of age or skeletally immature
• \. Grade 4 radiographic Osteoarthritis (OA) as defined by the K-L classification
• \. Grade 4 chondral lesion of patellofemoral joint on diagnostic arthroscopy
• \. Major coronal plane malalignment (\>5° valgus or varus deviation)
• \. Knee ligamentous instability
• \. Pretreatment Numeric Rating Scale (NRS) pain score of \<40 of 100
• \. 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.
• \. History of septic arthritis
• \. Ventral hernia (if abdominal donor site)
• \. Lipomatous neoplasm in region of proposed donor site.
• \. Current use of anticoagulant medications in the 5 days before surgical intervention
• \. Recent intra-articular injection of corticosteroids (within 30 days) or
• \. prior treatment with Hyaluronic acid (HA) in past 6 months.
• \. Knee surgery within the previous 2 months
• \. Pregnancy or possible pregnancy

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (15)

• 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.

  PMID: 26253098 BACKGROUND

• 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.

  PMID: 27547374 BACKGROUND

• 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.

  PMID: 28066501 BACKGROUND

• 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.

  PMID: 28589877 BACKGROUND

• 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.

  PMID: 30128683 BACKGROUND

• 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.

  PMID: 26585585 BACKGROUND

• 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.

  PMID: 24326779 BACKGROUND

• 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.

  PMID: 30133187 BACKGROUND

• 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.

  PMID: 21542697 BACKGROUND

• 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.

  PMID: 27057170 BACKGROUND

• 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.

  PMID: 30280218 BACKGROUND

• 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

  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.

  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.

  PMID: 27236668 BACKGROUND

• 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.

  PMID: 26568597 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Debridement

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

Due to COVID, recruiting patients has been difficult. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. Even though Dr. Williams prescreens patients himself for this study, without an RA it has made things much more difficult. At the moment we are in the hiring process and hope this changes for the next continuing review. There have been no changes since the last time.

Results Point of Contact

• Title: Jessica Rios
• Organization: Hospital for Special Surgery

riosj@hss.edu

212-774-7321

Study Officials

• Riley Williams, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 22, 2019
• Study Start: November 11, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)