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Lipogems Prospective Study

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ClinicalTrials.gov Identifier: NCT03922490
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Lipogems Device PLUS debridement Procedure: Debridement only Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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).
Device: 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.

Observation Cohort: Knee Arthroscopy
Observational Group: will undergo diagnostic knee arthscropy (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
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.




Primary Outcome Measures :
  1. Change in Knee Injury and Osteoarthritis Outcome (KOOS) pain subscale [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)


Secondary Outcome Measures :
  1. Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)

  2. Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)

  3. 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, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)

  4. Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)

  5. Change in International Knee Documentation Committee (IKDC) Subjective Knee Form [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms)

  6. Change in Numerical Pain Rating Scale (NPRS) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)

  7. Change in Marx Activity Rating Scale [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    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)

  8. 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, 12-Week post-op, 24-Week post-op, 1 year post-op ]

    Measures symptoms, functioning and quality of life Includes 10 questions measuring general domains of health and functioning (9 question have scale range 1-5; higher score indicating higher level of health or functioning)

    (1 question has scale range 0-10; 0: No pain - 10: worst imaginable pain)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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: 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922490


Contacts
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Contact: Tyler Warner 2126061693 warnert@hss.edu
Contact: Riley Williams, MD 2126061855

Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Riley Williams, MD Hospital for Special Surgery, New York

Publications:
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
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.

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03922490     History of Changes
Other Study ID Numbers: 2018-1534
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases