Lipogems Prospective Study

January 18, 2023 updated by: Hospital for Special Surgery, New York

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
OTHER: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 2-Week post-op, 6-Week post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
Time Frame: Baseline, 2-Week post-op, 6-Week 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)
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
Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
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
Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
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
Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
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
Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms)
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
Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)
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
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)
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2019

Primary Completion (ACTUAL)

February 27, 2020

Study Completion (ACTUAL)

February 27, 2020

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (ACTUAL)

April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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