Clinical trial NCT03922490: Lipogems Prospective Study
Official title: Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: 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

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
Secondary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in Marx Activity Rating Scale
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
measure: Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
timeFrame: Baseline, 2-Week post-op, 6-Week post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Riley Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
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