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Trial · NCT07898501

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRed blood cell contamination of research-only SVFBaseline (procedure day)Red blood cell contamination proportion in research-only SVF.
PrimaryTotal nucleated cell count of research-only SVFBaseline (procedure day)Number of nucleated cells in research-only SVF.
PrimaryMSC-like stromal progenitor cell compositionBaseline (procedure day)Research-only SVF cells with the protocol phenotype CD73+, CD90+, CD146+/CD45-, CD31-.
PrimaryCD34-positive adipose stromal progenitor cell compositionBaseline (procedure day)Research-only SVF CD34+ adipose stromal progenitor cells.
PrimaryResearch-only SVF secretome analyte concentrationsBaseline (procedure day)Individual concentrations of HGF, VEGF-A, IGF-1, IL-1β/IL-1F2, IL-1Ra/IL-1F3, IL-6, IL-10, PGE2, IL-8/CXCL8, MMP-3, MMP-13, and COMP.
PrimaryChange from baseline in synovial fluid biomarker concentrations at 6 monthsImmediately before injection and 6 months after injection
Paired change in each of the same 12 analytes listed in outcome 5. Each analyte is assessed individually. Six-month synovial fluid concentrations are recorded in pg/mL; paired measurements use the same units.
SecondaryChange from baseline in pain VAS at 6 monthsBaseline and 6 months after injectionActivity-related knee pain VAS, 0-10; higher scores indicate greater pain.
SecondaryChange from baseline in WOMAC at 6 monthsBaseline and 6 months after injectionWOMAC total score, 0-96, with pain (0-20), stiffness (0-8), and physical function (0-68) subscales. Higher scores indicate worse symptoms or disability.
SecondaryChange from baseline in KOOS at 6 monthsBaseline and 6 months after injectionKOOS symptoms, pain, activities of daily living, sport/recreation, and knee-related quality-of-life subscales, each 0-100; higher scores indicate better status. Subscales are assessed separately.
SecondaryChange from baseline in IKDC subjective score at 6 monthsBaseline and 6 months after injectionIKDC subjective score, 0-100; higher scores indicate better function and fewer symptoms.
SecondaryChange from baseline in Kellgren-Lawrence grade at 6 monthsBaseline and 6 months after injectionRadiographic Kellgren-Lawrence grade; higher grades indicate greater severity. Baseline grade II/III and six-month grades I-IV are recorded in the CRF.
SecondaryChange from baseline in knee joint space at 6 monthsBaseline and 6 months after injectionMedial and lateral knee joint space widths, recorded separately in millimeters on knee radiographs.
SecondaryChange from baseline in osteophytes at 6 monthsBaseline and 6 months after injectionOsteophyte severity recorded as absent, mild, moderate, or severe. Changes in grade and worsening are assessed.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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