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Completed

NCT Number: NCT05019378

SVF Therapy for Human Knee Osteoarthritis

The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 437200, China

About this study

Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Knee Osteoarthritis
  • Articular cartilage defect grades I/II of both knee

Exclusion criteria

  • autoimmune or inflammatory arthritis
  • serious medical disorders

Treatment and study plan

SVF treatment

Procedure

autologous SVF (10E8 cells)

Primary outcomes

  1. Radiologic evaluation of knee articular cartilage Volume

    Time frame: Change from Baseline articular cartilage Volume at 12 weeks

    The Volume (cubic millimeter) of knee articular cartilage are measured.

  2. Radiologic evaluation of knee articular cartilage Volume

    Time frame: Change from Baseline articular cartilage Volume at 24 weeks

    The Volume (cubic millimeter) of knee articular cartilage are measured.

  3. Radiologic evaluation of knee articular cartilage Area

    Time frame: Change from Baseline articular cartilage Area at 12 weeks

    The Area (square millimeter) of knee articular cartilage are measured.

  4. Radiologic evaluation of knee articular cartilage Area

    Time frame: Change from Baseline articular cartilage Area at 24 weeks

    The Area (square millimeter) of knee articular cartilage are measured.

  5. Radiologic evaluation of knee articular cartilage Thickness

    Time frame: Change from Baseline articular cartilage Thickness at 12 weeks

    The Thickness (millimeter) of knee articular cartilage are measured.

  6. Radiologic evaluation of knee articular cartilage Thickness

    Time frame: Change from Baseline articular cartilage Thickness at 24 weeks

    The Thickness (millimeter) of knee articular cartilage are measured.

  7. Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])

    Time frame: Change from Baseline WOMAC arthritis index score at 12 weeks.

    Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.

  8. Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])

    Time frame: Change from Baseline WOMAC arthritis index score at 24 weeks.

    Knee pain and functional mobility were assessed using WOMAC arthritis index patient questionnaire including 24 parameters for pain, stiffness and physical function. The values ranging from 0 (minimum) to 240 (maximum) and the lower scores mean a better outcome.

  9. Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)

    Time frame: Change from Baseline Lysholm Knee Scale score at 12 weeks.

    The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.

  10. Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)

    Time frame: Change from Baseline Lysholm Knee Scale score at 24 weeks.

    The Lysholm Knee Scoring Scale questionnaire has been designed to evaluate how patients' knee pain has affected their ability to manage everyday life. The values ranging from 0 (minimum) to 100 (maximum) and the higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 24, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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