SVF Therapy for Human Knee Osteoarthritis

Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05019378

Enrollment

Registered

2021-08-24

Start date

2016-12-19

Completion date

2019-01-28

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Cartilage Defect, Cartilage Regeneration

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESVF treatment

autologous SVF (10E8 cells)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Radiologic evaluation of knee articular cartilage Volume	Change from Baseline articular cartilage Volume at 12 weeks	The Volume (cubic millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Area	Change from Baseline articular cartilage Area at 12 weeks	The Area (square millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Thickness	Change from Baseline articular cartilage Thickness at 12 weeks	The Thickness (millimeter) of knee articular cartilage are measured.
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])	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.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)	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.
Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026