SVF Therapy for Human Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: SVF treatment

• Registration Number: NCT05019378
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study Start: 2016-12-19
• Primary Completion: 2018-08-23
• Study Completion: 2019-01-28
• Status Verified: 2021-08
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-21
• Study First Posted: 2021-08-24
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous SVF treatment	SVF treatment	Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint

Primary Outcome Measures

Name	Time	Method
Radiologic evaluation of knee articular cartilage Thickness	Change from Baseline articular cartilage Thickness at 24 weeks	The Thickness (millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Volume	Change from Baseline articular cartilage Volume at 24 weeks	The Volume (cubic millimeter) of knee articular cartilage are measured.
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.
Radiologic evaluation of knee articular cartilage Area	Change from Baseline articular cartilage Area at 24 weeks	The Area (square 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 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.
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.

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China