SVF Therapy for Human Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019378
• Other study ID #: Zhongnanzxx
• Status: Completed
• Phase: N/A
• Start date: December 19, 2016
• Est. completion date: January 28, 2019

Study information

• Verified date: August 2021
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 28, 2019
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• SVF treatment
autologous SVF (10E8 cells)

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologic evaluation of knee articular cartilage Volume	The Volume (cubic millimeter) of knee articular cartilage are measured.	Change from Baseline articular cartilage Volume at 12 weeks
Primary	Radiologic evaluation of knee articular cartilage Volume	The Volume (cubic millimeter) of knee articular cartilage are measured.	Change from Baseline articular cartilage Volume at 24 weeks
Primary	Radiologic evaluation of knee articular cartilage Area	The Area (square millimeter) of knee articular cartilage are measured.	Change from Baseline articular cartilage Area at 12 weeks
Primary	Radiologic evaluation of knee articular cartilage Area	The Area (square millimeter) of knee articular cartilage are measured.	Change from Baseline articular cartilage Area at 24 weeks
Primary	Radiologic evaluation of knee articular cartilage Thickness	The Thickness (millimeter) of knee articular cartilage are measured.	Change from Baseline articular cartilage Thickness at 12 weeks
Primary	Radiologic evaluation of knee articular cartilage Thickness	The Thickness (millimeter) of knee articular cartilage are measured.	Change from Baseline articular cartilage Thickness at 24 weeks
Primary	Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])	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.	Change from Baseline WOMAC arthritis index score at 12 weeks.
Primary	Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])	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.	Change from Baseline WOMAC arthritis index score at 24 weeks.
Primary	Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)	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.	Change from Baseline Lysholm Knee Scale score at 12 weeks.
Primary	Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)	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.	Change from Baseline Lysholm Knee Scale score at 24 weeks.