Back to resultsSVF Therapy for Human Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SVF treatment
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Cartilage Defect, Cartilage Regeneration
Eligibility Criteria
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
Sites / Locations
- Zhongnan Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
autologous SVF treatment
Placebo group
Arm Description
Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint
No treatment
Outcomes
Primary Outcome Measures
Radiologic evaluation of knee articular cartilage Volume
The Volume (cubic millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Volume
The Volume (cubic millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Area
The Area (square millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Area
The Area (square millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Thickness
The Thickness (millimeter) of knee articular cartilage are measured.
Radiologic evaluation of knee articular cartilage Thickness
The Thickness (millimeter) of knee articular cartilage are measured.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05019378
Brief Title
SVF Therapy for Human Knee Osteoarthritis
Official Title
Evaluation of the Autologous Stromal Vascular Fraction Therapy for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
January 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Cartilage Defect, Cartilage Regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous SVF treatment
Arm Type
Experimental
Arm Description
Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint
Arm Title
Placebo group
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Procedure
Intervention Name(s)
SVF treatment
Intervention Description
autologous SVF (10E8 cells)
Primary Outcome Measure Information:
Title
Radiologic evaluation of knee articular cartilage Volume
Description
The Volume (cubic millimeter) of knee articular cartilage are measured.
Time Frame
Change from Baseline articular cartilage Volume at 12 weeks
Title
Radiologic evaluation of knee articular cartilage Volume
Description
The Volume (cubic millimeter) of knee articular cartilage are measured.
Time Frame
Change from Baseline articular cartilage Volume at 24 weeks
Title
Radiologic evaluation of knee articular cartilage Area
Description
The Area (square millimeter) of knee articular cartilage are measured.
Time Frame
Change from Baseline articular cartilage Area at 12 weeks
Title
Radiologic evaluation of knee articular cartilage Area
Description
The Area (square millimeter) of knee articular cartilage are measured.
Time Frame
Change from Baseline articular cartilage Area at 24 weeks
Title
Radiologic evaluation of knee articular cartilage Thickness
Description
The Thickness (millimeter) of knee articular cartilage are measured.
Time Frame
Change from Baseline articular cartilage Thickness at 12 weeks
Title
Radiologic evaluation of knee articular cartilage Thickness
Description
The Thickness (millimeter) of knee articular cartilage are measured.
Time Frame
Change from Baseline articular cartilage Thickness at 24 weeks
Title
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Description
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.
Time Frame
Change from Baseline WOMAC arthritis index score at 12 weeks.
Title
Knee pain evaluation and functional evaluation (the Western Ontario and McMaster University arthritis index [WOMAC])
Description
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.
Time Frame
Change from Baseline WOMAC arthritis index score at 24 weeks.
Title
Knee pain evaluation and functional evaluation (The Lysholm Knee Scoring Scale)
Description
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.
Time Frame
Change from Baseline Lysholm Knee Scale score at 12 weeks.
Title
Knee pain evaluation and functional evaluation (The Lysholm Knee Scale)
Description
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.
Time Frame
Change from Baseline Lysholm Knee Scale score at 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Xiao Zheng, MD
Organizational Affiliation
Wuhan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lin Cai, MD
Organizational Affiliation
Wuhan University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
437200
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
Learn more about this trial
SVF Therapy for Human Knee Osteoarthritis
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