SVF Therapy for Human Knee Osteoarthritis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: autologous SVF treatment Three milliliter of cell suspension injection containing 1.0E8 SVF cells into the knee joint |
Procedure: SVF treatment
autologous SVF (10E8 cells)
|
| No Intervention: Placebo group No treatment |
Outcome Measures
Primary Outcome Measures
- 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 Volume [Change from Baseline articular cartilage Volume at 24 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 Area [Change from Baseline articular cartilage Area at 24 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.
- 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.
- 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 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 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China | 437200 |
Sponsors and Collaborators
- Zhongnan Hospital
Investigators
- Principal Investigator: Xin Xiao Zheng, MD, Wuhan University
- Study Director: Lin Cai, MD, Wuhan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Zhongnanzxx