Safety and Efficacy of Autologous SVF Cells in Treating Patients With Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02846675|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Biological: autologous SVF Biological: Placebo||Phase 1 Phase 2|
The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo.
Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis|
|Actual Study Start Date :||November 1, 2014|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||January 31, 2018|
Experimental: SVF treatment (random knee)
A random knee (left or right) of subjects will be treated with autologous SVF.
Biological: autologous SVF
SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.
Other Name: Stromal Vascular Fraction
Placebo Comparator: placebo treatment (the other knee)
The other knee of subjects will be treated with placebo.
a Placebo treatment without SVF cells
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]Subjects will be monitored for adverse events
- Change in Pain Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]Patients outcomes for pain will be scored through questionaires
- Change in Function Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]Patients outcomes for knee function will be scored through questionaires
- Change from baseline in MRI imaging [ Time Frame: 3 months & 6 months ]Knee function will be assessed by MRI at three time points: pre-op, 3 months and 6 months post-op
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846675
|Shanghai East Hospital|
|Shanghai, Shanghai, China, 200000|