Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01885832|
Recruitment Status : Withdrawn (per sponsor decision)
First Posted : June 25, 2013
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Biological: Autologous adipose tissue stromal vascular fraction||Phase 1 Phase 2|
The proposed study is a single center, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) isolated from 500 ml of adipose tissue extracted from the infraumbilical area. The cellular product will be administered via intra-articular injection into patients with moderate to severe osteoarthritis (OA). Administration will be performed by injection into the synovial space. The dosing regimen will consist of two intraarticular injection of autologous SVF into the index knee. Total injection volume will be about 30 mL in two 15 mL aliquots via a 23 gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
The purpose of this study will be to define the safety and efficacy of SVF therapy in improving joint function and the quality of life in patients with OA of the knee. We plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. The primary safety outcome will be tabulation of adverse events related to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2016|
In the treatment arm, autologous stromal vascular fraction (SVF) will be injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity.
Biological: Autologous adipose tissue stromal vascular fraction
- Number of participants with adverse events [ Time Frame: 6 months ]
- Change from baseline Kellgren-Lawrence classification at 6 months [ Time Frame: 6 months ]
- Change from baseline WOMAC Assessment at 6 months [ Time Frame: 6 months ]
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): NCT01885832
|Stem Cell Instsitute|
|Panama City, Panama|
|Principal Investigator:||Jorge Paz-Rodriguez, M.D.||Stem Cell Institute Panama|