Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
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|ClinicalTrials.gov Identifier: NCT01739504|
Recruitment Status : Terminated (company dissolved)
First Posted : December 3, 2012
Last Update Posted : November 24, 2017
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Liposuction with Local Anesthesia Biological: Intra articular infusion of AD-SVF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis|
|Actual Study Start Date :||March 1, 2014|
|Actual Primary Completion Date :||April 1, 2017|
|Actual Study Completion Date :||April 1, 2017|
Experimental: Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
Procedure: Liposuction with Local Anesthesia
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Biological: Intra articular infusion of AD-SVF
Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
- Change from Baseline in Visual Analogue Scale (VAS) [ Time Frame: 3 months, 6 months ]For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
- Change from Baseline of Quality of life scores [ Time Frame: 3 months, and 6 months ]
- Change from Baseline of Reduction in analgesics [ Time Frame: Baseline, 3 months, 6 months ]
- Number of adverse events reported [ Time Frame: 6 months ]
- Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline. [ 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): NCT01739504
|United States, Florida|
|Ageless Institute LLC|
|Aventura, Florida, United States, 33180|
|Principal Investigator:||Sharon McQuillan, MD||Ageless Regenerative Institute|