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.
AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Liposuction under tumescent anesthesia for adipose tissue harvesting.
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. * AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment. * Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing.
Ageless Institute LLC
Aventura, Florida, United States
Change from Baseline in Visual Analogue Scale (VAS)
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.
Time frame: 3 months, 6 months
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
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