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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Adipose-derived Stromal Vascular Fraction infusion | Experimental | Intervention: AD-SVF infusion directly into affected joints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction with Local Anesthesia | Procedure | Liposuction under tumescent anesthesia for adipose tissue harvesting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months |
| Change from Baseline of Quality of life scores | 3 months, and 6 months | |
| Change from Baseline of Reduction in analgesics | Baseline, 3 months, 6 months | |
| Number of adverse events reported | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon McQuillan, MD | Ageless Regenerative Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageless Institute LLC | Aventura | Florida | 33180 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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|
| Intra articular infusion of AD-SVF | Biological | 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.
|
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |