Clinical trial: Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints (NCT03166410)

Eligibility criteria:
Inclusion Criteria:

          1. Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence
             grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review,
             and/or pre-op MRI

          2. Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging
             of CMC OA as diagnosed by X-ray and physical examination

          3. Study Subjects must be willing to voluntarily give written Informed Consent to
             participate in the study and sign the Health Insurance Portability and Accountability
             Act (HIPAA) authorization before any study procedures are performed

          4. Subjects with ASA grade I, II, or III

          5. Males and females 25-85 years old

          6. Subjects must have continued pain in their targeted/treatment joint despite
             conservative therapies for at least 3 months

        Exclusion Criteria:

          1. Subjects that are allergic to lidocaine, epinephrine or valium

          2. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be
             stopped as follows prior to injection; Thrombolytics and anti-platelet medication
             including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for
             3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta®
             (rivaroxaban) for 24 hours

          3. Subjects with systemic immunosuppressant use within six (6) weeks from screening and
             subjects with HIV/viral hepatitis

          4. Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis

          5. Women that are pregnant or planning to become pregnant during the study

          6. Subjects on long term use of oral steroids

          7. History of any chemotherapy or radiation therapy on the targeted/treatment joint or
             adipose harvest site
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment