Clinical trial: An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee (NCT04201743)

Eligibility criteria:
Inclusion Criteria:

          -  Age of 21 to 80 years

          -  Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence
             grading scale

        Exclusion Criteria:

          -  Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren
             Lawrence grading scale

          -  BMI greater than 40 kg/m2

          -  Subject has active infection at the injection site

          -  Symptomatic OA of the contralateral knee or of either hip that is not responsive to
             acetaminophen (Tylenol) and requires other therapy.

          -  Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any
             other disorder that is the primary source of their knee pain, including but not
             limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer

          -  Subject has documented history of gout or pseudo-gout

          -  Subject has an autoimmune disease or known history of having Acquired Immunodeficiency
             Syndromes (AIDS) or HIV

          -  Subject has received any of the following to the target knee:

               1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening

               2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint
                  within 12 weeks of treatment

               3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to
                  screening

               4. Has had or is planning to have major surgery or arthroscopy in the target knee
                  within 26 weeks of treatment

          -  History of partial or total knee arthroplasty

          -  Subject has used an investigational drug, device or biologic within 12 weeks prior to
             treatment

          -  Subject has a history of immunosuppressive or chemotherapy in the last 5 years

          -  Subject has had prior radiation at the site

          -  Subject is currently taking narcotic medication for any reason.

          -  Subject is pregnant or plans to become pregnant within 365 days of treatment

          -  Subject has any significant medical condition that, in the opinion of the
             Investigator, would interfere with protocol evaluation and participation

          -  Subject is a worker's compensation patient

          -  Subject is a prisoner
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 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