Clinical trial: An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis (NCT02318511)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with moderate knee osteoarthritis determined by a combination of clinical and
             radiographic findings and documented by Kellgren-Lawrence radiographic classification
             (Grade 2 or 3)

          -  Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes,
             possible narrowing of joint space

          -  Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple
             osteophytes, definite narrowing of joints space, some sclerosis and possible deformity
             of bone contour.

          -  Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have
             bilateral symptoms may have their more symptomatic knee injected. If equivalent
             symptoms are reported by the patient, then the patient will choose which knee is to be
             injected. The contralateral knee can be treated with local standard of care such as
             steroid injection, cold therapy or soft brace.

          -  Age 18 and older

          -  BMI less than 40

          -  7 day average pain score of 4 or greater for the involved knee on a numeric pain scale
             from 1 to 10.

          -  Female patients must be actively practicing a contraception method, abstinence, be
             surgically sterilized, or be postmenopausal

        Exclusion Criteria:

          -  Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15
             days before injection (may take acetaminophen)

          -  Receiving pain medication other than acetaminophen for conditions unrelated to
             osteoarthritis of the index knee

          -  Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of
             antiplatelet medications are not a reason for exclusion

          -  History of substance abuse.

          -  Failure to agree NOT to take additional knee symptom modifying drugs, other than
             acetaminophen, during the course of the study without reporting to the study team

          -  Pregnancy or desire to become pregnant during study duration

          -  Positive pregnancy test on premenopausal subject

          -  Morbid obesity (defined as BMI 40 or greater)

          -  Symptoms of locking, intermittent block to range of motion or loose body sensation
             which could indicate meniscal displacement or an intraarticular loose body

          -  Corticosteroid injection into the index knee within 3 months

          -  Viscosupplement injection into the index knee within 3 months

          -  Knee surgery of involved index knee within 12 months

          -  Knee surgery contralateral knee 6 months

          -  Worker compensation

          -  Acute index knee injury (injury within 3 months)

          -  History of Diabetes mellitus

          -  History of solid organ or hematologic transplantation

          -  History of rheumatoid arthritis or other autoimmune disorder

          -  Diagnosis of a non-basal cell malignancy within the preceding 5 years

          -  Infection requiring antibiotic treatment within the preceding 3 months

          -  Current therapy with any immunosuppressive medication, including corticosteroids at a
             dose > 5 mg per day
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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