Table 1 Subject eligibility criteria

Provide written informed consent

Males or females aged 40–65 years, inclusive

Diagnosed KL grade 1, 2 or 3 knee OA in the study knee

Moderate-severe pain associated with OA in the study knee as measured by a VAS pain score of between 35 and 90 mm inclusive at the screening visit

BMI of 20–30 inclusive

Negative results for virus antibody tests from samples taken at the screening visit:

 HIV 1 and 2 antibody test

 HCV antibody test

 HBV antibody test

Able to read and write in English

A female patient is eligible to enter the study if she meets following criteria:

 Not pregnant or breast feeding/lactating

 Females of non-childbearing potential (i.e., women who had a hysterectomy, had both ovaries surgically removed or have current documentation of tubal ligation, or are postmenopausal which is defined as 1 year without menses)

 Females of childbearing potential must agree to use adequate and highly effective methods of contraception throughout the study

Male patients with female partners of childbearing potential must use adequate and highly effective methods of contraception such as double-barrier form for the entire duration of the study

Inability or unwillingness to comply with protocol requirements

Evidence, or diagnosis, of OA in the non-study knee that is of a worse screening visit VAS score than the study knee

Joint surgery in the study knee, including arthroscopy, within the last 3 years

Consistently occurring major mechanical issues in the study knee including locking, catching and giving way

Intra-articular injections into either knee within the last 3 months

Current evidence of infection in either knee

Diagnosed or symptomatic OA in other major joints (feet, hips, shoulders or spine) that is of greater clinical significance than the study knee

Planned hip, knee, ankle or foot surgery including joint replacement within the expected study duration

History or current evidence of other joint diseases (such as gout, rheumatoid arthritis and ankylosing spondylitis), or disease or medication affecting the bone or cartilage metabolism, including systemic corticosteroids and osteoporosis medication

Unable to undergo an MRI scan for any reason including severe claustrophobia and metal implants such as hip, knee or aortic valve prosthetics

Current smoker, or have been a regular (daily) smoker in the past 3 months

Planned or current participation in any other interventional clinical trials

Patients who require use of systemic immunosuppressants

Any clinically significant condition(s) that in the opinion of the PI may compromise safety or compliance, interfere with evaluation or preclude completion of the study