. 2018 Mar 6;16:49. doi: 10.1186/s12967-018-1420-z

Table 1.

Subject eligibility criteria

Inclusion criteria	Exclusion 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

Inclusion criteria

Exclusion 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

BMI, body mass index; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; KL, Kellgren–Lawrence; MRI, magnetic resonance imaging; OA, osteoarthritis; PI, principal investigator; VAS, visual analogue scale