Intervention: Methylprednisolone
Trial phase: Phase 3
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Participants randomized to the bone marrow derived MSC, adipose-derived MSC, or umbilical cord tissue MSC study arms who were further randomized to the control group and received a corticosteroid (CS) injection into the knee joint.
Eligibility criteria:
Inclusion Criteria:

Age greater or equal to 40 but less than or equal to 70 years old
Males and females
Recent knee radiograph of the targeted knee (standing anteroposterior (AP) lateral and sunrise view)
Diagnosis of OA in the targeted knee (radiographic evidence of OA in the medial and/or lateral tibiofemoral compartment, which would include one or more osteophytes on a standard radiograph taken within 3 months)
Continued OA pain in the targeted knee despite conservative measures (per treating provider's discretion)
Average daily Visual Analog Scale (VAS) ≥3
Kellgren-Lawrence system of Grade II, III, or IV
Subjects may have concomitant patellofemoral but they must have stage II or higher generalized knee OA
Females of childbearing potential only, must have a negative pregnancy test done at screening prior to enrollment in the study
Women and men of child-producing potential must agree to use acceptable contraception methods for the duration of the trial such as birth control pills or condoms with spermicide

Exclusion Criteria:

Clinically apparent tense effusion of the targeted knee
Significant valgus/varus deformities (+/- 10 degrees)
Viscosupplementation within 6 months in the targeted knee
Other biologic injection (PRP or stem cell) within 1 year in the targeted knee
Surgery in the targeted knee within the past 6 months (either open or scope)
Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening
Daily opioid use for the past three months
History of malignancy in the previous 5 years prior to study entry, with the exception of in-situ cancers treated only by local excision with curative intent
History of, or ongoing, autoimmune disorder that requires treatment with an immunosuppressive medication
Active, suspected, or prior infection to the joint in the targeted knee
Part of a vulnerable population per Office for Human Research Protections (OHRP) definition (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc.)
Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7 calendar days prior to the procedure
Unwilling to discontinue use of NSAIDS for 5 calendar days after procedure
History of bleeding disorders or inflammatory joint disease
Inability to hold anti-platelet therapy according to treating provider prior to procedure
Subject is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
Uncontrolled diabetes
Subject has an active workers' compensation case in progress with targeted knee
Subject with insufficient amount of subcutaneous tissue
Hemoglobin less than 10g/dL at the time of screening
Leukocytes <3,000/μL; neutrophils <1,500/μL; lymphocytes <800/μL; platelets <100,000/μL at the time of screening
Diagnosis of liver disease as defined by alanine aminotransferase (ALT) >3x the upper limit of age-determined normal (ULN) or total bilirubin > 1.5x ULN
Subjects who have had greater than 3 corticosteroid injections in the targeted knee in the 12 months prior to screening or at the physician's discretion
Subjects with a known diagnosis of osteoporosis
Subjects with anticipated use of systemic corticosteroids during the study period for treatment of a chronic medical condition