Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once
 per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect
 in osteoarthritis (OA) patients.
The proposed study will assess primarily safety and secondary efficacy endpoints of
 allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with
 OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will
 receive IV UC-MSC once per day for 3 consecutive days.

 The primary objective of the trial is freedom from treatment associated adverse events at 3
 and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline,
 and 3 and 12 months post treatment and will be quantified based on the Western Ontario and
 McMaster osteoarthritis index (WOMAC).
Inclusion Criteria:

 -  Signed informed consent by the subject.

 -  Age greater than or equal to 18 years

 -  Ability to understand the planned treatment.

 -  Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic
 severity, as defined by the modified Kellgren-Lawrence classification

 Exclusion Criteria:

 -  Pregnant or lactating women

 -  Women of childbearing potential unwilling to use two forms of contraception

 -  Cognitively impaired adults.

 -  Presence of large meniscal tears ("bucket handle" tears), as detected by clinical
 examination or by magnetic resonance imaging.

 -  Inflammatory or postinfectious arthritis.

 -  More than 5 degrees of varus or valgus deformity.

 -  Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral
 compartments of the tibiofemoral joint or the patellofemoral compartment) in persons
 over 60 years of age.

 -  Intraarticular corticosteroid injection within the previous 3 months.

 -  A major neurologic deficit.

 -  Serious medical illness with a life expectancy of less than 1 year.

 -  Prior admission for substance abuse

 -  Body Mass Index (BMI) of 40 kg/m2 or greater

 -  Patient receiving experimental medication or participating in another clinical study
 within 30 days of signing the informed consent

 -  In the opinion of the investigator or the sponsor the patient is unsuitable for
 cellular therapy