Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis, knee, stem cells, mesenchymal, umbilical cord
Brief summary
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.
Detailed description
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).
Interventions
BIOLOGICALHuman umbilical cord tissue-derived mesenchymal stem cells
Sponsors
Translational Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 3 months and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with a change in joint function from baseline WOMAC assessment | 3 months and 12 months |
| Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system | 3 months and 12 months |
Countries
Panama
Outcome results
None listed