Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- Translational Biosciences
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: 3 months and 12 months
Secondary Outcomes
- 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)