A Phase I/II, Randomized, Double-blind, Controlled Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in Patients With Knee Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- umbilical-cord mesenchymal stromal cells
- Conditions
- Osteoarthritis
- Sponsor
- Francisco Espinoza, MD
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Proportion of patients who experience an adverse event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.
Investigators
Francisco Espinoza, MD
Alternative Investigator
Universidad de los Andes, Chile
Eligibility Criteria
Inclusion Criteria
- •Symptomatic Knee OA, Kellgren and Lawrence grade I, II, III on plain Rx films.
- •Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.
- •Stable knee and normal clinical exam of involved extremity
- •Written informed consent for patients.
Exclusion Criteria
- •Bilateral symptomatic knee OA
- •Local or systemic infection.
- •Active neoplasia or immunosuppressive state
- •Pregnancy or Breastfeeding
- •Body Mass Index ≥ 30
- •Presence of Pacemaker or Lower extremity metal implant
- •Anticoagulant treatment other than aspirin.
- •Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids
- •Concomitant inflammatory joint disease (cristal, connective tissue disease)
- •Valgus (\>10o) or Varus (\>5o) deformity of involved extremity
Arms & Interventions
Umbilical-cord mesenchymal stromal cells
Umbilical-cord mesenchymal stromal cells (UC-MSCs) Allogeneic UC-MSCs 20 x 10e6 diluted on 3 mL of saline solution + 5% of Plasma AB Arm 2a: single infusion group. UC-MSCs at 0 month Arm 2b: double infusion group. UC-MSCs at 0 and 6 months
Intervention: umbilical-cord mesenchymal stromal cells
Hyaluronic Acid (HA)
Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months
Intervention: Hyaluronic Acid
Outcomes
Primary Outcomes
Proportion of patients who experience an adverse event
Time Frame: 12 months
according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)
Secondary Outcomes
- Physical function improvement measured by WOMAC OA index(12 months)
- Change in pain density measured by Visual analogue scale (VAS)(12 months)
- QoL improvement measured by SF-36(12 months)
- Changes in WORMS scale measured by knee MRI(12 months)