Osteoarthritis, Knee
Conditions
Keywords
mesenchymal stromal cells
Brief summary
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
Interventions
BIOLOGICALumbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
Sponsors
Universidad de los Andes, Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient between 30 and 75 years old * Knee-OA Kellgren Lawrence grade I to III * Pain density according to visual analogue scale superior or equal to 50 mm * Patelar condromalacia grade I to III * Stable joint with normal physical exploration
Exclusion criteria
* Bilateral symptomatic disease * Local or systemic infection * Neoplasia * Immunosuppression state * Pregnancy * Anticoagulant therapy * Other types of arthritis * Symptomatic disease of hip and/or spine * Intra-articular infiltration with steroids in the last 3 months * Intra-articular infiltration with hyaluronic acid in the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in WOMAC score | 6 months |
| Change in VAS score | 6 months |
| Changes in structural joint assessment by MRI | 6 months |
Countries
Chile
Contacts
Primary ContactFrancisco Espinoza, MD
Backup ContactRoberto Bobadilla
Outcome results
None listed