Status:
UNKNOWN
Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis
Lead Sponsor:
Universidad de los Andes, Chile
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03810521
Start Date
March 1 2019
End Date
December 30 2019
Last Update
January 18 2019
Active Locations (1)
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1
Clínica Universidad de los Andes
Santiago, XIII, Chile, 7620001