Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis

Phase 1

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: umbilical cord derived-mesenchymal stromal cells

• Registration Number: NCT03810521
• Lead Sponsor: Universidad de los Andes, Chile

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-18
• Last Update Posted: 2019-01-18
• Study Start: 2019-03-01
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLT low-dose	umbilical cord derived-mesenchymal stromal cells	Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
CLT high-dose	umbilical cord derived-mesenchymal stromal cells	Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
CLT medium-dose	umbilical cord derived-mesenchymal stromal cells	Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	6 months

Secondary Outcome Measures

Name	Time	Method
Change in VAS score	6 months
Change in WOMAC score	6 months
Changes in structural joint assessment by MRI	6 months

Trial Locations

Locations (1)

Clínica Universidad de los Andes; 🇨🇱 Santiago, Xiii, Chile