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

Osteoarthritis, Knee Clinical Trial

— CLT-OA1  

Official title:

A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810521
• Other study ID #: CLT-OA1
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Universidad de los Andes, Chile
• Contact: Francisco Espinoza, MD
• Phone: 56226181008
• Email: fespinoza[@]uandes.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells

Locations

Country	Name	City	State
Chile	Clínica Universidad de los Andes	Santiago	Xiii

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		6 months
Secondary	Change in WOMAC score		6 months
Secondary	Change in VAS score		6 months
Secondary	Changes in structural joint assessment by MRI		6 months