Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1) (ExoOA-1)

A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)

The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: Exosomes (sEVs)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jose Matas, MD; Phone Number: 3347 +56 2 26183347; Email: jmatas@clinicauandes.cl
• Study Contact Backup: Name: Francisco Espinoza, MD; Phone Number: 3347 +56 2 26183347; Email: fespinoza@clinicauandes.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic knee OA with VAS >50mm
• Knee OA Kellgren-Lawrence grade II to III
• Chondromalacia grade I to III
• Stable joint

Exclusion Criteria:

• Bilateral symptomatic knee OA
• Local infection
• Neoplasia
• Joint replacement
• Recent use of local steroids
• BMI > 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group - sEVs; Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.	Biological: Exosomes (sEVs); Exosomes 3-5x10e11 particles/dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Ocurrence of any adverse reactions within 12 months of treatment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of injection-related pain according to VAS scale (0-100mm)	Pain measured by VAS scale after first week of treatment	1 week
Incidence of injection-related sinovitis according to effusion grading scale of knee joint	Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment	1 week
Pain reduction	Change in VAS score after 52 weeks	52 weeks
Disability reduction	Change in Womac subscale related to function (C) after 52 weeks	52 weeks
Percentage of responders	According to OMERACT-OARSI Criteria Index Response after 52 weeks	52 weeks

Collaborators and Investigators

• Sponsor: Francisco Espinoza

Study record dates

Study Major Dates

• Study Start (Anticipated): October 5, 2021
• Primary Completion (Anticipated): April 5, 2023
• Study Completion (Anticipated): October 5, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: C4C060921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No