Suspended
ExoOA-1A 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)
What is being tested
Exosomes (sEVs)
Biological
Who is being recruted
Arthritis+3
+ Joint Diseases
+ Musculoskeletal Diseases
From 30 to 70 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: October 2021
Summary
Principal SponsorFrancisco Espinoza
Study ContactJose Matas, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: October 5, 2021
Actual date on which the first participant was enrolled.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.
Official TitleA 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)
Principal SponsorFrancisco Espinoza
Study ContactJose Matas, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 30 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee
Criteria
4 inclusion criteria required to participate
Stable joint
Knee OA Kellgren-Lawrence grade II to III
Chondromalacia grade I to III
Symptomatic knee OA with VAS >50mm
6 exclusion criteria prevent from participating
Bilateral symptomatic knee OA
Local infection
Neoplasia
Joint replacement
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalIntra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers