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EXO-OA01Administration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee: Safety Determination in a Pilot Dose-escalation Study

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What is being tested

UC-MSC sEV

Biological
Who is being recruted

From 30 to 70 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorUniversidad de los Andes, Chile
Study ContactJose Matas, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2024

Actual date on which the first participant was enrolled.

This study is exploring a new treatment for knee osteoarthritis (OA) using a special type of product called small extracellular vesicles (sEV) derived from umbilical cord mesenchymal stem cells. These vesicles are being tested on patients with specific knee OA symptoms to determine if they are safe and effective. The study is important because it could lead to a new treatment option for knee OA, a condition that affects many people and can cause significant pain and mobility issues. Participants in the study will receive a single injection directly into their knee joint. The injection contains the sEV product, which is carefully prepared and administered shortly after its creation to ensure quality. The study will closely monitor participants for any immediate reactions or side effects, including pain and inflammation, at various intervals after the injection. The goal is to identify any safety concerns and determine the best dose for future studies. Researchers will also evaluate changes in participants' knee pain and function over the course of a year.

Official TitleAdministration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee: Safety Determination in a Pilot Dose-escalation Study
NCT06431152
Principal SponsorUniversidad de los Andes, Chile
Study ContactJose Matas, MDMore contacts
Last updated: January 28, 2026
Sourced 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

12 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.
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.

Criteria

6 inclusion criteria required to participate
Age 30 to 70 years.
Kellgren-Lawrence grade II - III knee OA (Rosenberg view x-ray)
VAS for pain ≥ 40 mm, without surgical indication in the affected knee.
In case of bilateral involvement, the most affected knee will be treated. The contralateral knee should be asymptomatic or present a VAS ≤ 20 mm.
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8 exclusion criteria prevent from participating
Symptomatic bilateral knee OA
BMI > 30 kg/m2
Joint instability at physical examination.
Mechanical meniscal tear on physical examination.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intra-articular knee injection of exosomes (2 x 10e10 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients

Group II

Experimental
Intra-articular knee injection of exosomes (2 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients

Group III

Experimental
Intra-articular knee injection of exosomes (6 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients

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 1 location

Recruiting

Clinica Universidad de los Andes

Santiago, ChileOpen Clinica Universidad de los Andes in Google Maps
Recruiting
One Study Center