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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05060107

Acronym

ExoOA-1

Enrollment

Registered

2021-09-28

Start date

2021-10-05

Completion date

2023-10-05

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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.

Interventions

BIOLOGICALExosomes (sEVs)

Exosomes 3-5x10e11 particles/dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactJose Matas, MD

jmatas@clinicauandes.cl+56 2 26183347

Backup ContactFrancisco Espinoza, MD

fespinoza@clinicauandes.cl+56 2 26183347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026