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

NCT05060107 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-09-28

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Exosomes (sEVs)

Exosomes 3-5x10e11 particles/dose

Sponsors & Collaborators

  • Francisco Espinoza

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2023-04-05
Completion
2023-10-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060107 on ClinicalTrials.gov