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

September 23, 2021 updated by: Francisco Espinoza

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months
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)
Time Frame: 1 week
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
Time Frame: 1 week
Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment
1 week
Pain reduction
Time Frame: 52 weeks
Change in VAS score after 52 weeks
52 weeks
Disability reduction
Time Frame: 52 weeks
Change in Womac subscale related to function (C) after 52 weeks
52 weeks
Percentage of responders
Time Frame: 52 weeks
According to OMERACT-OARSI Criteria Index Response after 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Espinoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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