Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Exosomes (sEVs)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group - sEVs

Arm Description

Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.

Outcomes

Primary Outcome Measures

Adverse Event

Ocurrence of any adverse reactions within 12 months of treatment

Secondary Outcome Measures

Incidence of injection-related pain according to VAS scale (0-100mm)

Pain measured by VAS scale after first week of treatment

Incidence of injection-related sinovitis according to effusion grading scale of knee joint

Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment

Pain reduction

Change in VAS score after 52 weeks

Disability reduction

Change in Womac subscale related to function (C) after 52 weeks

Percentage of responders

According to OMERACT-OARSI Criteria Index Response after 52 weeks

Full Information

NCT ID

NCT05060107

First Posted

September 14, 2021

Last Updated

September 23, 2021

Sponsor

Francisco Espinoza

1. Study Identification

Unique Protocol Identification Number

NCT05060107

Brief Title

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

Acronym

ExoOA-1

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 5, 2021 (Anticipated)

Primary Completion Date

April 5, 2023 (Anticipated)

Study Completion Date

October 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Francisco Espinoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group - sEVs

Arm Type

Experimental

Arm Description

Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose.

Intervention Type

Biological

Intervention Name(s)

Exosomes (sEVs)

Intervention Description

Exosomes 3-5x10e11 particles/dose

Primary Outcome Measure Information:

Title

Adverse Event

Description

Ocurrence of any adverse reactions within 12 months of treatment

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Incidence of injection-related pain according to VAS scale (0-100mm)

Description

Pain measured by VAS scale after first week of treatment

Time Frame

1 week

Title

Incidence of injection-related sinovitis according to effusion grading scale of knee joint

Description

Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment

Time Frame

1 week

Title

Pain reduction

Description

Change in VAS score after 52 weeks

Time Frame

52 weeks

Title

Disability reduction

Description

Change in Womac subscale related to function (C) after 52 weeks

Time Frame

52 weeks

Title

Percentage of responders

Description

According to OMERACT-OARSI Criteria Index Response after 52 weeks

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jose Matas, MD

Phone

+56 2 26183347

Ext

3347

jmatas@clinicauandes.cl

First Name & Middle Initial & Last Name or Official Title & Degree

Francisco Espinoza, MD

Phone

+56 2 26183347

Ext

3347

fespinoza@clinicauandes.cl

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs