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

NCT ID: NCT05060107

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2023-10-05

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group - sEVs

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

Group Type EXPERIMENTAL

Exosomes (sEVs)

Intervention Type BIOLOGICAL

Exosomes 3-5x10e11 particles/dose

Interventions

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Exosomes (sEVs)

Exosomes 3-5x10e11 particles/dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Francisco Espinoza

OTHER

Sponsor Role lead

Responsible Party

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Francisco Espinoza

Medical Chieff Officer, Regenero / C4C

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Jose Matas, MD

Role: CONTACT

+56 2 26183347 ext. 3347

Francisco Espinoza, MD

Role: CONTACT

+56 2 26183347 ext. 3347

Other Identifiers

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C4C060921

Identifier Type: -

Identifier Source: org_study_id

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