NCT05060107

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2021

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

September 14, 2021

Last Update Submit

September 23, 2021

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Ocurrence of any adverse reactions within 12 months of treatment

    12 months

Secondary Outcomes (5)

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

    1 week

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

    1 week

  • Pain reduction

    52 weeks

  • Disability reduction

    52 weeks

  • Percentage of responders

    52 weeks

Study Arms (1)

Experimental group - sEVs

EXPERIMENTAL

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

Biological: Exosomes (sEVs)

Interventions

Exosomes (sEVs)BIOLOGICAL

Exosomes 3-5x10e11 particles/dose

Experimental group - sEVs

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic knee OA with VAS \>50mm
  • Knee OA Kellgren-Lawrence grade II to III
  • Chondromalacia grade I to III
  • Stable joint

You may not qualify if:

  • Bilateral symptomatic knee OA
  • Local infection
  • Neoplasia
  • Joint replacement
  • Recent use of local steroids
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Jose Matas, MD

CONTACT

+56 2 26183347jmatas@clinicauandes.cl

Francisco Espinoza, MD

CONTACT

+56 2 26183347fespinoza@clinicauandes.cl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Chieff Officer, Regenero / C4C

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 28, 2021

Study Start

October 5, 2021

Primary Completion

April 5, 2023

Study Completion

October 5, 2023

Last Updated

September 28, 2021

Record last verified: 2021-09