Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis

NCT06431152 | Recruiting Early Phase 1

• 1 other identifier: EXO-OA01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. The investigators expect to enroll 12 patients in this phase 1 trial open label dose-escalation pilot and the follow-up will be up to 12 months.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  Occurrence of any adverse reactions within 12 months of treatment

  12 month

Secondary Outcomes (5)

• Incidence of injection-related pain according to Visual Analogue Scale (VAS) (0-100mm)

  1-2 weeks

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

  1-2 weeks

• Pain change

  12 months

• Disability change

  12 months

• Percentage of responders

  52 weeks

Study Arms (3)

Low-Dose

EXPERIMENTAL

Intra-articular knee injection of exosomes (2 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients

Biological: UC-MSC sEV

Medial-Dose

EXPERIMENTAL

Intra-articular knee injection of exosomes (6 x 10e9 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients

Biological: UC-MSC sEV

High-Dose

EXPERIMENTAL

Intra-articular knee injection of exosomes (2 x 10e10 particles/dose) derived from allogeneic mesenchymal stromal cells. Single dose. 4 patients

Biological: UC-MSC sEV

Interventions

UC-MSC sEV BIOLOGICAL

Small extracellular vesicles derived from allogenic mesenchymal stromal cells, single dose

Also known as: Cellistem®sEV-OA

High-Dose; Low-Dose; Medial-Dose

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 to 70 years.
• Kellgren-Lawrence grade II - III knee OA (Rosenberg view x-ray)
• VAS for pain ≥ 40 mm, without surgical indication in the affected knee.
• In case of bilateral involvement, the most affected knee will be treated. The contralateral knee should be asymptomatic or present a VAS ≤ 20 mm.
• Stable knee with normal physical examination.
• Signed Informed Consent

You may not qualify if:

• Symptomatic bilateral knee OA
• BMI \> 30 kg/m2
• Joint instability at physical examination.
• Mechanical meniscal tear on physical examination.
• Associated conditions: active local or systemic infection, neoplasia, immunosuppression, pregnancy, anticoagulant therapy, coagulation disorders, inflammatory joint disease (autoimmune, by crystal or other), joint prosthesis, symptomatic spine or hip disease.
• Recent use of intra-articular (last 6 months) or oral (last month) steroid therapy.
• Recent use of intra-articular hyaluronic acid therapy (last 6 months)
• Subchondral bone fracture.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

Clinica Universidad de los Andes

Santiago, Las Condes, 2501, Chile

RECRUITING

Central Study Contacts

Jose Matas, MD

CONTACT

+56 2 26183347; jmatas@clinicauandes.cl

Francisco Espinoza, MD

CONTACT

+56 2 26183347; fespinoza@clinicauandes.cl

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 28, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)