Actively Recruiting

Early Phase 1
Age: 30Years - 70Years
All Genders
NCT06431152

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

Led by Universidad de los Andes, Chile · Updated on 2024-05-29

12

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30 to 70 years.
  • Kellgren-Lawrence grade II - III knee osteoarthritis confirmed by Rosenberg view X-ray.
  • Knee pain with a Visual Analog Scale (VAS) score of 40 mm or higher without surgical indication.
  • If both knees are affected, only the most painful knee will be treated; the other knee should have pain of 20 mm or less on the VAS or be asymptomatic.
  • Stable knee confirmed by normal physical examination.
  • Signed informed consent form.
Not Eligible

You will not qualify if you...

  • Symptomatic osteoarthritis in both knees.
  • Body mass index (BMI) over 30 kg/m2.
  • Joint instability found during physical examination.
  • Mechanical meniscal tear detected on physical examination.
  • Active local or systemic infections.
  • Presence of cancer (neoplasia).
  • Immunosuppression.
  • Pregnancy.
  • Current anticoagulant therapy or coagulation disorders.
  • Inflammatory joint diseases, including autoimmune or crystal-induced arthritis.
  • Presence of joint prosthesis.
  • Symptomatic spine or hip disease.
  • Use of intra-articular steroid therapy within the last 6 months.
  • Use of oral steroid therapy within the last month.
  • Use of intra-articular hyaluronic acid therapy within the last 6 months.
  • Subchondral bone fracture.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinica Universidad de los Andes

Santiago, Las Condes, Chile, 2501

Actively Recruiting

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Research Team

J

Jose Matas, MD

CONTACT

F

Francisco Espinoza, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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