Clinical Efficacy of Exosome in Degenerative Meniscal Injury

Last updated: March 3, 2022
Sponsor: Eskisehir Osmangazi University
Overall Status: Active - Recruiting

Phase

2

Condition

Knee Injuries

Arthritis And Arthritic Pain

Muscle Pain

Treatment

N/A

Clinical Study ID

NCT05261360
56733164/203
  • Ages 30-50
  • All Genders

Study Summary

Comparison of intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes with synovial fluid-derived mesenchymal stem cells on the same patient.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Accepting the Informed Consent Form
  • Degenerative meniscus damage grade 1, 2 or 3 on MRI in both right and left knees, andalso the patient does not want surgical treatment
  • Patients with the same degenerative meniscus grade in both knees
  • Patients with ongoing pain
  • Patients without a history of malignancy
  • Absence of signs of unstable meniscus tear such as snagging or locking
  • Patients with stage 0, 1 or 2 gonarthrosis according to Kellgren-Lawrence gonarthrosisstaging
  • Patients without lower extremity malalignment

Exclusion

Exclusion Criteria:

  • Patients whose treatment method was explained and who did not accept the method
  • Patients outside the working-age range
  • Congenital lesion
  • Patients requiring surgical treatment (e.g. bucket handle tear and locked knee)
  • Active inflammatory or connective tissue disease is thought to affect the patient'spain (eg lupus, rheumatoid arthritis, fibromyalgia)
  • Local or systemic infection
  • Pregnant or breastfeeding women
  • Active endocrine disorder that may affect the assessment of patient's pain (eg,hypothyroidism, diabetes)
  • Active neurological disorder that may affect the assessment of the patient's pain (eg,peripheral neuropathy, multiple sclerosis)
  • Active heart disease
  • Presence of a pacemaker
  • Conditions where MR-I is contraindicated
  • Patients with stage 3 or 4 gonarthrosis according to Kellgren-Lawrence gonarthrosisstaging
  • Patients with lower extremity malalignment
  • Patients with signs of unstable meniscus tear such as snagging or locking

Study Design

Total Participants: 30
Study Start date:
March 01, 2022
Estimated Completion Date:
March 31, 2025

Study Description

Mesenchymal stem cell-derived exosomes will be developed and patented as an advanced technology platform as an autologous treatment protocol to repair damaged cartilage tissue. The fact that this treatment is obtained from an autologous source will significantly contribute to the literature in the field of personalized therapy (personalized medicine) and will pave the way for discoveries. Experiences from clinical trials may guide the use of MSC exosomes in other tissue and cell damaged pathologies and immune pathologies or chronic inflammatory diseases.

This study was supported by a grant (1004, 20AG031) from The Scientific and Technological Research Council of Turkey (TUBITAK).

Connect with a study center

  • Eskisehir Osmangazi University

    Eskisehir, 26040
    Turkey

    Active - Recruiting

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