Clinical Efficacy of Exosome in Degenerative Meniscal Injury

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eskisehir Osmangazi University
• Collaborator: The Scientific and Technological Research Council of Turkey

Criteria

Inclusion Criteria:

• Accepting the Informed Consent Form

• Degenerative meniscus damage grade 1, 2 or 3 on MRI in both right and left knees, and also 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 gonarthrosis staging

• Patients without lower extremity malalignment

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's pain (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 gonarthrosis staging

• Patients with lower extremity malalignment

• Patients with signs of unstable meniscus tear such as snagging or locking