Status:
UNKNOWN
Clinical Efficacy of Exosome in Degenerative Meniscal Injury
Lead Sponsor:
Eskisehir Osmangazi University
Collaborating Sponsors:
The Scientific and Technological Research Council of Turkey
Conditions:
Knee; Injury, Meniscus (Lateral) (Medial)
Meniscus Tear
Eligibility:
All Genders
30-50 years
Phase:
PHASE2
Brief 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.
Detailed 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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05261360
Start Date
March 1 2022
End Date
March 1 2025
Last Update
March 4 2022
Active Locations (1)
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1
Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye), 26040