Clinical Efficacy of Exosome in Degenerative Meniscal Injury (KNEEXO)

Eskisehir Osmangazi University

Status and phase: Enrolling; Phase 2

Conditions: Knee Injuries; Knee Pain Swelling; Meniscus; Laceration; Meniscus Injury, Tibial; Knee; Injury, Meniscus (Lateral) (Medial); Meniscus Tear; Arthralgia; Meniscus Lesion; Meniscus; Degeneration

Treatments: Drug: SF-MSC; Drug: SF-MSC-EX

Study type: Interventional

Funder types: Other

Identifiers

NCT05261360

56733164/203

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

SF-MSC-EX Treatment Group (Experimental group's left knees)

Experimental group

Description:

The left knee will receive 1 million cells/kg SF-MSC-EX (Synovial fluid mesenchymal stem cell-derived exosome) by intra-articular injection method.

Treatment:

Drug: SF-MSC-EX

SF-MSC Treatment Group (Experimental group's right knees)

Experimental group

Description:

The right knee will receive 1 million cells/kg SF-MSC (Synovial fluid-derived mesenchymal stem cell) by intra-articular injection method.

Treatment:

Drug: SF-MSC

Control Group

No Intervention group

Description:

Participants who received no treatment were defined as the control group.