Clinical trial NCT05261360: Clinical Efficacy of Exosome in Degenerative Meniscal Injury
Official title: A Phase II Trial to Investigate Clinical Efficacy of Autologous Synovial Fluid Mesenchymal Stem Cell-Derived Exosome Application in Patients With Degenerative Meniscal Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Knee; Injury, Meniscus (Lateral) (Medial)
Meniscus Tear
Meniscus Lesion
Meniscus; Degeneration
Meniscus; Laceration
Meniscus Injury, Tibial
Knee Injuries
Knee Pain Swelling
Arthralgia
Keywords: Meniscal injury
Exosome
Mesenchymal Stem Cell
Synovial Fluid
Regeneration
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as three arms. One arm will be the control group, and the other two arms will be the experimental group. The control group defines the group that did not receive treatment. Those in the experimental group, who are the participants other than the control group, will occur in both experimental groups. SF-MSC (synovial fluid-derived mesenchymal stem cells) will be applied intraarticularly to the experimental group's right knee, and the experimental group's right knee will be included in the SF-MSC treatment group. SF-MSC-EX (synovial fluid-derived mesenchymal stem cells-derived exosomes) will be applied intraarticularly to the experimental group's left knee, and the experimental group's left knee will be included in the SF-MSC-EX treatment group.
Primary purpose: TREATMENT

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 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).

Eligibility 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

Primary outcomes:
measure: Evaluation of Knee Functions
timeFrame: Up to 12th months
measure: Evaluation of Physical Activity
timeFrame: Up to 12th months
measure: Evaluation of Pain
timeFrame: Up to 12th months
measure: Evaluation of Radiological Images
timeFrame: Up to 12th months
measure: Evaluation of Cytokine Levels and Cytokine Genes Analyzes
timeFrame: Up to 12th months
measure: Evaluation of Edema
timeFrame: Up to 12th months
measure: Evaluation of Knee Joint Range of Motion
timeFrame: Up to 12th months
measure: Monitoring of treatment-related complications
timeFrame: Up to 12th months
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Cell Therapy and Stem Cell Production Application and Research Center (ESTEM)
name: Ayla Eker Sarıboyacı, AssocProfDr.
role: STUDY_CHAIR
affiliation: Cell Therapy and Stem Cell Production Application and Research Center (ESTEM)
name: Onur Uysal, AssocProfDr.
role: STUDY_DIRECTOR
affiliation: Eskisehir Osmangazi University Faculty of Medicine Department of Orthopedy and Traumatology
name: Ulukan İnan, ProfDr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
citation: Pan H, Zhang P, Zhang Z, Yang Q. Arthroscopic partial meniscectomy combined with medical exercise therapy versus isolated medical exercise therapy for degenerative meniscal tear: A meta-analysis of randomized controlled trials. Int J Surg. 2020 Jul;79:222-232. doi: 10.1016/j.ijsu.2020.05.035. Epub 2020 Jun 6.