Clinical Efficacy of Exosome in Degenerative Meniscal Injury
KNEEXO
A Phase II Trial to Investigate Clinical Efficacy of Autologous Synovial Fluid Mesenchymal Stem Cell-Derived Exosome Application in Patients With Degenerative Meniscal Injury
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 4, 2022
March 1, 2022
2 years
November 1, 2021
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Evaluation of Knee Functions
The functional evaluation of the participants will be evaluated on the Tegner-Lysholm knee scoring scale. In Tegner-Lysholm knee scoring, examinations for the knee joint (Limp, support, pain, instability, locking, swelling, stair-climbing, and squatting) will be evaluated, and a maximum of 100 and a minimum of 0 points will be given. According to the evaluation, \<65 points are interpreted as bad, 65-83 points as fair, 84-90 points as good, \>90 points as excellent. Scores will be recorded by being examined before treatment and at the 6th, and 12th months after treatment. Knee functions of the control group will be evaluated simultaneously, and the effects of treatments on knee function will be determined.
Up to 12th months
Evaluation of Physical Activity
The physical activity evaluation of the participants will be evaluated with the IPAQ (international physical activity questionnaire) short form. IPAQ short form will be evaluated and recorded before treatment and at the 6th, and 12th months after treatment. The control group's physical activity will be evaluated simultaneously, and the effects of treatments on physical activity will be determined.
Up to 12th months
Evaluation of Pain
Pain assessment of the participants will be evaluated with VAS (Visual analog scale). The VAS will be evaluated and recorded before treatment and at the 6th, and 12th months after treatment. The physical activity of the control group will be evaluated simultaneously, and the effects of treatments on pain will be determined.
Up to 12th months
Evaluation of Radiological Images
Participants will receive knee x-ray imaging and knee magnetic resonance imaging before treatment. The same radiological imaging will be performed at the 6th and 12th months after the treatment. At the same time, the same radiological imaging will be performed on the control group, and the effects of treatments on radiological imaging will be evaluated.
Up to 12th months
Evaluation of Cytokine Levels and Cytokine Genes Analyzes
Before treatment and at the 6th and 12th months after treatment, cytokine levels (IL-10, IL-6, TNF-α, IL-8, IL-1β, IFN-ɣ, IL-2, IL-4, IL-13, MCP-1, VEGF) and gene analyzes (IL-10, IL-6, TNF-α, IL-8, IL-1β, IFN-ɣ, IL-2, IL-4, IL-13, MCP-1, IL-1ra, MIP-1b, CTGF, TGFβ3, BMP-2, BMP-4, IGF-1, IGF-2, PDGF, EGF, and VEGF genes) will be checked in the samples taken from the synovial fluid and blood. Samples will be taken from the control group along with the treatment group. In this way, the effects of treatments on cytokine levels will be evaluated.
Up to 12th months
Evaluation of Edema
Edema in both knees will be measured using a tape measure by marking the midpoints of both patellae. Pre-treatment measurements will be recorded. Measurements of both knees will be recorded at 6 months and 12 months after treatment. The knees of the patients not receiving treatment will be measured simultaneously, and the changes will be compared.
Up to 12th months
Evaluation of Knee Joint Range of Motion
The range of motion of both knees will be measured using the "Baseline Digital Absolute+Axis Goniometer." Knee extension measurements will be made with the patient in the supine position and flexion in the prone position. Pre-treatment measurements will be recorded. Post-treatment 6th and 12th-month measurements will also be recorded. Measurements of patients not receiving treatment will be recorded simultaneously, and changes will be compared.
Up to 12th months
Monitoring of treatment-related complications
Adverse effects and complications will be observed in the treatment group, except for the expected local reactions (redness, swelling, bruising, etc.) after the application.
Up to 12th months
Study Arms (3)
SF-MSC-EX Treatment Group (Experimental group's left knees)
EXPERIMENTALThe left knee will receive 1 million cells/kg SF-MSC-EX (Synovial fluid mesenchymal stem cell-derived exosome) by intra-articular injection method.
SF-MSC Treatment Group (Experimental group's right knees)
EXPERIMENTALThe right knee will receive 1 million cells/kg SF-MSC (Synovial fluid-derived mesenchymal stem cell) by intra-articular injection method.
Control Group
NO INTERVENTIONParticipants who received no treatment were defined as the control group.
Interventions
Intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes
Intra-articular administration of synovial fluid-derived mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eskisehir Osmangazi University
Eskişehir, 26040, Turkey (Türkiye)
Related Publications (3)
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
PMID: 4028566BACKGROUNDCraig 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.
PMID: 12900694BACKGROUNDPan 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.
PMID: 32522685BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ayla Eker Sarıboyacı, AssocProfDr.
Cell Therapy and Stem Cell Production Application and Research Center (ESTEM)
- STUDY DIRECTOR
Onur Uysal, AssocProfDr.
Cell Therapy and Stem Cell Production Application and Research Center (ESTEM)
- PRINCIPAL INVESTIGATOR
Ulukan İnan, ProfDr.
Eskisehir Osmangazi University Faculty of Medicine Department of Orthopedy and Traumatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. Dr.
Study Record Dates
First Submitted
November 1, 2021
First Posted
March 2, 2022
Study Start
March 1, 2022
Primary Completion
March 1, 2024
Study Completion
March 1, 2025
Last Updated
March 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Results will be reported after the completion of the study.