Clinical Efficacy of Exosome in Degenerative Meniscal Injury (KNEEXO)
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|ClinicalTrials.gov Identifier: NCT05261360|
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : March 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Knee; Injury, Meniscus (Lateral) (Medial) Meniscus Tear Meniscus Lesion Meniscus; Degeneration Meniscus; Laceration Meniscus Injury, Tibial Knee Injuries Knee Pain Swelling Arthralgia||Drug: SF-MSC-EX Drug: SF-MSC||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||March 2022|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2025|
Experimental: SF-MSC-EX Treatment Group (Experimental group's left knees)
The left knee will receive 1 million cells/kg SF-MSC-EX (Synovial fluid mesenchymal stem cell-derived exosome) by intra-articular injection method.
Intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes
Other Name: Intraarticular Exosome Treatment
Experimental: SF-MSC Treatment Group (Experimental group's right knees)
The right knee will receive 1 million cells/kg SF-MSC (Synovial fluid-derived mesenchymal stem cell) by intra-articular injection method.
Intra-articular administration of synovial fluid-derived mesenchymal stem cells
Other Name: Intraarticular Stem Cell Treatment
No Intervention: Control Group
Participants who received no treatment were defined as the control group.
- Evaluation of Knee Functions [ Time Frame: Up to 12th months ]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.
- Evaluation of Physical Activity [ Time Frame: Up to 12th months ]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.
- Evaluation of Pain [ Time Frame: Up to 12th months ]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.
- Evaluation of Radiological Images [ Time Frame: Up to 12th months ]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.
- Evaluation of Cytokine Levels and Cytokine Genes Analyzes [ Time Frame: Up to 12th months ]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.
- Evaluation of Edema [ Time Frame: Up to 12th months ]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.
- Evaluation of Knee Joint Range of Motion [ Time Frame: Up to 12th months ]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.
- Monitoring of treatment-related complications [ Time Frame: Up to 12th months ]Adverse effects and complications will be observed in the treatment group, except for the expected local reactions (redness, swelling, bruising, etc.) after the application.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05261360
|Contact: Ayla Eker Sarıboyacı, AssocProfDr.||+firstname.lastname@example.org|
|Eskisehir Osmangazi University||Recruiting|
|Eskisehir, Turkey, 26040|
|Contact: Ayla Eker Sariboyaci, AssocProfDr +905382696420 email@example.com|
|Principal Investigator: Ulukan Inan, Prof.Dr.|
|Sub-Investigator: Ayla Eker Sariboyaci, AssocProfDr|
|Sub-Investigator: Onur Uysal, AssocProfDr|
|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|