A Phase II Trial to Investigate Clinical Efficacy of Autologous Synovial Fluid Mesenchymal Stem Cell-Derived Exosome Application in Patients With Degenerative Meniscal Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of Knee Joint Range of Motion
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: SF-MSC-EX (Drug)
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.
干预措施: SF-MSC (Drug)
结局指标
主要结局
Evaluation of Knee Joint Range of Motion
时间窗: 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
时间窗: 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.
Evaluation of Knee Functions
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Ayla Eker Sariboyaci
Assoc. Prof. Dr.
Eskisehir Osmangazi University