跳至主要内容
临床试验/NCT07511959
NCT07511959Enrolling By Invitation不适用

Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Medicine - Assessment of Content and Therapeutic Potential in the Process of Temporomandibular Joint Regeneration

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
68
试验地点
1
主要终点
Comparison of the impact of exosomes, PRF and PRP (from the study and control groups) on the proliferation and migration of human chondrocytes and fibroblasts

研究概览

简要总结

The aim of the research is the laboratory assessment of the content as well as the regenerative and anti-inflammatory potential of autologous exosomes (EXO) from platelet-rich plasma (PRP), as well as their comparison with other autologous products used in intra-articular injections, namely platelet-rich plasma and platelet-rich fibrin (PRF).

The material for the research will be obtained from patients of the Temporomandibular Joint Dysfunction Clinic at the University Dental Center in Wrocław with chronic pain of the temporomandibular joints (TMJ) and/or masticatory muscles and/or chronic disturbances in temporomandibular joint mobility, as well as from healthy individuals.

In the subsequent stages, the biological material will be analyzed under laboratory conditions to compare the composition and biological properties of PRP, PRF and EXO.

详细描述

The research focuses on the laboratory assessment of the content and the regenerative and anti-inflammatory potential of autologous exosomes from platelet-rich plasma, as well as their comparison with other autologous products used in intra-articular injections (PRP, PRF).

The work will include:

  1. Production of autologous materials (PRP, PRF, EXO); appropriate centrifuges and the AutologIX system (Biological Innovations) will be used for isolation.
  2. Characterization of physico-chemical properties of EXO (concentration, size, morphology), using analytical methods such as nanoparticle tracking analysis (NTA) and transmission electron microscopy (TEM).
  3. Analysis of content using flow cytometry and spectrophotometry.
  4. Assessment of uptake by cells (using confocal microscopy) and promotion of proliferation and migration of human chondrocytes and fibroblasts.
  5. Comparative analysis of the results obtained (1) for the study and control groups and (2) for PRP, PRF, and EXO.

The implementation of the project will constitute a significant contribution to the development of knowledge about the molecular mechanisms of the regenerative action of plasma-derived exosomes. The obtained results will allow a better understanding of the action of the evaluated systems, and, consequently, better effects of intra-articular injections through the optimal selection of autologous injection material. It should be emphasized that autologous injection therapies are safe for patients and are associated with the lowest risk of complications among all injection therapies used in the treatment of TMJ disorders, which is why their precise investigation is very important.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic pain of the temporomandibular joints and/or masticatory muscles and/or chronic dysfunction of the temporomandibular joints (lasting more than 3 months, diagnosed based on the standardized, international Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol) - criterion for the study group
  • consent to participate in the study - criterion for both groups
  • age over 18 years - criterion for both groups

排除标准

  • pregnancy
  • uncontrolled diabetes
  • cardiovascular diseases (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, sepsis, hemoglobin < 10 g/dl, platelet count < 105/µl)
  • severe autoimmune diseases
  • taking anticoagulants
  • active skin lesions at the planned puncture site
  • infections, patient undergoing antibiotic therapy, or within 3 weeks of its completion.

研究组 & 干预措施

Study group

Patients with chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders

干预措施: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples (Diagnostic Test)

Control group

Healthy participants without a diagnosis of chronic temporomandibular joint pain and/or masticatory muscle pain and/or chronic temporomandibular joint movement disorders

干预措施: Laboratory analysis of the content and biological activity of PRP, PRF, and exosomes obtained from blood samples (Diagnostic Test)

结局指标

主要结局

Comparison of the impact of exosomes, PRF and PRP (from the study and control groups) on the proliferation and migration of human chondrocytes and fibroblasts

时间窗: 04.2026 - 12.2027

Comparison of the number and size of exosomes obtained from the study and control groups

时间窗: 04.2026 - 12.2027

Comparison of the level of cytokines and growth factors in exosomes, PRF and PRP samples obtained from the study and control groups

时间窗: 04.2026 - 12.2027

次要结局

未报告次要终点

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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