MEN-ENDO: Menstrual Stem Cells in Endometriosis

Официальное название

Study of the Role of Menstrual Blood-derived Stem Cells and the Immune Environment in Endometriosis

Обзор

Endometriosis is a chronic inflammatory condition characterized by the presence of endometrium-like tissue outside the uterine cavity. It is estimated to affect approximately 10% of women of reproductive age and it is associated with chronic pelvic pain and infertility, among other symptoms. Endometriosis involves complex changes in the body's cells and immune response. For this reason, the goal of this observational study is to characterize the functional, molecular, and immunological alterations in menstrual blood-derived stem cells (MenSCs) and differentiated decidual stromal cells in women with endometriosis; to validate these findings in endometrial tissue and endometriomas; and to establish their correlation with clinical parameters, with the aim of identifying key pathogenic mechanisms and potential therapeutic targets. The main questions it aims to answer are: * Are there functional and molecular changes in MenSCs from patients with endometriosis compared to healthy volunteers? * Are there any variations in the immune properties of MenSCs throughout the menstrual bleeding period in patients with endometriosis compared to healthy volunteers? * Are these changes also present in endometrial tissue and endometrioma samples? * Can these changes be correlated with clinical parameters in patients with endometriosis? * Can MenSCs serve as a potential therapeutic target for endometriosis? Some participants will be asked to provide menstrual blood on a single day, while others will provide samples during the first five days of menstruation. Additionally, all participants will answer questionnaires about their diet, physical activity, stress, and pain levels. Therefore, the study does not involve the evaluation of a specific intervention on the participants. The results will enable the identification of key altered mechanisms and potential therapeutic targets, thereby contributing to the development of more effective strategies for the diagnosis and treatment of the disease.

Вмешательства

• Другое Menstrual blood-derived stem cells collection and in vitro characterization
  Menstrual-blood derived stem cells will be isolated from the menstrual blood of patients with endometriosis and healthy volunteers to be characterized in vitro.

Первичные конечные точки

• MenSCs proliferation rate [Срок оценки: Through study completion (average of 3 years)]
• Phenotypic characterization of MenSCs [Срок оценки: Through study completion (average of 3 years).]
• MenSC chemotaxis [Срок оценки: Through study completion (average of 3 years)]
• MenSC invasion capacity [Срок оценки: Through study completion (average of 3 years)]
• Multilineage capacity of MenSCs [Срок оценки: Through study completion (average of 3 years)]
• Decidualitzation response to progesterone of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers [Срок оценки: Through study completion (average of 3 years).]
• Apoptosis resistance assessment of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers [Срок оценки: Through study completion (average of 3 years).]
• Cytokine profile of the secretome of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells. [Срок оценки: Through study completion (average of 3 years).]
• Cytokine profile of the endometrial and endometrioma tissues [Срок оценки: Through study completion (average of 3 years).]
• Cytokine profile of the secretome of immune cells populations [Срок оценки: Through study completion (average of 3 years)]

Критерии участия

Критерии включения

• 18-45 years.
• Endometriosis group: Women with clinical and/or ecographical diagnostic of endometriosis.
• Control group: Women with the endometriosis diagnosis.

Критерии исключения

• <18 years or >45 years.
• Pregnancy or lactation.
• Diagnosis of prior chronic pelvic inflammatory or autoimmune disease.
• History of active gynecological cancer.
• Positive for human immunodeficiency virus (HIV) or human papillomavirus (HPV).
• Hormonal therapy use in the previous 3 months.
• Use of immunosuppressants or corticosteroids in the previous 3 months.
• Systemic antibiotics use in the previous 3 months.
• Insufficient menstrual flow to allow the MenSCs isolation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 2 центра

• Universitat Rovira i Virgili. Facultat de Medicina i Ciències de la Salut — Reus
• Hospital Universitari Joan XXIII — Tarragona

Идентификаторы

NCT: NCT07578480 · MEN-ENDO CEIm 308/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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