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MEN-ENDO: Menstrual Stem Cells in Endometriosis

5. května 2026 aktualizováno: Francisco Algaba Chueca

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

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

40

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Španělsko
    • Tarragona
      • Reus, Tarragona, Španělsko, 43201
        • Aktivní, ne nábor
        • Universitat Rovira i Virgili. Facultat de Medicina i Ciències de la Salut
      • Tarragona, Tarragona, Španělsko, 43005

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Our study population consists of 40 women aged between 18 and 45, 20 of whom have been diagnosed with endometriosis and 20 of whom are healthy volunteers. Participants will be recruited from the Department of Gynecology and Obstetrics at the Hospital Universitari Joan XXIII in Tarragona (Spain) during routine gynecological check-ups. Healthy volunteers will be selected through individual matching with participants in the study group, considering relevant demographic and clinical variables such as age and ethnic group.

In addition, a sub-cohort of 10 women (5 per study group) will be selected from the main cohort to study in greater detail the intra-menstrual variations in the immunomodulatory properties of MenSCs. This sub-cohort will include participants who agree to provide menstrual blood samples from days 1 to 5 (both inclusive) to analyze dynamic changes in the cells obtained, while maintaining the same general inclusion and exclusion criteria as in the main study.

Popis

Inclusion Criteria:

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

Exclusion Criteria:

  • <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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Endometriosis
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
MenSCs proliferation rate
Časové okno: Through study completion (average of 3 years)
Evaluation of the expansion capacity of MenSCs from endometriosis patients vs. healthy controls using the MTT assay.
Through study completion (average of 3 years)
Phenotypic characterization of MenSCs
Časové okno: Through study completion (average of 3 years).
Evaluation of surface marker expression using flow cytometry to determine the phenotype of MenSCs from endometriosis patients and healthy controls.
Through study completion (average of 3 years).
MenSC chemotaxis
Časové okno: Through study completion (average of 3 years)
Assessment of the number of T-lymphocytes and monocytes capable of migrating through a transwell membrane under the stimuli of conditioned media from MenSCs obtained from endometriosis patients and healthy controls.
Through study completion (average of 3 years)
MenSC invasion capacity
Časové okno: Through study completion (average of 3 years)
Assessment of the number of MenSCs from endometriosis patients vs. healthy controls capable of degrading a Matrigel on a transwell membrane and migrating toward a chemoattractant.
Through study completion (average of 3 years)
Multilineage capacity of MenSCs
Časové okno: Through study completion (average of 3 years)
The differentiation potential of MenSCs from endometriosis patients vs. healthy controls towards osteocytes, chondrocytes and adipocytes will be assessed by using specific media.
Through study completion (average of 3 years)
Decidualitzation response to progesterone of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers
Časové okno: Through study completion (average of 3 years).
MenSCs will be cultured in presence of 8-Br-cAMP during 14 days, and the assessment of morphology and expression of decidual markers will be performed by RT-qPCR and ELISA assay.
Through study completion (average of 3 years).
Apoptosis resistance assessment of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers
Časové okno: Through study completion (average of 3 years).
Apoptosis resistance will be evaluated by Annexin V/PI flow cytometry following induction by TNFα. Additionally, the expression of key apoptotic mediators will be quantified using RT-qPCR and Western blot.
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.
Časové okno: Through study completion (average of 3 years).
The conditioned media will be assessed to determine the cytokines secreted using an ELISA assay.
Through study completion (average of 3 years).
Cytokine profile of the endometrial and endometrioma tissues
Časové okno: Through study completion (average of 3 years).
The levels of cytokines in the conditioned media from cultured explants will be assessed by ELISA assay.
Through study completion (average of 3 years).
Cytokine profile of the secretome of immune cells populations
Časové okno: Through study completion (average of 3 years)
The levels of cytokines in the conditioned media from lymphocytes and macrophages will be assessed by ELISA assay.
Through study completion (average of 3 years)
Cytokine profile of the peripheral blood plasma
Časové okno: Through study completion (average of 3 years)
The levels of cytokines in peripheral blood plasma from endometriosis patients and healthy volunteers will be determined by ELISA assay.
Through study completion (average of 3 years)
Gene expression profile of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells
Časové okno: Through study completion (average of 3 years)
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Through study completion (average of 3 years)
Gene expression profile of the endometrial and endometrioma tissues
Časové okno: Through study completion (average of 3 years).
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Through study completion (average of 3 years).
Gene expression profile of the immune cells populations
Časové okno: Through study completion (average of 3 years)
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Through study completion (average of 3 years)
Protein expression of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells
Časové okno: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Through study completion (average of 3 years)
Protein expression in endometrial and endometrioma tissues
Časové okno: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Through study completion (average of 3 years)
Protein expression in immune cells populations
Časové okno: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Through study completion (average of 3 years)
T cells activation
Časové okno: Through study completion (average of 3 years)
T cells will be exposed to conditioned media from MenSCs from healthy volunteers and endometriosis patients. Afterwards, the levels of IL-10 and IFNy will be determined by ELISA assay.
Through study completion (average of 3 years)
T cells proliferation rate
Časové okno: Through study completion (average of 3 years)
T cells will be exposed to conditioned media from MenSCs from healthy volunteers and endometriosis patients. Afterwards, their proliferative capacity will be assessed by MTT assay.
Through study completion (average of 3 years)
Cytokine secretion profile of macrophages
Časové okno: Through study completion (average of 3 years)
The levels of cytokines in the supernatant of polarized macrophages after incubation with MenSC-derived conditioned media from endometriosis patients and healthy volunteers will be determined by ELISA assay.
Through study completion (average of 3 years)
Gene expression profile of macrophages
Časové okno: Through study completion (average of 3 years)
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Through study completion (average of 3 years)
Protein expression of macrophages
Časové okno: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Through study completion (average of 3 years)
Phagocytic capacity of macrophages
Časové okno: Through study completion (average of 3 years)
Assessment of the macrophages' ability to engulf fluorescently labeled apoptotic bodies from MenSCs via flux cytometry and fluorescence microscopy.
Through study completion (average of 3 years)
Angiogenic potential of macrophages conditioned media
Časové okno: Through study completion (average of 3 years)
Evaluation of the ability of macrophage-derived conditioned media to induce tube formation (Matrigel) in Human Umbilical Vein Endothelial Cells (HUVECs).
Through study completion (average of 3 years)
Exploration of targeted interventions to reverse the pathological phenotype of MenSCs and macrophages derived from menstrual blood.
Časové okno: Through study completion (average of 3 years).
Signaling pathways and genes involved in the altered phenotype will be blocked and silenced, respectively, to evaluate if these actions reverse the cellular response to the levels of the healthy volunteers' cells.
Through study completion (average of 3 years).
Correlation of cellular, tissue and molecular findings with patients' clinical parameters.
Časové okno: Through study completion (average of 3 years).
The associations among the functional and immunological properties of MenSCs and macrophages, clinical parameters and dietary and behavioral habits will be stablished. These clinical parameters include endometriosis stage, pain and fertility status, and the extent and localization of the endometriosis foci.
Through study completion (average of 3 years).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Francisco Algaba Chueca

Spolupracovníci

Hospital Universitari Joan XXIII de Tarragona.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. dubna 2026

Primární dokončení (Odhadovaný)

1. října 2027

Dokončení studie (Odhadovaný)

1. dubna 2028

Termíny zápisu do studia

První předloženo

13. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

5. května 2026

První zveřejněno (Aktuální)

11. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MEN-ENDO CEIm 308/2025

Informace o lécích a zařízeních, studijní dokumenty

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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