MEN-ENDO: Menstrual Stem Cells in Endometriosis
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorFrancisco Algaba Chueca
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-45 years.
Endometriosis group: Women with clinical and/or ecographical diagnostic of endometriosis.
Control group: Women with the endometriosis diagnosis.
Disqualifiers
<18 years or >45 years.
Pregnancy or lactation.
Diagnosis of prior chronic pelvic inflammatory or autoimmune disease.
History of active gynecological cancer.
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Menstrual blood-derived stem cells collection and in vitro characterization
Other interventionMenstrual-blood derived stem cells will be isolated from the menstrual blood of patients with endometriosis and healthy volunteers to be characterized in vitro.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Endometriosis1 intervention
Trial outcomes
Primary outcomes
1
MenSCs proliferation rate
Evaluation of the expansion capacity of MenSCs from endometriosis patients vs. healthy controls using the MTT assay.
Time frame
Through study completion (average of 3 years)2
Phenotypic characterization of MenSCs
Evaluation of surface marker expression using flow cytometry to determine the phenotype of MenSCs from endometriosis patients and healthy controls.
Time frame
Through study completion (average of 3 years).3
MenSC chemotaxis
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.
Time frame
Through study completion (average of 3 years)4
MenSC invasion capacity
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.
Time frame
Through study completion (average of 3 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Francisco Algaba Chueca
Lead sponsor
University Rovira i Virgili
Sponsor institution
Hospital Universitari Joan XXIII de Tarragona.
Collaborator
Source ClinicalTrials.gov