MEN-ENDO: Menstrual Stem Cells in Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Menstrual blood-derived stem cells collection and in vitro characterization.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of the Role of Menstrual Blood-derived Stem Cells and the Immune Environment in Endometriosis
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- MenSCs proliferation rate [Time frame: Through study completion (average of 3 years)]
- Phenotypic characterization of MenSCs [Time frame: Through study completion (average of 3 years).]
- MenSC chemotaxis [Time frame: Through study completion (average of 3 years)]
- MenSC invasion capacity [Time frame: Through study completion (average of 3 years)]
- Multilineage capacity of MenSCs [Time frame: Through study completion (average of 3 years)]
- Decidualitzation response to progesterone of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers [Time frame: Through study completion (average of 3 years).]
- Apoptosis resistance assessment of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers [Time frame: 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. [Time frame: Through study completion (average of 3 years).]
- Cytokine profile of the endometrial and endometrioma tissues [Time frame: Through study completion (average of 3 years).]
- Cytokine profile of the secretome of immune cells populations [Time frame: Through study completion (average of 3 years)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 2 centers
- Universitat Rovira i Virgili. Facultat de Medicina i Ciències de la Salut — Reus
- Hospital Universitari Joan XXIII — Tarragona
Identifiers
NCT: NCT07578480 · MEN-ENDO CEIm 308/2025