EndometriosisNCT07578480
MEN-ENDO: Menstrual Stem Cells in Endometriosis
An observational study of Endometriosis, run by Francisco Algaba Chueca at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Menstrual blood-derived stem cells collection and in vitro characterization
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study 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.
Who may be able to join
- 18-45 years.
- Endometriosis group: Women with clinical and/or ecographical diagnostic of endometriosis.
- Control group: Women with the endometriosis diagnosis.
Who cannot join
- <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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 1 recruiting
- Active, not recruiting
Universitat Rovira i Virgili. Facultat de Medicina i Ciències de la Salut
Reus, Tarragona, 43201
- Recruiting
Hospital Universitari Joan XXIII
Tarragona, Tarragona, 43005
Dr. Joana Galera Ortega, +34977295800, jgalera.hj23.ics@gencat.cat
Dr. Albert Guarque Rus, +34977295835, aguarque.hj23.ics@gencat.cat
About this study
Official title: 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.
Read more
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.
- Conditions
- Endometriosis
- Being tested
- Menstrual blood-derived stem cells collection and in vitro characterization
- Keywords
- Menstrual blood-derived stem cells, Menstrual blood
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual blood-derived stem cells collection and in vitro characterizationOther
Menstrual-blood derived stem cells will be isolated from the menstrual blood of patients with endometriosis and healthy volunteers to be characterized in vitro.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Not described Receives: Other: Menstrual blood-derived stem cells collection and in vitro characterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
MenSCs proliferation rate
Evaluation of the expansion capacity of MenSCs from endometriosis patients vs. healthy controls using the MTT assay.
Measured: Through study completion (average of 3 years)
Phenotypic characterization of MenSCs
Evaluation of surface marker expression using flow cytometry to determine the phenotype of MenSCs from endometriosis patients and healthy controls.
Measured: Through study completion (average of 3 years).
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.
Measured: Through study completion (average of 3 years)
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.
Measured: Through study completion (average of 3 years)
Multilineage capacity of MenSCs
The differentiation potential of MenSCs from endometriosis patients vs. healthy controls towards osteocytes, chondrocytes and adipocytes will be assessed by using specific media.
Measured: Through study completion (average of 3 years)
Decidualitzation response to progesterone of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers
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.
Measured: Through study completion (average of 3 years).
Apoptosis resistance assessment of the decidual cells differentiated from MenSCs from endometriosis patients and healthy volunteers
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.
Measured: 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.
The conditioned media will be assessed to determine the cytokines secreted using an ELISA assay.
Measured: Through study completion (average of 3 years).
Cytokine profile of the endometrial and endometrioma tissues
The levels of cytokines in the conditioned media from cultured explants will be assessed by ELISA assay.
Measured: Through study completion (average of 3 years).
Cytokine profile of the secretome of immune cells populations
The levels of cytokines in the conditioned media from lymphocytes and macrophages will be assessed by ELISA assay.
Measured: Through study completion (average of 3 years)
Cytokine profile of the peripheral blood plasma
The levels of cytokines in peripheral blood plasma from endometriosis patients and healthy volunteers will be determined by ELISA assay.
Measured: Through study completion (average of 3 years)
Gene expression profile of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Measured: Through study completion (average of 3 years)
Gene expression profile of the endometrial and endometrioma tissues
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Measured: Through study completion (average of 3 years).
Gene expression profile of the immune cells populations
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Measured: Through study completion (average of 3 years)
Protein expression of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells
Analysis of the protein expression profile via Western Blot.
Measured: Through study completion (average of 3 years)
Protein expression in endometrial and endometrioma tissues
Analysis of the protein expression profile via Western Blot.
Measured: Through study completion (average of 3 years)
Protein expression in immune cells populations
Analysis of the protein expression profile via Western Blot.
Measured: Through study completion (average of 3 years)
T cells activation
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.
Measured: Through study completion (average of 3 years)
T cells proliferation rate
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.
Measured: Through study completion (average of 3 years)
Cytokine secretion profile of macrophages
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.
Measured: Through study completion (average of 3 years)
Gene expression profile of macrophages
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Measured: Through study completion (average of 3 years)
Protein expression of macrophages
Analysis of the protein expression profile via Western Blot.
Measured: Through study completion (average of 3 years)
Phagocytic capacity of macrophages
Assessment of the macrophages' ability to engulf fluorescently labeled apoptotic bodies from MenSCs via flux cytometry and fluorescence microscopy.
Measured: Through study completion (average of 3 years)
Angiogenic potential of macrophages conditioned media
Evaluation of the ability of macrophage-derived conditioned media to induce tube formation (Matrigel) in Human Umbilical Vein Endothelial Cells (HUVECs).
Measured: Through study completion (average of 3 years)
Exploration of targeted interventions to reverse the pathological phenotype of MenSCs and macrophages derived from menstrual blood.
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.
Measured: Through study completion (average of 3 years).
Correlation of cellular, tissue and molecular findings with patients' clinical parameters.
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.
Measured: Through study completion (average of 3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Algaba Chueca
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Sponsor-investigator, Francisco Algaba Chueca, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578480
- Sponsor's protocol ID
- MEN-ENDO CEIm 308/2025
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Menstrual Blood-derived Stem Cells and the Immune Environment in Endometriosis
- ClinicalTrials.gov ID
- NCT07578480
- Acronym / sponsor ID
- MEN-ENDO CEIm 308/2025
- Conditions
- Endometriosis
- Keywords
- Menstrual blood-derived stem cells, Menstrual blood
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Francisco Algaba ChuecaUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Other: Menstrual blood-derived stem cells collection and in vitro characterization |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (3 listed)
- 18-45 years.
- Endometriosis group: Women with clinical and/or ecographical diagnostic of endometriosis.
- Control group: Women with the endometriosis diagnosis.
Key exclusion criteria (9 listed)
- <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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual blood-derived stem cells collection and in vitro characterizationMenstrual-blood derived stem cells will be isolated from the menstrual blood of patients with endometriosis and healthy volunteers to be characterized in vitro. | Other | Endometriosis |
Primary outcome
MenSCs proliferation rate
Time frame: Through study completion (average of 3 years)
Evaluation of the expansion capacity of MenSCs from endometriosis patients vs. healthy controls using the MTT assay.
Phenotypic characterization of MenSCs
Time frame: 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.
MenSC chemotaxis
Time frame: 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.
MenSC invasion capacity
Time frame: 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.
Multilineage capacity of MenSCs
Time frame: 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.
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).
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.
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).
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.
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).
The conditioned media will be assessed to determine the cytokines secreted using an ELISA assay.
Cytokine profile of the endometrial and endometrioma tissues
Time frame: Through study completion (average of 3 years).
The levels of cytokines in the conditioned media from cultured explants will be assessed by ELISA assay.
Cytokine profile of the secretome of immune cells populations
Time frame: 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.
Cytokine profile of the peripheral blood plasma
Time frame: 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.
Gene expression profile of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells
Time frame: Through study completion (average of 3 years)
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Gene expression profile of the endometrial and endometrioma tissues
Time frame: Through study completion (average of 3 years).
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Gene expression profile of the immune cells populations
Time frame: Through study completion (average of 3 years)
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Protein expression of MenSCs from endometriosis patients and healthy volunteers and their differentiated decidual cells
Time frame: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Protein expression in endometrial and endometrioma tissues
Time frame: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Protein expression in immune cells populations
Time frame: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
T cells activation
Time frame: 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.
T cells proliferation rate
Time frame: 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.
Cytokine secretion profile of macrophages
Time frame: 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.
Gene expression profile of macrophages
Time frame: Through study completion (average of 3 years)
Total RNA expression of targeted genes will be analyzed by RT-qPCR.
Protein expression of macrophages
Time frame: Through study completion (average of 3 years)
Analysis of the protein expression profile via Western Blot.
Phagocytic capacity of macrophages
Time frame: 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.
Angiogenic potential of macrophages conditioned media
Time frame: 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).
Exploration of targeted interventions to reverse the pathological phenotype of MenSCs and macrophages derived from menstrual blood.
Time frame: 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.
Correlation of cellular, tissue and molecular findings with patients' clinical parameters.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Francisco Algaba Chueca at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Francisco Algaba-Chueca (+34623966066, francisco.algaba@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MenSCs proliferation rate (time frame: Through study completion (average of 3 years)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.