EndometriosisMYODiaphNCT07380308
" Development of Primary Cultures of Diaphragmatic Myoblasts for Basic Research Purposes "
An observational study of Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Neuromuscular diseases (NMDs) affecting motor neurons (MN) induce progressive muscle denervation, and become fatal when respiratory muscles e.g. the diaphragm are affected and can no longer contract. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research.
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 1 May 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diaphragmatic endometriosis requiring surgical nodules resection in the diaphragm.
Who may be able to join
- Age ≥ 18 years
- diaphragmatic endometriosis requiring surgical resection of the nodules in the diaphragm.
- Collection of non-opposition
Who cannot join
- Inability to speak and/or read French
- Patients under tutor or curatorship
- Protected adults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Department of Thoracic Surgery - Cochin Hospital
Paris, IDF, 75014
Marco ALIFANO, MD, PhD, marco.alifano@aphp.fr
Christelle NGUYEN, MD, PhD, 00 33 1 58 41 29 45, christelle.nguyen2@aphp.fr
About this study
Neuromuscular diseases (NMDs) affecting motor neurons (MN) induce progressive muscle denervation, and become fatal when respiratory muscles e.g. the diaphragm are affected and can no longer contract. In some cases, such as Charcot's disease (Amyotrophic lateral sclerosis-ALS), there is no cure and patients die due to respiratory failure few years after diagnosis. Investigations on NMD-induced alterations of respiratory muscles in humans are limited notably by the absence of available in vitro model based on cell cultures of diaphragm-derived myoblasts. Yet, this cell tool is likely to help in developing original therapies to limit diaphragm muscle atrophy and dysfunction in NMD. To date, only cell cultures of human myoblasts obtained from limb muscles are available, making difficult to transpose results to the diaphragm.
Thus, in the present project, we propose to :
Read more
- originally develop primary cultures of myoblasts from human diaphragm, obtained from surgical resection of diaphragmatic endometriosis,
- characterize them in terms of differentiation status (Histology, IF), metabolism (Metabolomics by NMR, cell respiration), and gene expression (RNASeq), in comparison to primary myoblasts cultures derived from the deltoid already available in the team.
This project will provide an original new tool and important data on the specificity of diaphragm-derived myoblasts, compared to limb muscle-derived myoblasts with the long-term perspective of opening new therapeutical pathways for patients with severe NMDs.
Read the detailed description
Neuromuscular diseases (NMDs) affecting motor neurons (MN) induce progressive muscle denervation, and become fatal when respiratory muscles e.g. the diaphragm are affected and can no longer contract. In some cases, such as Charcot's disease (Amyotrophic lateral sclerosis-ALS), there is no cure and patients die due to respiratory failure few years after diagnosis. Investigations on NMD-induced alterations of respiratory muscles in humans are limited notably by the absence of available in vitro model based on cell cultures of diaphragm-derived myoblasts. Yet, this cell tool is likely to help in developing original therapies to limit diaphragm muscle atrophy and dysfunction in NMD. To date, only cell cultures of human myoblasts obtained from limb muscles are available, making difficult to transpose results to the diaphragm.
Thus, in the present project, we propose to :
- originally develop primary cultures of myoblasts from human diaphragm, obtained from surgical resection of diaphragmatic endometriosis,
- characterize them in terms of differentiation status (Histology, IF), metabolism (Metabolomics by NMR, cell respiration), and gene expression (RNASeq), in comparison to primary myoblasts cultures derived from the deltoid already available in the team.
This project will provide an original new tool and important data on the specificity of diaphragm-derived myoblasts, compared to limb muscle-derived myoblasts with the long-term perspective of opening new therapeutical pathways for patients with severe NMDs.
- Conditions
- Endometriosis
- Being tested
- During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research.
- Keywords
- Diaphragmatic endometriosis, Surgical nodules resection
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research.Other
During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with endometriosis requiring surgical nodules resection in the diaphragm. Receives: Other: During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular characteristics
The primary endpoint will be the identification of molecular and cellular signatures specific of the diaphragm as compared with human deltoid muscle cultures, notably based on the study of :
- differentiation, by studying the course of myoblast differentiation and fusion in polynucleated myotubes (IF Desmin, Slow and fast Myosin Heavy Chain),
- energy metabolism (extra- and intra-cellular metabolomics by NMR, cell respiration by the Seahorse technology),
- gene regulation, by analysing the transcriptomic signature (RNAseq).
Measured: Inclusion
Cellular characteristics
The primary endpoint will be the identification of molecular and cellular signatures specific of the diaphragm as compared with human deltoid muscle cultures, notably based on the study of :
- differentiation, by studying the course of myoblast differentiation and fusion in polynucleated myotubes (IF Desmin, Slow and fast Myosin Heavy Chain),
- energy metabolism (extra- and intra-cellular metabolomics by NMR, cell respiration by the Seahorse technology),
- gene regulation, by analysing the transcriptomic signature (RNAseq).
Measured: Inclusion
Secondary outcomes (1)
Presence of diaphragm-derived myoblasts
The secondary endpoint will be to build a library of molecular and cellular signatures for the major respiratory muscle i.e. the diaphragm in human. Decisive differences between cellular and molecular signatures across muscles (Diaphragm and Deltoid) will be analysed by principal component analysis.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, UMR INSERM 1124
- Responsible party
- Sponsor
- Investigators
- Christelle NGUYEN, MD, PHD, Study director, Physical Medicine and Rehabilitation Department - Cochin hospitalMarco ALIFANO, MD, PHD, Principal investigator, Department of Thoracic Surgery - Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380308
- Sponsor's protocol ID
- APHP250977
- Other IDs
- 2024-A02556-41
- Acronym
- MYODiaph
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Development of Primary Cultures of Diaphragmatic Myoblasts for Basic Research Purposes "
- ClinicalTrials.gov ID
- NCT07380308
- Acronym / sponsor ID
- MYODiaph / APHP250977
- Conditions
- Endometriosis
- Keywords
- Diaphragmatic endometriosis, Surgical nodules resection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, UMR INSERM 1124
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 2 Feb 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.
Neuromuscular diseases (NMDs) affecting motor neurons (MN) induce progressive muscle denervation, and become fatal when respiratory muscles e.g. the diaphragm are affected and can no longer contract. In some cases, such as Charcot's disease (Amyotrophic lateral sclerosis-ALS), there is no cure and patients die due to respiratory failure few years after diagnosis. Investigations on NMD-induced alterations of respiratory muscles in humans are limited notably by the absence of available in vitro model based on cell cultures of diaphragm-derived myoblasts. Yet, this cell tool is likely to help in developing original therapies to limit diaphragm muscle atrophy and dysfunction in NMD. To date, only cell cultures of human myoblasts obtained from limb muscles are available, making difficult to transpose results to the diaphragm.
Thus, in the present project, we propose to :
- originally develop primary cultures of myoblasts from human diaphragm, obtained from surgical resection of diaphragmatic endometriosis,
- characterize them in terms of differentiation status (Histology, IF), metabolism (Metabolomics by NMR, cell respiration), and gene expression (RNASeq), in comparison to primary myoblasts cultures derived from the deltoid already available in the team.
This project will provide an original new tool and important data on the specificity of diaphragm-derived myoblasts, compared to limb muscle-derived myoblasts with the long-term perspective of opening new therapeutical pathways for patients with severe NMDs.
Detailed description
Neuromuscular diseases (NMDs) affecting motor neurons (MN) induce progressive muscle denervation, and become fatal when respiratory muscles e.g. the diaphragm are affected and can no longer contract. In some cases, such as Charcot's disease (Amyotrophic lateral sclerosis-ALS), there is no cure and patients die due to respiratory failure few years after diagnosis. Investigations on NMD-induced alterations of respiratory muscles in humans are limited notably by the absence of available in vitro model based on cell cultures of diaphragm-derived myoblasts. Yet, this cell tool is likely to help in developing original therapies to limit diaphragm muscle atrophy and dysfunction in NMD. To date, only cell cultures of human myoblasts obtained from limb muscles are available, making difficult to transpose results to the diaphragm.
Thus, in the present project, we propose to :
- originally develop primary cultures of myoblasts from human diaphragm, obtained from surgical resection of diaphragmatic endometriosis,
- characterize them in terms of differentiation status (Histology, IF), metabolism (Metabolomics by NMR, cell respiration), and gene expression (RNASeq), in comparison to primary myoblasts cultures derived from the deltoid already available in the team.
This project will provide an original new tool and important data on the specificity of diaphragm-derived myoblasts, compared to limb muscle-derived myoblasts with the long-term perspective of opening new therapeutical pathways for patients with severe NMDs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research.Patients with endometriosis requiring surgical nodules resection in the diaphragm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diaphragmatic endometriosis requiring surgical nodules resection in the diaphragm.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- diaphragmatic endometriosis requiring surgical resection of the nodules in the diaphragm.
- Collection of non-opposition
Key exclusion criteria (3 listed)
- Inability to speak and/or read French
- Patients under tutor or curatorship
- Protected adults
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 |
|---|---|---|
| During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research.During the surgery planned as part of the routine care of the patient, a part of the tissue sample will be saved in order to carry out the analysis planned for the research. | Other | Patients |
Primary outcome
Molecular characteristics
Time frame: Inclusion
The primary endpoint will be the identification of molecular and cellular signatures specific of the diaphragm as compared with human deltoid muscle cultures, notably based on the study of : * differentiation, by studying the course of myoblast differentiation and fusion in polynucleated myotubes (IF Desmin, Slow and fast Myosin Heavy Chain), * energy metabolism (extra- and intra-cellular metabolomics by NMR, cell respiration by the Seahorse technology), * gene regulation, by analysing the transcriptomic signature (RNAseq).
Cellular characteristics
Time frame: Inclusion
The primary endpoint will be the identification of molecular and cellular signatures specific of the diaphragm as compared with human deltoid muscle cultures, notably based on the study of : * differentiation, by studying the course of myoblast differentiation and fusion in polynucleated myotubes (IF Desmin, Slow and fast Myosin Heavy Chain), * energy metabolism (extra- and intra-cellular metabolomics by NMR, cell respiration by the Seahorse technology), * gene regulation, by analysing the transcriptomic signature (RNAseq).
1 secondary outcome
Presence of diaphragm-derived myoblasts
Time frame: Inclusion
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 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Christelle NGUYEN, MD, PHD study director
Physical Medicine and Rehabilitation Department - Cochin hospital
Marco ALIFANO, MD, PHD principal investigator
Department of Thoracic Surgery - Cochin Hospital
1 site 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 Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Christelle NGUYEN, MD, PHD (00 33 1 58 41 29 45, christelle.nguyen2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular characteristics (time frame: Inclusion). The study lists 2 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 2 Feb 2026.