Venous UlcerMoreCCRNCT06031714
Fetal Cell Receptors Repertoire
A study testing Saliva sampling, Blood sampling and Interviews in people with Venous Ulcer and Sickle Cell Ulcer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to describe the transcriptomic profile of foetal cells in post-partum and more specifically to determine which chemokine receptors are overexpressed in foetal cells in post-partum women with wounds To do so, the investigators will isolate foetal cells from the peripheral blood of healthy… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcer, Sickle Cell Ulcer, Diabetic Ulcer
- What is being tested?
- Saliva sampling, Blood sampling and Interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2024to 1 Feb 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Common criteria :
- Adult women,
- Post-partum: having been pregnant for any length of time,
- Having signed a free and informed consent form,
- Primiparous or multiparous,
- Affiliated to a health insurance
Show all 13Show fewer
- Patients :
- Patients with a venous, diabetic or sickle cell ulcer, or mixed ulcer
- Control group patients :
- Volunteers,
- Age-matched,
- Without skin ulcers.
- There are no specific criteria for children.
Who cannot join
- Minors (for patients)
- Under court protection, curatorship, guardianship (for patients)
- Immunocompromised patients for any reason whatsoever
- Refusal of consent
- Refusal of blood and/or saliva samples for themselves or a member of their family
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, 1 recruiting
- Recruiting
Dermatology unit - Cochin Hospital - APHP
Paris, Île-de-France Region, 75014
Sélim ARACTINGI, MD, PhD, 0033 1 58 41 18 13, selim.aractingi@aphp.fr
Bénédicte OULES, MD
About this study
Official title: "Study of CCR Receptor Overexpression in Fetal Microchimeric Cells: Proof of Concept Before a Potential Clinical Trial"
The purpose of this study is to describe the transcriptomic profile of foetal cells in post-partum and more specifically to determine which chemokine receptors are overexpressed in foetal cells in post-partum women with wounds To do so, the investigators will isolate foetal cells from the peripheral blood of healthy controls post partum women as well as from post partum women with skin ulcers and then perform RNA sequencing.
Read the detailed description
The aim of regenerative medicine is to repair damaged tissue using different sources of autologous or heterologous stem cells. These cells are then cultured to achieve amplification and differentiation adapted to the cell type of the organ to be repaired. These methods are potentially effective, but involve risks and limitations, in particular the risks of genetic modifications during culture or contamination by residual ES or iPS cells. Immunosuppressive treatment is also necessary if the source of stem cells is allogeneic. Finally, implantation of this type of culture may also be unsuccessful.
Our team is seeking for an alternative strategy to these methods. This relies on the presence of a niche of foetal cells transferred during pregnancy that persist after delivery. In fact, all mammalian pregnancies lead to foetal-maternal cell transfer. The foetal cells -transferred to the maternal circulation- contain different types of stem cells that will remain in the maternal bone marrow and persist there for the rest of the mother's life. The team has shown that in the event of cutaneous wounds in post-gestational mice, a population of CD11b+ CD34+ CD31+ foetal progenitors was recruited from the maternal bone marrow to the cutaneous granulation tissue. These cells over-express the chemokine receptor CCR2 compared with their adult counterparts. Consequently, the injection of low, so-called physiological, doses of the CCL2 chemokine subcutaneously into wounds accelerates normal wound healing and restores delayed healing in two pathological models. This pro-healing activity is linked to the specific recruitment of foetal stem cells to the site of injected wounds. These low doses of CCL2 never affected wound healing in virgin mice, confirming that this type of treatment does not alter the homeostasis of adult cells.
The therapeutic strategy the investigators are proposing, entitled "natural stem therapy", is based on this reservoir of foetal stem cells present in every woman who has had at least one pregnancy, i.e. more than 60% of adult women in western countries. In order to test the validity of this concept, it is important to ascertain the pathways by which foetal cells are chemoattracted in the human species, in particular the CCR2/CCL2 pathway.
- Conditions
- Venous Ulcer, Sickle Cell Ulcer, Diabetic Ulcer, Post-partum Women, Mixed Ulcer
- Being tested
- Saliva sampling, Blood sampling, Interviews, Clinical examination
- Keywords
- Microchimerism, Foetal stem cells, Receptors
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva samplingOther
HLA genotyping. The technique should allow to identify, for children's, a paternal HLA antigen not shared with the mothers.
Blood samplingOther
Maternal Blood samples will be incubated with the appropriate antibody, targeting the microchimeric fetal cells of each patient, as well as with a cell viability marker (DAPI). The samples were then be processed through the BD FACS Aria III to sort the fetal cells,
The following steps - RNA extraction, quality control, retrotranscription, preparation of the library, sequencing and transcriptomic analysis - will be carried out according to the Smart-seq3 protocol. The data will be sent for in-depth analysis and confirmation of the results. Additional functional experiments may also be carried out.
InterviewsOther
V2 and/or V3
Clinical examinationOther
V2 and/or V3
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Patients who have had at least one pregnancy and have a venous ulcer, diabetic ulcer or sickle cell ulcer Receives: Other: Saliva sampling; Other: Blood sampling; Other: Interviews; Other: Clinical examination |
| Patient "Controls group " | Other | Post-partum women of the same age but without wounds. Receives: Other: Saliva sampling; Other: Blood sampling; Other: Interviews; Other: Clinical examination |
| Children | Other | Not described Receives: Other: Saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic analysis by single cell sequencing
Transcriptomic analysis by single cell RNA sequencing (Smart-seq3 protocol) of fetal cells sorted from peripheral blood
Measured: Month 1 up to month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start6 Feb 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 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
- Responsible party
- Sponsor
- Investigators
- Sélim ARACTINGI, MD, PHD, Study director, Dermatology unit, Cochin Hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031714
- Sponsor's protocol ID
- APHP230731
- Other IDs
- 2023-A00404-41
- Acronym
- MoreCCR
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2023
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Study of CCR Receptor Overexpression in Fetal Microchimeric Cells: Proof of Concept Before a Potential Clinical Trial"
- ClinicalTrials.gov ID
- NCT06031714
- Acronym / sponsor ID
- MoreCCR / APHP230731
- Conditions
- Venous Ulcer, Sickle Cell Ulcer, Diabetic Ulcer, Post-partum Women, Mixed Ulcer
- Keywords
- Microchimerism, Foetal stem cells, Receptors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 11 Sep 2023 (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.
The purpose of this study is to describe the transcriptomic profile of foetal cells in post-partum and more specifically to determine which chemokine receptors are overexpressed in foetal cells in post-partum women with wounds To do so, the investigators will isolate foetal cells from the peripheral blood of healthy controls post partum women as well as from post partum women with skin ulcers and then perform RNA sequencing.
Detailed description
The aim of regenerative medicine is to repair damaged tissue using different sources of autologous or heterologous stem cells. These cells are then cultured to achieve amplification and differentiation adapted to the cell type of the organ to be repaired. These methods are potentially effective, but involve risks and limitations, in particular the risks of genetic modifications during culture or contamination by residual ES or iPS cells. Immunosuppressive treatment is also necessary if the source of stem cells is allogeneic. Finally, implantation of this type of culture may also be unsuccessful.
Our team is seeking for an alternative strategy to these methods. This relies on the presence of a niche of foetal cells transferred during pregnancy that persist after delivery. In fact, all mammalian pregnancies lead to foetal-maternal cell transfer. The foetal cells -transferred to the maternal circulation- contain different types of stem cells that will remain in the maternal bone marrow and persist there for the rest of the mother's life. The team has shown that in the event of cutaneous wounds in post-gestational mice, a population of CD11b+ CD34+ CD31+ foetal progenitors was recruited from the maternal bone marrow to the cutaneous granulation tissue. These cells over-express the chemokine receptor CCR2 compared with their adult counterparts. Consequently, the injection of low, so-called physiological, doses of the CCL2 chemokine subcutaneously into wounds accelerates normal wound healing and restores delayed healing in two pathological models. This pro-healing activity is linked to the specific recruitment of foetal stem cells to the site of injected wounds. These low doses of CCL2 never affected wound healing in virgin mice, confirming that this type of treatment does not alter the homeostasis of adult cells.
The therapeutic strategy the investigators are proposing, entitled "natural stem therapy", is based on this reservoir of foetal stem cells present in every woman who has had at least one pregnancy, i.e. more than 60% of adult women in western countries. In order to test the validity of this concept, it is important to ascertain the pathways by which foetal cells are chemoattracted in the human species, in particular the CCR2/CCL2 pathway.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Saliva sampling, Other: Blood sampling, Other: Interviews, Other: Clinical examinationPatients who have had at least one pregnancy and have a venous ulcer, diabetic ulcer or sickle cell ulcer |
| Patient "Controls group " | Other | Other: Saliva sampling, Other: Blood sampling, Other: Interviews, Other: Clinical examinationPost-partum women of the same age but without wounds. |
| Children | Other | Other: Saliva sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Adult women,
- Post-partum: having been pregnant for any length of time,
- Having signed a free and informed consent form,
- Primiparous or multiparous,
- Affiliated to a health insurance
Key exclusion criteria (5 listed)
- Minors (for patients)
- Under court protection, curatorship, guardianship (for patients)
- Immunocompromised patients for any reason whatsoever
- Refusal of consent
- Refusal of blood and/or saliva samples for themselves or a member of their family
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 |
|---|---|---|
| Saliva samplingHLA genotyping. The technique should allow to identify, for children's, a paternal HLA antigen not shared with the mothers. | Other | Children, Patient "Controls group ", Patients |
| Blood samplingMaternal Blood samples will be incubated with the appropriate antibody, targeting the microchimeric fetal cells of each patient, as well as with a cell viability marker (DAPI). The samples were then be processed through the BD FACS Aria III to sort the fetal cells, The following steps - RNA extraction, quality control, retrotranscription, preparation of the library, sequencing and transcriptomic analysis - will be carried out according to the Smart-seq3 protocol. The data will be sent for in-depth analysis and confirmation of the results. Additional functional experiments may also be carried out. | Other | Patient "Controls group ", Patients |
| InterviewsV2 and/or V3 | Other | Patient "Controls group ", Patients |
| Clinical examinationV2 and/or V3 | Other | Patient "Controls group ", Patients |
Primary outcome
Transcriptomic analysis by single cell sequencing
Time frame: Month 1 up to month 5
Transcriptomic analysis by single cell RNA sequencing (Smart-seq3 protocol) of fetal cells sorted from peripheral blood
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 12 Sep 2025.
- 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.
Sélim ARACTINGI, MD, PHD study director
Dermatology unit, Cochin Hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva sampling, Blood sampling and Interviews in people with Venous Ulcer and Sickle Cell Ulcer, 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 13 inclusion and 5 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 12 Sep 2025. 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 Sélim ARACTINGI, MD, PHD (00 33 1 58 41 18 13, selim.aractingi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic analysis by single cell sequencing (time frame: Month 1 up to month 5). 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 12 Sep 2025.