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NCT Number: NCT06031714

Fetal Cell Receptors Repertoire

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology unit - Cochin Hospital - APHP

Paris, Île-de-France Region, 75014, France

Location status: Recruiting

Location contact

Bénédicte OULES, MD

SUB_INVESTIGATOR

Sélim ARACTINGI, MD, PhD

CONTACT

[email protected]

0033 1 58 41 18 13

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Exclusion criteria

  • 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

Treatment and study plan

Saliva sampling

Other

HLA genotyping. The technique should allow to identify, for children's, a paternal HLA antigen not shared with the mothers.

Blood sampling

Other

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.

Interviews

Other

V2 and/or V3

Clinical examination

Other

V2 and/or V3

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Benhammani-Godard

CONTACT

[email protected]

00 33 1 58 41 11 90

Sélim ARACTINGI, MD, PHD

CONTACT

[email protected]

00 33 1 58 41 18 13

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

"Study of CCR Receptor Overexpression in Fetal Microchimeric Cells: Proof of Concept Before a Potential Clinical Trial"

Acronym: MoreCCR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 11, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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