Investigating fetal cell receptors in postpartum women with skin ulcers
"Study of CCR Receptor Overexpression in Fetal Microchimeric Cells: Proof of Concept Before a Potential Clinical Trial"
This study is testing whether fetal cells found in the blood of new mothers with skin ulcers can help heal their wounds better than current treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06031714 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the transcriptomic profile of fetal cells in postpartum women, particularly focusing on the chemokine receptors that are overexpressed in these cells among women with various types of skin ulcers. Researchers will isolate fetal cells from the peripheral blood of both healthy postpartum women and those with skin ulcers, followed by RNA sequencing to identify differences. The study seeks to explore an alternative regenerative medicine strategy that utilizes fetal cells transferred during pregnancy, which may aid in wound healing. By understanding the role of these cells and their receptors, the study hopes to develop new therapeutic approaches for treating skin ulcers.
Who should consider this trial
Good fit: Ideal candidates include adult postpartum women with venous, diabetic, or sickle cell ulcers.
Not a fit: Patients who are minors, immunocompromised, or those who refuse consent or sampling will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to innovative treatments for skin ulcers in postpartum women, enhancing healing and recovery.
How similar studies have performed: While the approach of utilizing fetal cells in regenerative medicine is promising, this specific methodology appears to be novel and untested in the context described.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, Île-de-France Region
- Dermatology unit - Cochin Hospital - APHP — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Sélim ARACTINGI, MD, PHD
- Email: selim.aractingi@aphp.fr
- Phone: 00 33 1 58 41 18 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.