Physiology and Pathologies Linked to Human Splenic Function : Direct and Ex-vivo Perfusion Explorations

NCT ID: NCT06418256

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-16
• Study Completion Date: 2031-10-16

Brief Summary

Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).

Detailed Description

Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).

Participation to the study will be proposed to adult patients in whom a splenic intervention (spleno-pancreatectomy, or a total or partial splenectomy) is planned as part of their treatment.

One or more tubes of venous blood collected for the care will be retrieved following the pre- or intra-operative assessment. These samples will serve as controls during analyzes of splenic filtration mechanisms and/or perfusion experiments with populations of altered or modified cells and/or immunological and/or genetic analyses. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Samples from different experimental conditions (for example red blood cell containing malaria parasite for a culture) may be introduced in the perfusion system pour kinetic analyses. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses by cytology, cytometry, histology, immunohistochemistry, electronic microscopy, biochemistry, molecular biology, single cell analyses, on any other method. Peripheral and splenic blood samples or cells, as well as spleen fragments will be stored in. a biobank for further use or experimental analyses.

Conditions

Splenectomy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Adult patients cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment.

Spleen, blood and plasma collection

Intervention Type: OTHER

Adult patients for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their care. One or more tubes of venous blood collected for the care will be recovered following the pre- or intra-operative assessment. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses.

Interventions

Spleen, blood and plasma collection

Adult patients for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their care. One or more tubes of venous blood collected for the care will be recovered following the pre- or intra-operative assessment. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients
• Patient requiring left splenopancreectomy or planned splenectomy regardless of the method or indication

Exclusion Criteria

• The patient notified his doctor of his refusal to recover his spleen and blood volume

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Buffet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Beaujon

Clichy, , France

Site Status: RECRUITING

Hôpital Saint Antoine

Paris, , France

Site Status: RECRUITING

Hôpital Pitié Salpêtrière

Paris, , France

Site Status: RECRUITING

Hôpital Necker-Enfants Malades

Paris, , France

Site Status: RECRUITING

Institut Pasteur

Paris, , France

Site Status: ACTIVE_NOT_RECRUITING

Countries

France

Central Contacts

Pierre Buffet, MD, PhD

Role: CONTACT

pierre.buffet@aphp.fr

Hélène Morel

Role: CONTACT

helene.morel@aphp.fr

1 71 49 63 46 ext. +33

Facility Contacts

Alain Sauvanet, MD, PhD

Role: primary

alain.sauvanet@aphp.fr

1 40 87 55 84 ext. + 33

Safi Dokmak

Role: backup

safi.dokmak@aphp.fr

1 40 87 57 97 ext. + 33

François Paye, MD, PhD

Role: primary

françois.paye@aphp.fr

1 49 28 25 61 ext. + 33

Christophe Trésallet, MD, PhD

Role: primary

christophe.tresallet@aphp.fr

1 42 17 66 03 ext. + 33

Pierre Buffet, MD, PhD

Role: primary

pierre.buffet@aphp.fr

Other Identifiers

2024-A00654-43

Identifier Type: OTHER

Identifier Source: secondary_id

NI17003

Identifier Type: -

Identifier Source: org_study_id