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

ConditionSplenectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients

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

Disqualifiers

None

Trial population

Adult patients with no age limit 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Spleen, blood and plasma collection

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells

Ability of the isolated-perfused human spleen to filter altered cell populations.

Time frame
Day 0

Secondary outcomes

1

Exploring splenic immunological mechanisms

Explore splenic immunological mechanisms including the maintenance of long-term memory against Plasmodium sp antigens. and other infectious agents: Bartonella sp., Babesia sp., smallpox virus, measles, hepatitis.

Time frame
Day 0
2

Kinetics of splenic clearance of altered or modified circulating elements

Explore the spleen filter role during infections, illnesses or use of blood cells, including properties of cells retained in the spleen, possibily after modification in vitro.

Time frame
Day 0
3

Exploring splenic clearance mechanisms

Clearance mechanisms: tissue and cellular topography and concentration of deposition of normal or altered or modified cells in the spleen (Histology, Imaging, Electron Microscopy, etc.).

Time frame
Day 0
4

Exploring the genetic control of spleen function

Genetic control of spleen function.

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Institut Pasteur

Collaborator

URC-CIC Paris Descartes Necker Cochin

Collaborator