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

NCT06418256 | Recruiting

• 2 other identifiers: NI170032024-A00654-43
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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).

Conditions

Splenectomy

Keywords

Spleen; Human splenic physiology; Splenic clearance; Splenic filtration mechanisms; Perfusion experiments; Role of the spleen in the adaptive immune response; Genetic spleen mechanisms; Blood; Erythrocytes; Leukocytes; Lymphocytes; Malaria; Sickle cell disease; Hereditary spherocytosis

Outcome Measures

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.

  Day 0

Secondary Outcomes (5)

• Exploring splenic immunological mechanisms

  Day 0

• Kinetics of splenic clearance of altered or modified circulating elements

  Day 0

• Exploring splenic clearance mechanisms

  Day 0

• Exploring the genetic control of spleen function

  Day 0

• Explore the impact of preservation processes on organ and cell functions, as well as engraftment

  Day 0

Study Arms (1)

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.

Other: Spleen, blood and plasma collection

Interventions

Spleen, blood and plasma collection 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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut Pasteur: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (5)

Hôpital Beaujon

Clichy, 92110, France

RECRUITING

Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Institut Pasteur

Paris, 75015, France

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Spleen fragments Peripheral blood cells Splenic blood cells, including red blood cells and Peripheral Blood Mononuclear Cells Plasma

MeSH Terms

Conditions

Malaria; Anemia, Sickle Cell; Spherocytosis, Hereditary

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Buffet, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Buffet, MD, PhD

CONTACT

pierre.buffet@aphp.fr

Hélène Morel

CONTACT

1 71 49 63 46; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: October 16, 2016
• Primary Completion (Estimated): October 16, 2031
• Study Completion (Estimated): October 16, 2031
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)