## Protocol Section
### Identification Module
**NCT ID:** NCT06418256

**Acronym:** SPLEENVIVO

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

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

#### Organization Study ID Info
**ID:** NI17003
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** IDRCB Number
**ID:** 2024-A00654-43
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2031-10-16

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2031-10-16

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-10-16

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Institut Pasteur

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**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

### Design Module

#### Bio Spec

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

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Spleen, blood and plasma collection

**Label:** Patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients

**Description:** 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.

**Name:** Spleen, blood and plasma collection

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

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

**Time Frame:** Day 0

#### Secondary Outcomes

**Description:** 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.

**Measure:** Exploring splenic immunological mechanisms

**Time Frame:** Day 0

**Description:** 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.

**Measure:** Kinetics of splenic clearance of altered or modified circulating elements

**Time Frame:** Day 0

**Description:** 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.).

**Measure:** Exploring splenic clearance mechanisms

**Time Frame:** Day 0

**Description:** Genetic control of spleen function.

**Measure:** Exploring the genetic control of spleen function

**Time Frame:** Day 0

**Description:** Testing optimized freezing methods with evaluation of cell function in vitro and engraftment in a mouse model.

**Measure:** Explore the impact of preservation processes on organ and cell functions, as well as engraftment

**Time Frame:** Day 0

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pierre.buffet@aphp.fr

**Name:** Pierre Buffet, MD, PhD

**Role:** CONTACT

**Contact 2:**

**Email:** helene.morel@aphp.fr

**Name:** Hélène Morel

**Phone:** 1 71 49 63 46

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Clichy

**Contacts:**

***Contact 1:***

- **Email:** alain.sauvanet@aphp.fr

- **Name:** Alain Sauvanet, MD, PhD

- **Phone:** 1 40 87 55 84

- **Phone Ext:** + 33

- **Role:** CONTACT

***Contact 2:***

- **Email:** safi.dokmak@aphp.fr

- **Name:** Safi Dokmak

- **Phone:** 1 40 87 57 97

- **Phone Ext:** + 33

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Beaujon

**Status:** RECRUITING

**Zip:** 92110

**Location 2:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** françois.paye@aphp.fr

- **Name:** François Paye, MD, PhD

- **Phone:** 1 49 28 25 61

- **Phone Ext:** + 33

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Saint Antoine

**Status:** RECRUITING

**Zip:** 75012

**Location 3:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** christophe.tresallet@aphp.fr

- **Name:** Christophe Trésallet, MD, PhD

- **Phone:** 1 42 17 66 03

- **Phone Ext:** + 33

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Pitié Salpêtrière

**Status:** RECRUITING

**Zip:** 75013

**Location 4:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** pierre.buffet@aphp.fr

- **Name:** Pierre Buffet, MD, PhD

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Necker-Enfants Malades

**Status:** RECRUITING

**Zip:** 75015

**Location 5:**

**City:** Paris

**Country:** France

**Facility:** Institut Pasteur

**Status:** ACTIVE_NOT_RECRUITING

**Zip:** 75015

#### Overall Officials

**Official 1:**

**Affiliation:** Assistance Publique - Hôpitaux de Paris

**Name:** Pierre Buffet, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4085

- Name: Anemia, Sickle Cell

- Relevance: LOW

- As Found: Unknown

- ID: M11280

- Name: Malaria

- Relevance: LOW

- As Found: Unknown

- ID: M15901

- Name: Spherocytosis, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: T3571

- Name: Malaria

- Relevance: LOW

- As Found: Unknown

- ID: T5229

- Name: Sickle Cell Anemia

- Relevance: LOW

- As Found: Unknown

- ID: T2782

- Name: Hereditary Spherocytosis

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
