Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418256
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Physiology and Pathologies Linked to Human Splenic Function Direct and Ex-vivo Perfusion Explorations
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Physiology and Pathologies Linked to Human Splenic Function Direct and Ex-vivo Perfusion Explorations
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPLEENVIVO
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 studys 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 eg 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 studys 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 eg 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 andor perfusion experiments with populations of altered or modified cells andor immunological andor 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 flushedrinsed with 01 - 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
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 andor perfusion experiments with populations of altered or modified cells andor immunological andor 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 flushedrinsed with 01 - 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00654-43 | OTHER | IDRCB Number | None |