Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536712
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Effect of Intraperitoneal Administration of Exosome in Preventing Early Anastomotic Leakage in Rectal Cancer Patients Who Undergo Low Anterior Resection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess the safety and efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer The main question it aims to answer are
Do Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer
If there is a comparison group Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage
Participants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery
Do Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer
If there is a comparison group Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage
Participants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery
Detailed Description:
Anastomotic leakage remains one of the most severe complications following colorectal surgery leading to increased morbidity prolonged hospitalization and reduced quality of life Despite advances in surgical techniques and perioperative care the incidence of early anastomotic leaks persists Practical strategies to reduce this risk are crucial for improving patient outcomes
Recent studies have highlighted the potential role of mesenchymal stem cell-derived exosomes in enhancing tissue repair and modulating inflammation These extracellular vesicles derived from human placenta mesenchymal stem cells hPMSC contain bioactive molecules such as proteins lipids and RNA that facilitate cellular communication and promote healing processes Preclinical research suggests that exosomes can support anastomotic healing by reducing local inflammation
This study aims to evaluate the safety and efficacy of intraperitoneal administration of hPMSC-derived exosomes in preventing early anastomotic leakage in patients undergoing low anterior resection LAR for rectal cancer We hypothesize that the exosome treatment will significantly reduce the incidence of anastomotic leaks compared to placebo thereby improving postoperative recovery and reducing hospital stay
Recent studies have highlighted the potential role of mesenchymal stem cell-derived exosomes in enhancing tissue repair and modulating inflammation These extracellular vesicles derived from human placenta mesenchymal stem cells hPMSC contain bioactive molecules such as proteins lipids and RNA that facilitate cellular communication and promote healing processes Preclinical research suggests that exosomes can support anastomotic healing by reducing local inflammation
This study aims to evaluate the safety and efficacy of intraperitoneal administration of hPMSC-derived exosomes in preventing early anastomotic leakage in patients undergoing low anterior resection LAR for rectal cancer We hypothesize that the exosome treatment will significantly reduce the incidence of anastomotic leaks compared to placebo thereby improving postoperative recovery and reducing hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None