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Trial Title:
Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection
NCT ID:
NCT06536712
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Mesenchymal Stem Cells Derived Exosomes
Description:
Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to
patients at the end of their surgery
Arm group label:
Mesenchymal Stem Cells Derived Exosomes
Intervention type:
Other
Intervention name:
Placebo
Description:
10 patients will receive intraperitoneal placebo at the end of their surgery
Arm group label:
Placebo
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-Patients with Stage II-III rectal cancer who underwent neoadjuvant chemoradiation
therapy and are candidates for low anterior resection surgery
Exclusion Criteria:
- Patients who need emergency surgery (presenting with peritonitis or signs of
obstruction)
- Patients with apparent malnutrition or patients who have serum albumin levels of
less than 3 g/dl
- Patients who receive corticosteroids ( an equivalent dose of prednisolone 5 mg/day
or more)
- Patients with chronic pulmonary disease
- Patients who need more than two units of blood transfusion perioperatively
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
Address:
City:
Tehran
Zip:
1419733141
Country:
Iran, Islamic Republic of
Start date:
August 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Tehran University of Medical Sciences
Agency class:
Other
Source:
Tehran University of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06536712
