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Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection

NCT06536712 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-05

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Mesenchymal Stem Cells Derived Exosomes

Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery

OTHER

Placebo

10 patients will receive intraperitoneal placebo at the end of their surgery

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Seyed Mohsen Ahmadi Tafti, MD · Colorectal Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences,

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06536712 on ClinicalTrials.gov