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

Tehran University of Medical Sciences

Status and phase: Not yet enrolling; Phase 1

Conditions: Rectal Cancer

Treatments: Biological: Mesenchymal Stem Cells Derived Exosomes; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06536712

IR.TUMS.IKHC.REC.1403.114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Mesenchymal Stem Cells Derived Exosomes

Experimental group

Description:

10 patients in this arm will receive Mesenchymal Stem Cells Derived Exosomes at the end of their low anterior resection surgery

Treatment:

Biological: Mesenchymal Stem Cells Derived Exosomes

Placebo

Placebo Comparator group

Description:

10 patients in this arm will receive placebo at the end of their low anterior resection surgery

Treatment:

Other: Placebo