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

NCT06536712 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IR.TUMS.IKHC.REC.1403.114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with early anastomotic leakage

  Failed surgical anastomosis after surgery measured with interview and physical examinations in follow-up sessions in clinic

  1 month

Secondary Outcomes (3)

• Mean serum and peritoneal Interleukin-6 and Tumor necrosis factor-alpha levels in participants

  1 month

• Anastomosis integrity in Colonoscopy exam

  1 month

• Hospitalization length of stay

  1 month

Study Arms (2)

Mesenchymal Stem Cells Derived Exosomes

EXPERIMENTAL

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

Biological: Mesenchymal Stem Cells Derived Exosomes

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Mesenchymal Stem Cells Derived Exosomes BIOLOGICAL

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

Mesenchymal Stem Cells Derived Exosomes

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Stage II-III rectal cancer who underwent neoadjuvant chemoradiation therapy and are candidates for low anterior resection surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran

Tehran, 1419733141, Iran

Location

Related Publications (5)

• Platell C, Barwood N, Dorfmann G, Makin G. The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis. 2007 Jan;9(1):71-9. doi: 10.1111/j.1463-1318.2006.01002.x.

  PMID: 17181849 BACKGROUND

• Lipska MA, Bissett IP, Parry BR, Merrie AE. Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg. 2006 Jul;76(7):579-85. doi: 10.1111/j.1445-2197.2006.03780.x.

  PMID: 16813622 BACKGROUND

• Choi HK, Law WL, Ho JW. Leakage after resection and intraperitoneal anastomosis for colorectal malignancy: analysis of risk factors. Dis Colon Rectum. 2006 Nov;49(11):1719-25. doi: 10.1007/s10350-006-0703-2.

  PMID: 17051321 BACKGROUND

• Barnhoorn MC, Wasser MNJM, Roelofs H, Maljaars PWJ, Molendijk I, Bonsing BA, Oosten LEM, Dijkstra G, van der Woude CJ, Roelen DL, Zwaginga JJ, Verspaget HW, Fibbe WE, Hommes DW, Peeters KCMJ, van der Meulen-de Jong AE. Long-term Evaluation of Allogeneic Bone Marrow-derived Mesenchymal Stromal Cell Therapy for Crohn's Disease Perianal Fistulas. J Crohns Colitis. 2020 Jan 1;14(1):64-70. doi: 10.1093/ecco-jcc/jjz116.

  PMID: 31197361 BACKGROUND

• Tashak Golroudbari H, Banikarimi SP, Ayati A, Hadizadeh A, Khorasani Zavareh Z, Hajikhani K, Heirani-Tabasi A, Ahmadi Tafti M, Davoodi S, Ahmadi Tafti H. Advanced micro-/nanotechnologies for exosome encapsulation and targeting in regenerative medicine. Clin Exp Med. 2023 Oct;23(6):1845-1866. doi: 10.1007/s10238-023-00993-7. Epub 2023 Jan 27.

  PMID: 36705868 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Seyed Mohsen Ahmadi Tafti, MD

  Colorectal Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences,

  STUDY DIRECTOR

Central Study Contacts

Seyed Mohsen Ahmadi Tafti, MD

CONTACT

+98(912)2109773; smahmadit@sina.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

IR (1)