Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection
NCT ID: NCT06536712
Last Updated: 2024-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-08-31
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Mesenchymal Stem Cells Derived Exosomes
10 patients in this arm will receive Mesenchymal Stem Cells Derived Exosomes at the end of their low anterior resection surgery
Mesenchymal Stem Cells Derived Exosomes
Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery
Placebo
10 patients in this arm will receive placebo at the end of their low anterior resection surgery
Placebo
10 patients will receive intraperitoneal placebo at the end of their surgery
Interventions
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Mesenchymal Stem Cells Derived Exosomes
Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery
Placebo
10 patients will receive intraperitoneal placebo at the end of their surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Ahmadi tafti
Assistant professor
Principal Investigators
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Seyed Mohsen Ahmadi Tafti, MD
Role: STUDY_DIRECTOR
Colorectal Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences,
Locations
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Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
Tehran, , Iran
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IR.TUMS.IKHC.REC.1403.114
Identifier Type: -
Identifier Source: org_study_id
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