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Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation
Sponsor: Nguyen Ton Ngoc Huynh
Summary
The goal of this single-group, open-label, phase I/II clinical trial is to evaluate the safety and efficacy of the transplantation of umbilical cord mesenchymal stem cells in aging-related low-grade inflammation patients' pro-inflammatory cytokines. The main questions to answer are: * Is the transplantation of umbilical cord mesenchymal stem cells in aging-related low-grade inflammation patients safe? * Comparison of the expression levels of pro-inflammatory cytokines (IL-1α/β, TNF-α/β, IL-6, IL-11, IL-18, IFN-γ) in the patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the expression levels of anti-inflammatory cytokines (IL-10, TGFβ, IL-1) in the patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the inflammation balance by the ratios of pro-inflammatory cytokines to anti-inflammatory cytokines in the patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the HbA1C index in the diabetes patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparision of the indices of Cholesterol, Triglyceride, LDLc, HDLc in the dislipidemia patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Comparison of the BMI in the obese patient's blood before (day 0), after 90 days, and after 180 days of cell transplantation. * Determination of adverse effect frequency in the patients before (day 0), during, after 90 days, and after 180 days of cell transplatation. Participants will receive two intravenous infusions of 100 million umbilical cord mesenchymal stem cells on days 0 and 90. The patient will be monitored for safety and measured as per the study protocol until day 180.
Official title: The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Transplantation in Aging-related Low-grade Inflammation Patients' Pro-inflammatory Cytokines: a Single-group, Open-label, Phase I/II Clinical Trial
Key Details
Gender
All
Age Range
40 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2023-11-01
Completion Date
2026-10-30
Last Updated
2024-06-07
Healthy Volunteers
No
Interventions
umbilical cord mesenchymal stem cell
A total of 100 million single cells were suspended in 0.9% sterile saline solution and given intravenously at a 5-ml/min rate for 45 min. All patients will get two intravenous autologous infusions on days 0 (D0) and 90 (D90).
Locations (1)
DNA International Hospital
Ho Chi Minh City, District 05, Vietnam