Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448052
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-01
Brief Title:
Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation
Sponsor:
Nguyen Ton Ngoc Huynh
Organization:
DNA International Hospital
Study Overview
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 III Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this single-group open-label phase III 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-1αβ TNF-αβ IL-6 IL-11 IL-18 IFN-γ in the patients 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 patients 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 patients blood before day 0 after 90 days and after 180 days of cell transplantation
Comparison of the HbA1C index in the diabetes patients 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 patients blood before day 0 after 90 days and after 180 days of cell transplantation
Comparison of the BMI in the obese patients 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
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-1αβ TNF-αβ IL-6 IL-11 IL-18 IFN-γ in the patients 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 patients 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 patients blood before day 0 after 90 days and after 180 days of cell transplantation
Comparison of the HbA1C index in the diabetes patients 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 patients blood before day 0 after 90 days and after 180 days of cell transplantation
Comparison of the BMI in the obese patients 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
Detailed Description:
Inflamm-aging is associated with the rate of aging and is significantly related to diseases such as Alzheimers disease Parkinsons disease atherosclerosis heart disease and age-related degenerative diseases such as type II diabetes and osteoporosis This study aims to evaluate the safety and efficiency of Umbilical cord mesenchymal stem cell UC-MSC transplantation in aging-related low-grade inflammation patients This study is a single-group open-label phase I clinical trial in which patients treated with 2 infusions 100 million cells iv of UC-MSC were evaluated in inflamm-aging patients who concurrently had highly proinflammatory cytokines and 2 of the following 3 diseases diabetes dyslipidemia and obesity The treatment effects were evaluated based on plasma cytokines related to inflammation HbA1C index in diabetes patients the levels of of Cholesterol Triglyceride LDLc HDLc in dislipidemia patients BMI in obese patients The patient will be monitored for safety during the study protocol according to the Common Terminology Criteria for Adverse Events CTCAE V5 NIH The assessment of the effectiveness at days 0 90 and 180 after cell transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None