Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06448052
• Other study ID #: 133/QÐ-BYT
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: June 2024
• Source: DNA International Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Inflamm-aging is associated with the rate of aging and is significantly related to diseases such as Alzheimer's disease, Parkinson's 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 i.v) 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: October 30, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female aged 40-64 years

• TNF-a index > 11 pg/ml and IL6 index > 1.23 pg/ml

• Possesion of at least two of the following three comorbidities: diabetes, dyslipidemia, and obesity

• Stable use of medications for the previous 3 months to treat the previously mentioned comorbidities

• Agreement to participate in the study and to comply with the research examination and evaluation process

Exclusion Criteria:

• Patients with coagulopathy

• History of or current severe heart failure

• Acute respiratory disease at the time of screening

• Patients with cancer or other acute illness requiring treatment

• History of allergy to anesthetics and antibiotics

• Currently/planning to participate in another clinical trial during the study period

• Possessing additional conditions or circumstances that make it difficult to provide treatment, according to the researcher Pathology of disease in the exclusion criteria was defined according to the Guidelines of the Ministry of Health of Vietnam.

Related Conditions & MeSH terms

• Aging Problems
• Diabetes
• Inflammation
• Inflammatory Disease
• Lipid Metabolism Disorders
• Metabolic Diseases
• Obese

Intervention

Biological:
• 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

Country	Name	City	State
Vietnam	DNA International Hospital	Ho Chi Minh City	District 05

Sponsors (1)

Lead Sponsor	Collaborator
Nguyen Ton Ngoc Huynh

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effect	Adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.	From the patients enrolled in the study until 30 days after the study ended.
Primary	Serve adverse effect	Serve adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.	From the patients enrolled in the study until 30 days after the study ended.
Secondary	the expression levels of pro-inflammatory cytokines	Patients peripheral blood withdraws to measure the levels of IL-1a/ß (pg/mL), TNF-a/ß (pg/mL), IL-6 (pg/mL), IL-11 (pg/mL), IL-18 (pg/mL), IFN-? (pg/mL) by a suitable kit test.	Before (day 0), after 90 days, and after 180 days of cell transplantation
Secondary	the expression levels of anti-inflammatory cytokines	Patients peripheral blood withdraws to measure the levels of IL-10 (pg/mL), TGFß (pg/mL), IL-1 (pg/mL) by a suitable kit test.	Before (day 0), after 90 days, and after 180 days of cell transplantation
Secondary	the inflammation balance	Calculation of the ratios of pro-inflammatory cytokines to anti-inflammatory cytokines in patients	Before (day 0), after 90 days, and after 180 days of cell transplantation
Secondary	Effect in diabetes patient	Diabetes patients peripheral blood withdraws to measure the levels of HbA1C (%) by a suitable kit test.	Before (day 0), after 90 days, and after 180 days of cell transplantation
Secondary	Effect in dislipidemia patient	Dislipidemia patients peripheral blood withdraws to measure the levels of of Cholesterol (mg/dL), Triglyceride (mg/dL), LDLc (mg/dL), HDLc (mg/dL) by a suitable kit test.	Before (day 0), after 90 days, and after 180 days of cell transplantation
Secondary	Effect in obese patient	Obese patients will monitor their weight and calculate their BMI.	Before (day 0), after 90 days, and after 180 days of cell transplantation.