Inflammatory DiseasePhase 1/2NCT06448052
Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation
A Phase 1/2 study testing umbilical cord mesenchymal stem cell in people with Inflammatory Disease and Aging Problems, run by Nguyen Ton Ngoc Huynh at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Inflammatory Disease, Aging Problems, Obese
- What is being tested?
- umbilical cord mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2023to 30 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged 40-64 years
- TNF-α 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Being tested
- umbilical cord mesenchymal stem cell
- Keywords
- mesenchymal stem cell, low-grade inflammation, Inflammaging, Obese, dislipidemia, diabetes
- Medical subject headings
- Obesity, Lipid Metabolism Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC transplantation | Experimental | Participants will receive two intravenous infusions of 100 million umbilical cord mesenchymal stem cells on days 0 and 90. Receives: Biological: umbilical cord mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effect
Adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.
Measured: From the patients enrolled in the study until 30 days after the study ended.
Serve adverse effect
Serve adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.
Measured: From the patients enrolled in the study until 30 days after the study ended.
Secondary outcomes (6)
the expression levels of pro-inflammatory cytokines
Patients peripheral blood withdraws to measure the levels of IL-1α/β (pg/mL), TNF-α/β (pg/mL), IL-6 (pg/mL), IL-11 (pg/mL), IL-18 (pg/mL), IFN-γ (pg/mL) by a suitable kit test.
Measured: Before (day 0), after 90 days, and after 180 days of cell transplantation
the expression levels of anti-inflammatory cytokines
Patients peripheral blood withdraws to measure the levels of IL-10 (pg/mL), TGFβ (pg/mL), IL-1 (pg/mL) by a suitable kit test.
Measured: Before (day 0), after 90 days, and after 180 days of cell transplantation
the inflammation balance
Calculation of the ratios of pro-inflammatory cytokines to anti-inflammatory cytokines in patients
Measured: Before (day 0), after 90 days, and after 180 days of cell transplantation
Effect in diabetes patient
Diabetes patients peripheral blood withdraws to measure the levels of HbA1C (%) by a suitable kit test.
Measured: Before (day 0), after 90 days, and after 180 days of cell transplantation
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.
Measured: Before (day 0), after 90 days, and after 180 days of cell transplantation
Effect in obese patient
Obese patients will monitor their weight and calculate their BMI.
Measured: Before (day 0), after 90 days, and after 180 days of cell transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Nov 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single-group, open-label, phase I/II clinical trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nguyen Ton Ngoc Huynh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nguyen Ton Ngoc Huynh, DNA International Hospital
- Investigators
- Nguyen TN Huynh, MD, Principal investigator, DNA International General Hospital, Ho Chi Minh City 700000, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448052
- Sponsor's protocol ID
- 133/QĐ-BYT
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06448052
- Acronym / sponsor ID
- 133/QĐ-BYT
- Keywords
- mesenchymal stem cell, low-grade inflammation, Inflammaging, Obese, dislipidemia, diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nguyen Ton Ngoc HuynhUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single-group, open-label, phase I/II clinical trial
| Arm | Type | Receives |
|---|---|---|
| UC-MSC transplantation | Experimental | Biological: umbilical cord mesenchymal stem cellParticipants will receive two intravenous infusions of 100 million umbilical cord mesenchymal stem cells on days 0 and 90. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 40-64 years
- TNF-α 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| umbilical cord mesenchymal stem cellA 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). | Biological | UC-MSC transplantation |
Primary outcome
Adverse effect
Time frame: From the patients enrolled in the study until 30 days after the study ended.
Adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.
Serve adverse effect
Time frame: From the patients enrolled in the study until 30 days after the study ended.
Serve adverse effect will be monitored according to Common Terminology Criteria for Adverse Events (CTCAE) V5, NIH.
6 secondary outcomes
the expression levels of pro-inflammatory cytokines
Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation
the expression levels of anti-inflammatory cytokines
Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation
the inflammation balance
Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation
Effect in diabetes patient
Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation
Effect in dislipidemia patient
Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation
Effect in obese patient
Time frame: Before (day 0), after 90 days, and after 180 days of cell transplantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Yes. At the end of the study
Related trials for Inflammatory Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nguyen TN Huynh, MD principal investigator
DNA International General Hospital, Ho Chi Minh City 700000, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cell in people with Inflammatory Disease and Aging Problems, run by Nguyen Ton Ngoc Huynh at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effect (time frame: From the patients enrolled in the study until 30 days after the study ended.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.