Aging ProblemsPhase 1/2NCT05827757
Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.
A Phase 1/2 study testing autologous adipose-derived mesenchymal stem cell transplantation in people with Aging Problems and Aging, run by DNA International Hospital at 1 site in Vietnam.
Trial summary
Single-group, open-label, phase I / II clinical trial: Evaluation of the safety of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Aging Problems, Aging, Chronic Inflammation
- What is being tested?
- autologous adipose-derived mesenchymal stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Apr 2020to 13 Apr 2025
- 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 patient, age 40 to 64 years.
- The inflammatory aging patient as defined in the protocol as TNF alpha or IL6 at the time of screening was higher than the 95% healthy percentile value declared by the test system manufacturer.
- Have at least 2 of the 3 following diseases:
- Diabetes type II
- Dyslipidemia
- Obesity [The diagnosis and determination of accompanying diseases (Diabetes, Dyslipidemia, Obesity) will be carried out according to the general guidance of the MOH Vietnam].
- Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months.
- Agree to participate in research and agree to comply with the research examination and evaluation process.
Who cannot join
- Patients with a blood-clotting disorder or hemophilia
- Patients with severe heart failure
- Acute respiratory pathology at the time of screening
- Patients with cancer or other acute illness need treatment.
- Patients with a history of allergy to anesthetics, anesthesia, and antibiotics
- Patients are planning to participate in another clinical trial while participating in the study
- There are other conditions or circumstances in which it is difficult for researchers to ensure adherence to treatment in the judgment of researchers.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
DNA International Hospital
Ho Chi Minh City, District 05, 70000
Hao T Phan, MD, +84 917446633, drhao@benhvienquoctedna.vn
H
About this study
Official title: Single-group, Open-label, Phase I / II Clinical Trial: Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Cytokines Balance in Inflammaging (Ageing-related Low-grade Inflammation) Patients.
Single-group, open-label, phase I / II clinical trial: Evaluation of the safety of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients.
Read the detailed description
The proposed study is a single-group, open-label, phase I / II clinical trial in which the patients will be treated with two doses (100 million i.v) of autologous adipose tissue-derived mesenchymal stem cell transplantation.
This study aims to evaluate the safety and efficiency of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients. The inflammaging-patients are who have cytokine increasing (IL6 and TNF alfa)
- Conditions
- Aging Problems, Aging, Chronic Inflammation
- Being tested
- autologous adipose-derived mesenchymal stem cell transplantation
- Keywords
- Ageing-related low-grade inflammation;, inflammaging;, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose-derived mesenchymal stem cell transplantationBiological
Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90
| Study group | Role | What they receive |
|---|---|---|
| MSC transplantation | Experimental | Transplant 100 million MSCs Receives: Biological: autologous adipose-derived mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and toleration of stem cell infusion
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Study recruirement day 0
The safety and toleration of stem cell infusion
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Day 90
The safety and toleration of stem cell infusion
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Study endpoint at day 180
Secondary outcomes (3)
The change of proinflammatory cytokines after stem cell transplantation in patients
The measurement of proinflammatory cytokines concentration in patients peripheral blood such as IL-1α (pg/ml), IL-1β (pg/ml), TNF-α (pg/ml), TNF-β (pg/ml), IL-6 (pg/ml), IL-11 (pg/ml), IL-18 (pg/ml), IFN-γ (pg/ml) at day 0, 90, and 180 after stem cell infusion.
During the study period, the variation of cytokine levels in individual patients revealed the results.
Measured: Day 0, Day 90 and Day 180
The change of anti-inflammatory cytokines after stem cell transplantation in patients
At day 0, 90, and 180 after stem cell infusion, the concentration of anti-inflammatory cytokines such as IL - 4 (pg/ml), IL-10 (pg/ml), EGF (pg/ml), and MCP-1 (pg/ml) in the peripheral blood of patients is measured.
During the study period, the variation of cytokine levels in individual patients revealed the results.
Measured: Day 0, Day 90 and Day 180
The influence of stem cell transplantation on thechange of the ratio of pro-inflammatory to anti-inflammatory cytokines
The ratio of pro-inflammatory cytokines to anti-inflammatory cytokines will be used to assess the inflammation balance. The ratios from baseline were compared to three and six months after stem cell infusion such as IL-4/IL-10, IL-1/IL-10, IL-6/IL-10, and IL-1/EGF will be reported.
Measured: Day 0, Day 90 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start28 Apr 2020
- Primary completion13 Apr 2025 (estimated)
- Study completion13 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DNA International Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Science Ho Chi Minh City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827757
- Sponsor's protocol ID
- 1690/QĐ-BYT
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2020
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen NT, Phan HT, Le PM, Nguyen LT, Do TT, Phan TT, Van Le T, Dang TM, Phan CL, Dang TT, Truong NH. Safety and efficacy of autologous adipose tissue-derived stem cell transplantation in aging-related low-grade inflammation patients: a single-group, open-label, phase I clinical trial. Trials. 2024 May 8;25(1):309. doi: 10.1186/s13063-024-08128-3.
PubMed 38715140
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-group, Open-label, Phase I / II Clinical Trial: Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Cytokines Balance in Inflammaging (Ageing-related Low-grade Inflammation) Patients.
- ClinicalTrials.gov ID
- NCT05827757
- Acronym / sponsor ID
- 1690/QĐ-BYT
- Conditions
- Aging Problems, Aging, Chronic Inflammation
- Keywords
- Ageing-related low-grade inflammation;, inflammaging;, aging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- DNA International HospitalUniversity, hospital or other
- Collaborators
- University of Science Ho Chi Minh City
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 13 Apr 2025 (estimated)
- Study completion
- 13 Apr 2025 (estimated)
- First posted
- 25 Apr 2023 (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.
Single-group, open-label, phase I / II clinical trial: Evaluation of the safety of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients.
Detailed description
The proposed study is a single-group, open-label, phase I / II clinical trial in which the patients will be treated with two doses (100 million i.v) of autologous adipose tissue-derived mesenchymal stem cell transplantation.
This study aims to evaluate the safety and efficiency of autologous adipose tissue-derived mesenchymal stem cell transplantation in inflammaging (Ageing-related low-grade inflammation) patients. The inflammaging-patients are who have cytokine increasing (IL6 and TNF alfa)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluating the Safety and Efficacy of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Transplantation on Proinflammatory Cytokines and Anti-inflammatory Cytokines on Ageing-related Low-grade Inflammation Patients.
| Arm | Type | Receives |
|---|---|---|
| MSC transplantation | Experimental | Biological: autologous adipose-derived mesenchymal stem cell transplantationTransplant 100 million MSCs |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female patient, age 40 to 64 years.
- The inflammatory aging patient as defined in the protocol as TNF alpha or IL6 at the time of screening was higher than the 95% healthy percentile value declared by the test system manufacturer.
- Have at least 2 of the 3 following diseases:
- Patients are using stable drugs for co-infection (diabetes mellitus, dyslipidemia, obesity) stably in the past 3 months.
- Agree to participate in research and agree to comply with the research examination and evaluation process.
Key exclusion criteria (7 listed)
- Patients with a blood-clotting disorder or hemophilia
- Patients with severe heart failure
- Acute respiratory pathology at the time of screening
- Patients with cancer or other acute illness need treatment.
- Patients with a history of allergy to anesthetics, anesthesia, 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 |
|---|---|---|
| autologous adipose-derived mesenchymal stem cell transplantationTransplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90 | Biological | MSC transplantation |
Primary outcome
The safety and toleration of stem cell infusion
Time frame: Study recruirement day 0
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
The safety and toleration of stem cell infusion
Time frame: Day 90
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
The safety and toleration of stem cell infusion
Time frame: Study endpoint at day 180
Assess the safety and tolerance of autologous adipose-derived mesenchymal stem cell transplantation in patients with inflammatory aging. During the entire duration of the study, the likelihood of adverse event occurrence and adverse event effects related or unrelated to stem cell infusion will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
3 secondary outcomes
The change of proinflammatory cytokines after stem cell transplantation in patients
Time frame: Day 0, Day 90 and Day 180
The change of anti-inflammatory cytokines after stem cell transplantation in patients
Time frame: Day 0, Day 90 and Day 180
The influence of stem cell transplantation on thechange of the ratio of pro-inflammatory to anti-inflammatory cytokines
Time frame: Day 0, Day 90 and Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 38715140Nguyen NT, Phan HT, Le PM, Nguyen LT, Do TT, Phan TT, Van Le T, Dang TM, Phan CL, Dang TT, Truong NH. Safety and efficacy of autologous adipose tissue-derived stem cell transplantation in aging-related low-grade inflammation patients: a single-group, open-label, phase I clinical trial. Trials. 2024 May 8;25(1):309. doi: 10.1186/s13063-024-08128-3.
Related trials for Aging Problems
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruitingObservational study
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging)
Aging Problems
Active, not recruiting
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Dementia, Dementia, Vascular
RecruitingEarly Phase 1
Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
Aging, Balance Deficits
Active, not recruiting
Brain Health Virtual Reality Study
Aging, Aging Problems
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.
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 autologous adipose-derived mesenchymal stem cell transplantation in people with Aging Problems and Aging, run by DNA International Hospital 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 8 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 4 Oct 2023. 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?
Contact Huynh Nguyen, MD (+84 982902928, bshuynhnguyen@benhvienquoctedna.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and toleration of stem cell infusion (time frame: Study recruirement day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827757, which also lists 1 linked publication.
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 4 Oct 2023.