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| Name | Class |
|---|---|
| University of Science Ho Chi Minh City | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC transplantation | Experimental | Transplant 100 million MSCs |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous adipose-derived mesenchymal stem cell transplantation | Biological | Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Study endpoint at day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huynh Nguyen, MD | Contact | +84 982902928 | bshuynhnguyen@benhvienquoctedna.vn | |
| Nhung H Truong, Ph.D | Contact | +84 907974904 | thnhung@hcmus.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DNA International Hospital | Recruiting | Ho Chi Minh City | District 05 | 70000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38715140 | Derived | 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. |
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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.
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| 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. | 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. | Day 0, Day 90 and Day 180 |