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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
72
Transplant 100 million autologous adipose-derived mesenchymal stem cells at Day 0 and Day 90
DNA International Hospital
Ho Chi Minh City, District 05, Vietnam
RECRUITINGThe 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.
Time frame: 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.
Time frame: 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.
Time frame: Study endpoint at day 180
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.
Time frame: 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.
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
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.
Time frame: Day 0, Day 90 and Day 180
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.