Clinical trial

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

Active, not recruiting · Phase 1, Phase 2 · 1 countries · Registry ID NCT06448052

Active, not recruitingPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 64 Years

SexAll

Healthy volunteersNot accepted

ConditionInflammatory Disease, Aging Problems, Obese, Lipid Metabolism Disorders, Diabetes

Full registry criteria

Inclusion Criteria: * 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 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.

Treatments and study arms

umbilical cord mesenchymal stem cell

Biological

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).

Primary outcomes

Adverse effectFrom 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 effectFrom 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

DNA International Hospital🌐 Ho Chi Minh City, District 05, Vietnam

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