Allogeneic Human Umbilical Cord-derived Mesenchymal Stem/Stromal Cells for Chronic Obstructive Pulmonary Disease (COPD): Study Protocol for a Matched Case-control, Phase I/II Trial
Overview
- Phase
- Phase 1
- Intervention
- drug therapy according to Vietnamese MOHS procedure
- Conditions
- COPD
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse events and serious adverse events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines
Detailed Description
The aim of this trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines. This matched case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between June 2020 and December 2021. In this study, 40 patients will be enrolled and assigned into two age-, gender- and COPD condition-matched groups, including a UC-MSC group and a control group. Both groups will receive standard COPD medication treatment based on the GOLD 2019 guidelines and the Vietnam Ministry of Health protocol. The UC-MSC group will receive two doses of thawed UC-MSC product with an intervention interval of 3 months. The primary outcome measures will include the incidence of prespecified administrationassociated adverse events (AEs) and serious adverse events (SAEs). The efficacy will be evaluated based on the absolute changes in the number of admissions, arterial blood gas analysis, lung function and lung fibrosis via CT scan and chest X-ray. The clinical evaluation will be conducted at baseline and 3, 6, and 12 months post
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with COPD with stage B, C, or D according to GOLD
- •Age between 40-75 years old.
- •Both genders.
Exclusion Criteria
- •Smoker or less than 6 months of smoking cessation time.
- •Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer).
- •Acute and/or active infection.
- •Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
- •Liver and kidney failure.
- •Pregnancy.
- •Patients with life expectancy less than 6 months due to concomitant illness.
- •Under immunosuppressive treatment within 8 weeks of the first screening visit.
- •Patient diagnosed diabetes with HbA1C\>7%
Arms & Interventions
control arm
drug therapy according to Vietnamese MOHS procedure
Intervention: drug therapy according to Vietnamese MOHS procedure
Treatment (UC-MSC trasnplatation)
1 x 10\^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with Vietnames MOH procedure
Intervention: Umbilical Cord Mesenchymal Stem Cells transplantation
Treatment (UC-MSC trasnplatation)
1 x 10\^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with Vietnames MOH procedure
Intervention: drug therapy according to Vietnamese MOHS procedure
Outcomes
Primary Outcomes
Adverse events and serious adverse events
Time Frame: up to the 12-month period following treatment
To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 3 months, 6 months, and 12 months after discharge will be evaluated
Secondary Outcomes
- Respiratory functions (FEV1/FVC)(up to the 12-month period following treatment)
- Respiratory functions (VC)(up to the 12-month period following treatment)
- inflammatory response (Pro-BNP)(up to the 12-month period following treatment)
- cytokine analysis from patients' plasma(up to the 12-month period following treatment)
- Quality of Life using Georges Respiratory Questionnaire(up to the 12-month period following treatment)
- inflammatory response (CRP)(up to the 12-month period following treatment)
- arterial blood gas analysis (pH)(up to the 12-month period following treatment)
- Respiratory functions (FEV1)(up to the 12-month period following treatment)
- Respiratory functions (TLC)(up to the 12-month period following treatment)
- Respiratory functions (DLCO)(up to the 12-month period following treatment)
- inflammatory response (Troponin-T)(up to the 12-month period following treatment)
- Chest CT(up to the 12-month period following treatment)
- arterial blood gas analysis (PaO2)(up to the 12-month period following treatment)
- arterial blood gas analysis (PaCO2)(up to the 12-month period following treatment)
- arterial blood gas analysis (BE)(up to the 12-month period following treatment)
- arterial blood gas analysis (HCO3-)(up to the 12-month period following treatment)
- Respiratory functions (RV)(up to the 12-month period following treatment)
- Respiratory functions (DLNO/DLCO)(up to the 12-month period following treatment)
- modified medical research council(up to the 12-month period following treatment)