Clinical trial
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
Name
VinmecISC1916
Description
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
Trial arms
Trial start
2020-06-09
Estimated PCD
2021-07-30
Trial end
2022-12-25
Status
Completed
Phase
Early phase I
Treatment
Umbilical Cord Mesenchymal Stem Cells transplantation
Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1 million cells/kg patient body weight via the IV route with a 3-month intervening interval
Arms:
Treatment (UC-MSC trasnplatation)
drug therapy according to Vietnamese MOHS procedure
Salbutamol, Terbutaline
Arms:
Treatment (UC-MSC trasnplatation), control arm
Size
40
Primary endpoint
Adverse events and serious adverse events
up to the 12-month period following treatment
Eligibility criteria
Inclusion Criteria:
* Diagnosed with COPD with stage B, C, or D according to GOLD 2019.
* 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.
* Cancer.
* 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%
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2024-06-04
1 organization
2 products
1 indication
Indication
Chronic Obstructive Pulmonary DiseaseProduct
Drug Therapy