Chronic obstructive pulmonary disease (CODD) stage III and IV Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Patients were infused with 1-2 million cells of allogeneic in vitro expanded mesenchymal stem cells derived from umbilical cord tissues per kg body weight.
The umbilical cord was coll
then followed-up up to 6 months
Sponsors
Stem Cell Institute, VNUHCM University of Science, Ho Chi Minh city, Viet Nam
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosed with COPD stage C and D in accordance with GOLD 2016 2. Aged between 40 and 80 years old 3. Understand and agree to the written consent form
Exclusion criteria
Exclusion criteria: 1. Current smoker or smoking cessation with the time of cessation less than 6 months; 2. Asthma or clinically relevant lung diseases other than COPD (lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, lung cancer) 3. Active infection requiring antibiotic therapy 4. Active Mycobacterium infection 5. Clinically relevant not associated with COPD during screening: Left ventricle ejection fraction lower than 40%, valvular heart disease, cardiomyopathy disease, arrhythmia, congenital heart disease, kidney failure with Creatinine index > 2.0 mg/dl, liver disease with AST, ALT or bilirubin 2 times more than upper limit of normal range, haematological disorder or cancer 6. Using TNF inhibitor within 3 months prior to the screening visit 7. Using an immunosuppressive medicine 8 weeks prior to the screening visit 8. Active malignancy or history of cancer without recurrence within 5 years prior to the screening visit 9. Taking part in other clinical trials with any medicine or medical device 10. Unable to perform all of the assessments required for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in pulmonary function determined by the incidence, frequency and/or severity of adverse events over 6 months after treatment compared to the same before treatment using patient notes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Respiratory function was measured by medical test to determine a change in FEV1 during 6 months of follow-up of stem cell transplantation 2. Exercise capability was measured by medical test to determine a change in 6-minute walking test during 6 months of follow-up after stem cell treatment 3. The degree of dyspnea was assessed by questionnaires to determine the mMRC and CAT scales before and 1month, 3 months, 6 months after stem cell treatment 4. The improvement of inflammatory response was measured by medical test to determine CRP concentration in the body before and 1month, 3 months, 6 months after stem cell treatment | — |
Countries
Viet Nam
Contacts
Public ContactPhuong;Phuc Le Thi Bich;Van Pham
;
Outcome results
None listed