Stem cell transplantation for chronic obstructive pulmonary disease treatment

Phase 2

Completed

• Conditions: Chronic obstructive pulmonary disease (CODD) stage III and IV; Respiratory; Chronic obstructive pulmonary disease, unspecified

• Registration Number: ISRCTN70443938
• Lead Sponsor: Stem Cell Institute, VNUHCM University of Science, Ho Chi Minh city, Viet Nam

Brief Summary

2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32054512 (added 17/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-05
• Study Start: 2019-10-16
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Respiratory function was measured by medical test to determine a change in FEV1 during 6 months of follow-up of stem cell transplantation<br> 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<br> 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<br> 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<br>