Infusion of stem cells in people with Chronic Obstructive Pulmonary Disease: improvement of quality of life and physical performance.

Phase 3

• Conditions: Chronic obstructive pulmonary disease; C08.381.495.389

• Registration Number: RBR-6wrxxh
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

patients aged between 40 and 70 years, of both gender, treatment optimized for COPD with grade 2 or 3 persistent dyspnea that is, they were all using beta 2 long duration associated with long-acting anticholinergic and inhaled corticosteroids, forced expiratory volume in the 1st second (FEV1) of 30-50%; possibility of being submitted to the pulmonary rehabilitation program; cessation of tobacco addiction for at least six months.

Exclusion Criteria

patients with: absence of emphysema on chest tomography; active pulmonary or extrapulmonary infection or history of infectious disease for less than 3 months; previous history of coronary artery disease and / or severe ventricular dysfunction; presence of pulmonary hypertension; home oxygen therapy; advanced or hepatic renal insufficiency; detected immunosuppressive or infectious diseases; carriers of known neoplasms and collagenoses.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The results showed that participants undergoing SCT treatment had improvement in QoL relative to the control group. The Co-infusion group showed improvement of 47.62% over the baseline score; the MSC-AT group, 34.22%; and the BMMC group 10.39%.In relation to the 6MWT, the distance covered by the groups did not present a significant difference.;Presentation of the expected outcome: Improvement in the Quality of Life and physical performance in all treated groups. Quality of life was analyzed with Saint George´s Respiratory Questionary. Score could rise from 0 up to 100. A 10% decrease in the score is considered an improvement in the quality of life. Six minute walk test is measured in meters and an increase of 50m is considered a significant improvement.<br><br>

Secondary Outcome Measures

Name	Time	Method
o secundary outcomes we expected.