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

Autologous Stem Cell infusion in COPD patients: impact on quality of life and physical performance.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6wrxxh
Enrollment
Unknown
Registered
2018-12-03
Start date
2015-10-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

1) Control - 5 patients were observed over 12 months and evaluated for disease progression. No intervention was performed beyond the usual drug treatment for the disease. 2) Bone Marrow Mononuclear Ce
isolation of the fraction of mononuclear cells in suspension of 30 ml of physiological solution
3) Mesenchymal Stem Cells-Adipose Tissue (MSC-TA) 5 patients - 1x 108 infusion of mesenchymal cells in suspension of 30ml of physiological solution. The cells were obtained from adipose tissue extract
4) Coinfusion MSC-AT + BMMC 5 patients submitted to bone marrow puncture and to the collection of adipose tissue. The collection of adipose tissue was performed previously and after isolation and cult
Genetics
G04.144.220.235

Sponsors

Faculdade de Medicina do ABC
Lead Sponsor
IEP-São Lucas
Collaborator
Laboratório de Genética e Terapia Celular - GenTe Cel UNESP - Campus de Assis
Collaborator

Eligibility

Age
40 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. ;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.

Secondary

MeasureTime frame
No secundary outcomes we expected.

Countries

Brazil

Contacts

Public ContactElie ;Selma Fiss;Squassoni

Faculdade de Medicina do ABC;Faculdade de Medicina do ABC

eliefiss@uol.com.br;selma_denis@yahoo.com.br55011982841515;5501144383558

Outcome results

None listed

Source: REBEC (via WHO ICTRP)