Autologous Infusion of Bone Marrow and Mesenchymal Stromal Cells in Patients with Chronic Obstructive Pulmonary Disease: Phase I Randomized Clinical Trial.

BACKGROUND AND OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is characterized by the destruction of alveolar walls, chronic inflammation and persistent respiratory symptoms. There is no curative clinical treatment for COPD. In this context, cell-based therapy is a promising therapeutic alternative for COPD. Thus, in this open, controlled and randomized Phase I Clinical Trial, we aimed to assess the safety of the infusion of autologous bone marrow mononuclear cells (BMMC), adipose-derived mesenchymal stromal cells (ADSC) and, especially, the safety of concomitant infusion (co-infusion) of BMMC and ADSC as a new therapeutic alternative for COPD. The rationale for co-infusion of BMMC and ADSC is based on the hypothesis of an additive or synergistic therapeutic effect resulting from this association. METHODS: To achieve the proposed objectives, twenty patients with moderate-to-severe COPD were randomly divided into four groups: control group - patients receiving conventional treatment; BMMC group - patients receiving only BMMC; ADSC group - patients receiving only ADSC, and co-infusion group - patients receiving the concomitant infusion of BMMC and ADSC. Patients were assessed for pulmonary function, biochemical profile, and quality of life over a 12 months follow-up. RESULTS: No adverse events were detected immediately after the infusion of BMMC, ADSC or co-infusion. In the 12-month follow-up, no causal relationship was established between adverse events and cell therapy procedures. Regarding the efficacy, the BMMC group showed an increase in forced expiratory volume (FEV1) and diffusing capacity for carbon monoxide (DLCO). Co-infusion group showed a DLCO, and gas exchange improvement and a better quality of life. CONCLUSION: The results obtained allow us to conclude that cell-based therapy with co-infusion of BMMC and ADSC is a safe procedure and a promising therapeutic for COPD. However, additional studies with a greater number of patients are needed before randomized and controlled Phase III clinical trials can be implemented.

Impact of activities in self-esteem of patients in a pulmonary rehabilitation program.

OBJECTIVE: To evaluate self-esteem and self-image of respiratory diseases patients in a Pulmonary Rehabilitation Program, who participated in socialization and physical fitness activities, and of patients who participated only in physical fitness sessions. METHODS: A descriptive cross-sectional exploratory study. Out of a total of 60 patients analyzed, all enrolled in the Pulmonary Rehabilitation Program, 42 participated in at least one of the proposed activities, 10 did not participate in any activity and 8 were excluded (7 were discharged and 1 died). RESULTS: When the two groups were compared, despite the fact that both demonstrated low self-esteem and self-image, the difference between them was relevant (p<0.05) regarding self-esteem, indicating that those who participated in the proposed socialization activities had better self-esteem than the individuals who only did the physical fitness sessions. Regarding self-image, the difference between the groups was not relevant (p>0.05). CONCLUSION: The Pulmonary Rehabilitation Program patients evaluated presented low self-esteem and self-image; however, those carrying out some socialization activity proposed had better self-esteem as compared to the individuals who did only the physical fitness sessions.

Impact of activities in self-esteem of patients in a pulmonary rehabilitation program / Impacto das atividades na autoestima dos pacientes em um programa de reabilitação pulmonar

Objective To evaluate self-esteem and self-image of respiratory diseases patients in a Pulmonary Rehabilitation Program, who participated in socialization and physical fitness activities, and of patients who participated only in physical fitness sessions. Methods A descriptive cross-sectional exploratory study. Out of a total of 60 patients analyzed, all enrolled in the Pulmonary Rehabilitation Program, 42 participated in at least one of the proposed activities, 10 did not participate in any activity and 8 were excluded (7 were discharged and 1 died). Results When the two groups were compared, despite the fact that both demonstrated low self-esteem and self-image, the difference between them was relevant (p<0.05) regarding self-esteem, indicating that those who participated in the proposed socialization activities had better self-esteem than the individuals who only did the physical fitness sessions. Regarding self-image, the difference between the groups was not relevant (p>0.05). Conclusion The Pulmonary Rehabilitation Program patients evaluated presented low self-esteem and self-image; however, those carrying out some socialization activity proposed had better self-esteem as compared to the individuals who did only the physical fitness sessions. .

Objetivo Avaliar a autoestima e a autoimagem de pacientes com doenças respiratórias de um Programa de Reabilitação Pulmonar, que participaram de atividades de socialização e de treinamento físico e de pacientes que participaram apenas de treinamentos físicos. Métodos Estudo exploratório descritivo e transversal. Foram analisados 60 pacientes, todos inclusos em um Programa de Reabilitação Pulmonar. Destes, 42 participaram de pelo menos uma das atividades propostas, 10 não participaram das atividades e 8 foram excluídos (7 tiveram alta e 1 faleceu), não respondendo ao questionário de autoimagem e autoestima. Resultados Quando comparados os dois grupos, apesar de ambos terem apresentado autoestima e autoimagem baixas, a diferença entre eles foi significativa (p<0,05) com relação à autoestima: aqueles que participaram de atividades de socialização propostas pela equipe tiveram autoestima melhor que a dos sujeitos que participam apenas do treinamento físico. Já quanto à autoimagem, a diferença entre os grupos não foi significativa (p>0,05). Conclusão Os pacientes do Programa de Reabilitação Pulmonar avaliados apresentaram baixas autoestima e autoimagem, porém aqueles que realizaram alguma atividade de socialização proposta tiveram a autoestima maior comparada à dos que fizeram apenas o treinamento físico. .

Comparison between the 6-minute walk tests performed in patients with chronic obstructive pulmonary disease at different altitudes / Comparação entre os testes de caminhada de 6 minutos realizados em pacientes com doença pulmonar obstrutiva crônica em diferentes altitudes

Objective To evaluate the influence of the altitude on the 6-minute walking test in patients with moderate to severe pulmonary disease. Methods Twenty-nine patients performed the 6-minute walk test at a pulmonary rehabilitation clinic in Santo André (above sea level), in São Paulo State, and at the Enseada Beach, in Guarujá (at sea level), also in São Paulo State. Of these 29 patients, 8 did the test both on hard sand and on asphalt to analyze if there were differences in performance during the tests. Data such as heart rate, oxygen saturation, test distance, and Borg scale were compared. Results We found no statistical difference in relation to oxygen saturation at rest before the beginning of the walking test in Santo André 94.67±2.26% and at sea level 95.56±2% (p=0.71). The minimum saturation measured during the test was 87.27±6.54% in Santo André and 89.10±5.41% in Guarujá (p=0.098). There were no differences in the performed distance between the different kinds of terrains; the distance on sand was 387.75±5.02m and on asphalt it was 375.00±6.54m (p=0.654). Regarding oxygen saturation during walking, the pulse oximetry on sand was 95.12±1.80% and on asphalt it was 96.87±1.64% (p=1.05). Conclusion Altitude did not affect the performance of the walking test in patients with moderate to severe pulmonary disease and the results were similar in both cases, on sand and on asphalt. .

Objetivo Avaliar a influência da altitude no teste de caminhada de 6 minutos em pacientes com doença pulmonar moderada a grave. Métodos Vinte e nove pacientes realizaram o teste de caminhada de 6 minutos em um ambulatório de reabilitação pulmonar, na cidade de Santo André (acima do nível do mar), em São Paulo, e na praia da Enseada no Guarujá (ao nível do mar), também em São Paulo. Destes, oito pacientes realizaram tanto na areia batida como no asfalto, para avaliar a existência de alguma alteração no desempenho durante o teste. Dados como frequência cardíaca, saturação de oxigênio, distância do teste e escala de Borg foram comparados. Resultados Não encontramos diferença estatística em relação à saturação de oxigênio em repouso antes do início do teste de caminhada em Santo André 94,67±2,26% e ao nível do mar 95,56±2% (p=0,71). A saturação mínima obtida durante os testes foi de 87,27±6,54%, em Santo André, e de 89,10±5,41%, no Guarujá (p=0,098). Não houve diferença na distância percorrida e nos diferentes tipos de piso; a distância na areia foi de 387,75±5,02m e 375,00±40,88m no asfalto (p=0,654). Quanto à saturação durante a caminhada, a oximetria de pulso na areia foi de 95,12±1,80% e no asfalto foi de 96,87±1,64% (p=1,05), ou seja, o teste foi reprodutível em ambos os solos. Conclusão A altitude não influenciou o desempenho do teste de caminhada realizado por pacientes com doença pulmonar moderada a grave, sendo reprodutível tanto acima quanto ao nível do mar, mesmo ...

Comparison between the 6-minute walk tests performed in patients with chronic obstructive pulmonary disease at different altitudes.

OBJECTIVE: To evaluate the influence of the altitude on the 6-minute walking test in patients with moderate to severe pulmonary disease. METHODS: Twenty-nine patients performed the 6-minute walk test at a pulmonary rehabilitation clinic in Santo André (above sea level), in São Paulo State, and at the Enseada Beach, in Guarujá (at sea level), also in São Paulo State. Of these 29 patients, 8 did the test both on hard sand and on asphalt to analyze if there were differences in performance during the tests. Data such as heart rate, oxygen saturation, test distance, and Borg scale were compared. RESULTS: We found no statistical difference in relation to oxygen saturation at rest before the beginning of the walking test in Santo André 94.67±2.26% and at sea level 95.56±2% (p=0.71). The minimum saturation measured during the test was 87.27±6.54% in Santo André and 89.10±5.41% in Guarujá (p=0.098). There were no differences in the performed distance between the different kinds of terrains; the distance on sand was 387.75±5.02m and on asphalt it was 375.00±6.54m (p=0.654). Regarding oxygen saturation during walking, the pulse oximetry on sand was 95.12±1.80% and on asphalt it was 96.87±1.64% (p=1.05). CONCLUSION: Altitude did not affect the performance of the walking test in patients with moderate to severe pulmonary disease and the results were similar in both cases, on sand and on asphalt.

Estudo comparativo da função pulmonar em pacientes submetidos a revascularização do miocárdio com irculação extracorpórea em uso de drenos pleural e mediastinal versus dreno mediastinal / Comparative study of the pulmonary function in patients submitted to myocardial

Objetivo: Comparar as alterações da função pulmonar no período pós-operatório com uso de drenos pleural e mediastinal ou somente dreno mediastinal, verificando se a utilização do dreno pleural, além do mediastinal traz maiores repercussões à função pulmonar no pós-operatório. Essa avaliação auxilia a escolha de exercícios fisioterapêuticos específicos que atendam as necessidades individuais dos pacientes. Método: Dezesseis pacientes com idade média de 65 anos e fatores de risco para doença coronariana foram avaliados. Excluíram-se três pacientes, sendo que o restante foi dividido em dois grupos de acordo com a quantidade de drenos, a saber: Grupo 1 (n = 8), com dreno mediastinal e Grupo 2 (n = 5), com drenos pleural e mediastinal. Todos os pacientes foram submetidos à avaliação da função pulmonar através da mensuração da pressãoinspiratória máxima, da pressão expiratória máxima, do volume corrente e da mobilidade torácica. As medidas foram obtidas no pré e até o quinto dia pós-operatório. Resultados: Em ambos os grupos houve alterações, no pós-operatório, da pressão inspiratória máxima, da pressão expiratória máxima e da mobilidade torácica. Porém, apenas a alteração do volume corrente foi estatisticamente significante (p ≤ 0,05). Conclusão: Os pacientes do Grupo 2 tiveram uma diminuição mais acentuda do volume corrente quando comparados aos pacientes do Grupo 1.

Aim: To compare the alterations of the pulmonary function during the post-operative between patients using pleural and mediastinal drains or only mediastinal drain, verifying if the use of the pleural drain besides the mediastinal brings larger changes in pulmonary selection of physiotherapy specific exercises that involve the individual necessity of patients. Method: We evaluated sixteen patients with an average of 65 years, who present coronary disease. Three patients were excluded and the other 13 were divided into two groups according to the amount of drains, as follows: Group 1 (n = 8), with mediastinal drain and Group 2 (n = 5), with pleural and mediastinal drains. All patients were submitted to pulmonary function evaluation, it measured the maximun inspiratory and expiratory pressures, the tidal volume and the mobility of the thoracic box in the pre-operative and until the fifth post-operative day. Results: In both groups there were changes, in the post-operative period, in the maximun inspiratory and expiratory pressures and in the mobility of the thoracic box. Although, only the tidal volume alterations were statistically significant (p ≤ 0.05). Conclusion: Patients from Group 2 presented tidal volume reduction when compared to patients from Group.