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晚期慢性阻塞性肺疾病患者细胞治疗的I期临床试验:长达3年的随访

Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years.

作者信息

Stessuk Talita, Ruiz Milton Artur, Greco Oswaldo Tadeu, Bilaqui Aldemir, Ribeiro-Paes Maria José de Oliveira, Ribeiro-Paes João Tadeu

机构信息

Universidade de São Paulo - USP, São Paulo, SP, Brazil.

出版信息

Rev Bras Hematol Hemoter. 2013;35(5):352-7. doi: 10.5581/1516-8484.20130113.

Abstract

BACKGROUND

Chronic obstructive pulmonary disease is a major inflammatory disease of the airways and an enormous therapeutic challenge. Within the spectrum of chronic obstructive pulmonary disease, pulmonary emphysema is characterized by the destruction of the alveolar walls with an increase in the air spaces distal to the terminal bronchioles but without significant pulmonary fibrosis. Therapeutic options are limited and palliative since they are unable to promote morphological and functional regeneration of the alveolar tissue. In this context, new therapeutic approaches, such as cell therapy with adult stem cells, are being evaluated.

OBJECTIVE

This article aims to describe the follow-up of up to 3 years after the beginning of a phase I clinical trial and discuss the spirometry parameters achieved by patients with advanced pulmonary emphysema treated with bone marrow mononuclear cells.

METHODS

Four patients with advanced pulmonary emphysema were submitted to autologous infusion of bone marrow mononuclear cells. Follow-ups were performed by spirometry up to 3 years after the procedure.

RESULTS

The results showed that autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry) and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life.

CONCLUSIONS

Despite being in the initial stage and in spite of the small sample, the results of the clinical protocol of cell therapy in advanced pulmonary emphysema as proposed in this study, open new therapeutic perspectives in chronic obstructive pulmonary disease. It is worth emphasizing that this study corresponds to the first study in the literature that reports a change in the natural history of pulmonary emphysema after the use of cell therapy with a pool of bone marrow mononuclear cells.

摘要

背景

慢性阻塞性肺疾病是一种主要的气道炎症性疾病,也是一个巨大的治疗挑战。在慢性阻塞性肺疾病范围内,肺气肿的特征是肺泡壁破坏,终末细支气管远端气腔增大,但无明显肺纤维化。治疗选择有限且为姑息性的,因为它们无法促进肺泡组织的形态和功能再生。在此背景下,正在评估新的治疗方法,如成人干细胞的细胞治疗。

目的

本文旨在描述一项I期临床试验开始后长达3年的随访情况,并讨论接受骨髓单个核细胞治疗的晚期肺气肿患者所达到的肺量计参数。

方法

4例晚期肺气肿患者接受了自体骨髓单个核细胞输注。术后通过肺量计进行长达3年的随访。

结果

结果表明,慢性阻塞性肺疾病患者的自体细胞治疗是一种安全的操作,且无不良反应。实验室参数(肺量计)有所改善,病理退变过程减缓。此外,患者报告临床状况和生活质量有所改善。

结论

尽管本研究尚处于初始阶段且样本量较小,但本研究中所提出的晚期肺气肿细胞治疗临床方案的结果,为慢性阻塞性肺疾病开辟了新的治疗前景。值得强调的是,本研究是文献中第一项报道使用骨髓单个核细胞池进行细胞治疗后肺气肿自然病程发生变化的研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/03b2/3832317/45ebafcf1295/rbhh-35-05-0352-g01.jpg

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