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临床试验/NCT01110252
NCT01110252已完成不适用

Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

UPECLIN HC FM Botucatu Unesp1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4
试验地点
1
主要终点
Forced Vital Capacity (FVC)

研究概览

简要总结

The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.

详细描述

The main feature of the pulmonary emphysema, included in range of the Chronic Obstructive Pulmonary Disease (COPD), is the airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchiole, without significant pulmonary fibrosis. The existing clinical approaches has contributed to the enlargement and amelioration of the emphysema patients life quality, although no effective or curative treatment has been achieved. The surgical treatment, on the other hand, involves complex procedures and, in the specific case of lung transplantation, a lack of donors.

Considering these aspects, several experimental models have been proposed aiming to increase knowledge about the pathophysiological processes and enable new clinical approaches to the pulmonary emphysema. The cell therapy, briefly described as the use of cells in disease treatment, presents itself as a promising therapeutic approach with great potential applicability in degenerative pulmonary diseases. In this way, it is intended in this project, the proposition of a protocol to evaluate the safety of cell therapy with pool of mononuclear cells from bone marrow in patients with clinical and laboratory diagnosis of pulmonary emphysema in advanced stage (stage IV dyspnea).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of severe chronic obstructive pulmonary disease
  • ineffective clinical treatment
  • limited life expectancy
  • limitations in daily physical activity
  • possibility of pulmonary rehabilitation physiotherapy
  • acceptable nutritional status
  • acceptable cardiac function
  • at least six months smoking cessation
  • family support
  • modified medical research council dyspnea scale stage > 3

排除标准

  • pulmonary or extra-pulmonary infection
  • severe coronary disease and/or ventricular dysfunction
  • significant kidney or liver disease
  • immunosuppressive disease
  • active smoker
  • psychosocial problems
  • established medical protocol
  • family rejection
  • pregnancy

研究组 & 干预措施

pre-procedure

Active Comparator

emphysema patients evaluated prior to the stem cells infusion

干预措施: Stem cells stimulation (Drug)

pre-procedure

Active Comparator

emphysema patients evaluated prior to the stem cells infusion

干预措施: stem cells collection (Procedure)

pre-procedure

Active Comparator

emphysema patients evaluated prior to the stem cells infusion

干预措施: stem cells infusion (Genetic)

post-procedure

Experimental

emphysema patients evaluated 30 days after the stem cells infusion

干预措施: Stem cells stimulation (Drug)

post-procedure

Experimental

emphysema patients evaluated 30 days after the stem cells infusion

干预措施: stem cells collection (Procedure)

post-procedure

Experimental

emphysema patients evaluated 30 days after the stem cells infusion

干预措施: stem cells infusion (Genetic)

结局指标

主要结局

Forced Vital Capacity (FVC)

时间窗: baseline and 30 days after procedure

A pulmonary function test that measures the volume and speed of the inhalated air.

Forced Expiratory Volume (FEV1)

时间窗: baseline and 30 days after procedure

A pulmonary function test that measures the volume and speed of the exhaled air.

Vital Capacity - VC

时间窗: baseline and 30 days after the procedure

A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.

次要结局

  • Arterial Blood Gases Test - Pa O2(baseline and 30 days after procedure)
  • Arterial Blood Gases Test - Pa CO2(baseline and 30 days after the procedure)

研究者

发起方
UPECLIN HC FM Botucatu Unesp
申办方类型
Other
责任方
Principal Investigator
主要研究者

João Tadeu Ribeiro Paes

sponsor

UPECLIN HC FM Botucatu Unesp

研究点 (1)

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