Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Emphysema
• Interventions: Drug: Stem cells stimulation; Procedure: stem cells collection; Genetic: stem cells infusion

• Registration Number: NCT01110252
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-26
• Primary Completion: 2010-10
• Study Completion: 2011-11
• Results First Submitted: 2011-11-03
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Results First Posted: 2012-03-26
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pre-procedure	Stem cells stimulation	emphysema patients evaluated prior to the stem cells infusion
pre-procedure	stem cells collection	emphysema patients evaluated prior to the stem cells infusion
pre-procedure	stem cells infusion	emphysema patients evaluated prior to the stem cells infusion
post-procedure	Stem cells stimulation	emphysema patients evaluated 30 days after the stem cells infusion
post-procedure	stem cells collection	emphysema patients evaluated 30 days after the stem cells infusion
post-procedure	stem cells infusion	emphysema patients evaluated 30 days after the stem cells infusion

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	baseline and 30 days after procedure	A pulmonary function test that measures the volume and speed of the inhalated air.
Forced Expiratory Volume (FEV1)	baseline and 30 days after procedure	A pulmonary function test that measures the volume and speed of the exhaled air.
Vital Capacity - VC	baseline and 30 days after the procedure	A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.

Secondary Outcome Measures

Name	Time	Method
Arterial Blood Gases Test - Pa O2	baseline and 30 days after procedure	presence of oxygen in the blood gases.
Arterial Blood Gases Test - Pa CO2	baseline and 30 days after the procedure	presence of CO2 in the arterial blood.

Trial Locations

Locations (1)

Laboratório de Genética Humana e Terapia Celular; 🇧🇷 Assis, São Paulo, Brazil