Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD-01  

Official title:

Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110252
• Other study ID #: upeclin/ASSIS Unesp - 001
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: February 22, 2012
• Start date: May 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 72 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Drug:
• Stem cells stimulation
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.

Procedure:
• stem cells collection
pullout of 200ml of bone marrow through the puncture of the iliac crest

Genetic:
• stem cells infusion
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.

Locations

Country	Name	City	State
Brazil	Laboratório de Genética Humana e Terapia Celular	Assis	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Instituto de Molestias Cardiovasculares, Laboratório de Genética Humana e Terapia Celular, Unesp - Assis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity (FVC)	A pulmonary function test that measures the volume and speed of the inhalated air.	baseline and 30 days after procedure	Yes
Primary	Forced Expiratory Volume (FEV1)	A pulmonary function test that measures the volume and speed of the exhaled air.	baseline and 30 days after procedure	Yes
Primary	Vital Capacity - VC	A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.	baseline and 30 days after the procedure	Yes
Secondary	Arterial Blood Gases Test - Pa O2	presence of oxygen in the blood gases.	baseline and 30 days after procedure	Yes
Secondary	Arterial Blood Gases Test - Pa CO2	presence of CO2 in the arterial blood.	baseline and 30 days after the procedure	Yes