NCT01110252

Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: UPECLIN HC FM Botucatu Unesp · Academic / Other
• Sex: All
• Age: 40 Years – 72 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Obstructive Pulmonary Disease
• Pulmonary Emphysema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-10-01
• Completion: 2011-11-01
• First posted: 2010-04-26
• Last updated: 2012-03-26
• Results posted: 2012-03-26

Locations

1 site across 1 country: Brazil