Clinical trial NCT01110252: Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
Official title: Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Emphysema
Keywords: Chronic Obstructive Pulmonary Disease
Emphysema
Cell therapy
Bone marrow mononuclear cells
stem cells
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
name: Instituto de Molestias Cardiovasculares
First posted: 2010-04-26
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: baseline and 30 days after procedure
measure: Forced Expiratory Volume (FEV1)
timeFrame: baseline and 30 days after procedure
measure: Vital Capacity - VC
timeFrame: baseline and 30 days after the procedure
Secondary outcomes:
measure: Arterial Blood Gases Test - Pa O2
timeFrame: baseline and 30 days after procedure
measure: Arterial Blood Gases Test - Pa CO2
timeFrame: baseline and 30 days after the procedure
Other outcomes:
Locations:
city: Assis
country: Brazil
facility: Laboratório de Genética Humana e Terapia Celular
state: São Paulo
Study officials:
affiliation: geneticist
name: João T Ribeiro-Paes, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: surgeon
name: Aldemir Bilaqui, MD
role: STUDY_DIRECTOR
affiliation: cardiologist
name: Oswaldo T Greco, MD
role: STUDY_CHAIR
affiliation: hematologist
name: Milton A Ruiz, MD
role: STUDY_CHAIR
affiliation: surgeon
name: José D Araújo, MD
role: STUDY_CHAIR
affiliation: technician
name: Mario R Lago, Ms
role: STUDY_CHAIR
References:
citation: Ribeiro-Paes JT, Stessuk T, Marcelino M, Faria C, Marinelli T, Ribeiro-Paes MJ. A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease. Rev Port Pneumol. 2014 Mar-Apr;20(2):84-91. doi: 10.1016/j.rppneu.2013.06.008. Epub 2013 Nov 26. English, Portuguese.
citation: Ribeiro-Paes JT, Bilaqui A, Greco OT, Ruiz MA, Marcelino MY, Stessuk T, de Faria CA, Lago MR. Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema. Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:63-71. doi: 10.2147/COPD.S15292.