ClinicalTrials.Veeva

Menu

Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease (COPD-01)

U

UPECLIN HC FM Botucatu Unesp

Status

Completed

Conditions

Pulmonary Emphysema
Chronic Obstructive Pulmonary Disease

Treatments

Procedure: stem cells collection
Drug: Stem cells stimulation
Genetic: stem cells infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01110252
upeclin/ASSIS Unesp - 001

Details and patient eligibility

About

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.

Full 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).

Enrollment

4 patients

Sex

All

Ages

40 to 72 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 2 patient groups

pre-procedure
Active Comparator group
Description:
emphysema patients evaluated prior to the stem cells infusion
Treatment:
Genetic: stem cells infusion
Drug: Stem cells stimulation
Procedure: stem cells collection
post-procedure
Experimental group
Description:
emphysema patients evaluated 30 days after the stem cells infusion
Treatment:
Genetic: stem cells infusion
Drug: Stem cells stimulation
Procedure: stem cells collection

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems