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Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01110252
Acronym
COPD-01
Enrollment
4
Registered
2010-04-26
Start date
2009-05-31
Completion date
2011-11-30
Last updated
2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema

Keywords

Chronic Obstructive Pulmonary Disease, Emphysema, Cell therapy, Bone marrow mononuclear cells, stem cells

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).

Interventions

DRUGStem cells stimulation

Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.

PROCEDUREstem cells collection

pullout of 200ml of bone marrow through the puncture of the iliac crest

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

Sponsors

Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
CollaboratorUNKNOWN
Instituto de Molestias Cardiovasculares
CollaboratorOTHER
UPECLIN HC FM Botucatu Unesp
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 72 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Forced Vital Capacity (FVC)baseline and 30 days after procedureA pulmonary function test that measures the volume and speed of the inhalated air.
Forced Expiratory Volume (FEV1)baseline and 30 days after procedureA pulmonary function test that measures the volume and speed of the exhaled air.
Vital Capacity - VCbaseline and 30 days after the procedureA pulmonary function test that measures the volume and speed of the inhalated and exhaled air.

Secondary

MeasureTime frameDescription
Arterial Blood Gases Test - Pa CO2baseline and 30 days after the procedurepresence of CO2 in the arterial blood.
Arterial Blood Gases Test - Pa O2baseline and 30 days after procedurepresence of oxygen in the blood gases.

Countries

Brazil

Participant flow

Recruitment details

From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled

Pre-assignment details

Patients signed the Knowledge and Free Consent Instrument (TCLE)

Participants by arm

ArmCount
Prior Then Post Procedure (Stem Cells Infusion)
emphysema patients evaluated prior or after the infusion of the autologous stem cells
4
Total4

Baseline characteristics

CharacteristicPrior Then Post Procedure (Stem Cells Infusion)
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
Age Continuous65.75 years
STANDARD_DEVIATION 1
Region of Enrollment
Brazil
4 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 4
serious
Total, serious adverse events
0 / 4

Outcome results

Primary

Forced Expiratory Volume (FEV1)

A pulmonary function test that measures the volume and speed of the exhaled air.

Time frame: baseline and 30 days after procedure

Population: all patients were evaluated prior and after the procedure

ArmMeasureValue (MEAN)Dispersion
Prior to the Procedure (Stem Cells Infusion)Forced Expiratory Volume (FEV1)0.7 litersStandard Deviation 0.1
Post Procedure (Stem Cells Infusion)Forced Expiratory Volume (FEV1)0.8 litersStandard Deviation 0.1
Primary

Forced Vital Capacity (FVC)

A pulmonary function test that measures the volume and speed of the inhalated air.

Time frame: baseline and 30 days after procedure

Population: all patients were evaluated prior and after the procedure

ArmMeasureValue (MEAN)Dispersion
Prior to the Procedure (Stem Cells Infusion)Forced Vital Capacity (FVC)1.5 litersStandard Deviation 0.2
Post Procedure (Stem Cells Infusion)Forced Vital Capacity (FVC)2.1 litersStandard Deviation 0.2
Primary

Vital Capacity - VC

A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.

Time frame: baseline and 30 days after the procedure

Population: all patients were evaluated prior and after the procedure.

ArmMeasureValue (MEAN)Dispersion
Prior to the Procedure (Stem Cells Infusion)Vital Capacity - VC1.8 litersStandard Deviation 0.3
Post Procedure (Stem Cells Infusion)Vital Capacity - VC1.4 litersStandard Deviation 0.3
Secondary

Arterial Blood Gases Test - Pa CO2

presence of CO2 in the arterial blood.

Time frame: baseline and 30 days after the procedure

Population: all patients were evaluated prior and after the procedure

ArmMeasureValue (MEAN)Dispersion
Prior to the Procedure (Stem Cells Infusion)Arterial Blood Gases Test - Pa CO248.75 mm HgStandard Deviation 2.7
Post Procedure (Stem Cells Infusion)Arterial Blood Gases Test - Pa CO289.25 mm HgStandard Deviation 2.7
Secondary

Arterial Blood Gases Test - Pa O2

presence of oxygen in the blood gases.

Time frame: baseline and 30 days after procedure

Population: all patients were evaluated prior and after the procedure.

ArmMeasureValue (MEAN)Dispersion
Prior to the Procedure (Stem Cells Infusion)Arterial Blood Gases Test - Pa O269 mmHgStandard Deviation 3
Post Procedure (Stem Cells Infusion)Arterial Blood Gases Test - Pa O257 mmHgStandard Deviation 3

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026