Chronic Obstructive Pulmonary DiseaseCOPD-01NCT01110252
Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
A study testing Stem cells stimulation, stem cells collection and stem cells infusion in people with Chronic Obstructive Pulmonary Disease and Pulmonary Emphysema, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 72 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema
- What is being tested?
- Stem cells stimulation, stem cells collection and stem cells infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- acceptable cardiac function
- at least six months smoking cessation
- family support
- modified medical research council dyspnea scale stage > 3
Who cannot join
- pulmonary or extra-pulmonary infection
- severe coronary disease and/or ventricular dysfunction
- significant kidney or liver disease
- immunosuppressive disease
- active smoker
- cancer
Show all 10Show fewer
- psychosocial problems
- established medical protocol
- family rejection
- pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratório de Genética Humana e Terapia Celular
Assis, São Paulo, 19.806-900
About this study
Official title: Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
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.
Read the 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).
- Being tested
- Stem cells stimulation, stem cells collection, stem cells infusion
- Keywords
- Chronic Obstructive Pulmonary Disease, Emphysema, Cell therapy, Bone marrow mononuclear cells, stem cells
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cells stimulationDrug
Also called Filgrastin - ACHÉ Laboratories.
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
stem cells collectionProcedure or surgery
Also called bone marrow harvest
pullout of 200ml of bone marrow through the puncture of the iliac crest
stem cells infusionGenetic
Also called adult stem cell infusion
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
| Study group | Role | What they receive |
|---|---|---|
| pre-procedure | Active comparator | emphysema patients evaluated prior to the stem cells infusion Receives: Drug: Stem cells stimulation; Procedure: stem cells collection; Genetic: stem cells infusion |
| post-procedure | Experimental | emphysema patients evaluated 30 days after the stem cells infusion Receives: Drug: Stem cells stimulation; Procedure: stem cells collection; Genetic: stem cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
A pulmonary function test that measures the volume and speed of the inhalated air.
Measured: baseline and 30 days after procedure
Forced Expiratory Volume (FEV1)
A pulmonary function test that measures the volume and speed of the exhaled air.
Measured: baseline and 30 days after procedure
Vital Capacity - VC
A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
Measured: baseline and 30 days after the procedure
Secondary outcomes (2)
Arterial Blood Gases Test - Pa O2
presence of oxygen in the blood gases.
Measured: baseline and 30 days after procedure
Arterial Blood Gases Test - Pa CO2
presence of CO2 in the arterial blood.
Measured: baseline and 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratório de Genética Humana e Terapia Celular, Unesp - Assis, Instituto de Molestias Cardiovasculares
- Responsible party
- Principal investigator, João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp
- Investigators
- João T Ribeiro-Paes, PhD MD, Principal investigator, geneticistAldemir Bilaqui, MD, Study director, surgeonOswaldo T Greco, MD, Study chair, cardiologistMilton A Ruiz, MD, Study chair, hematologistJosé D Araújo, MD, Study chair, surgeonMario R Lago, Ms, Study chair, technician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110252
- Sponsor's protocol ID
- upeclin/ASSIS Unesp - 001
- Acronym
- COPD-01
- Status last verified
- Feb 2012
- First submitted
- 20 Apr 2010
- Last updated
- 26 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24287082Ribeiro-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.
PubMed 21311694
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01110252
- Acronym / sponsor ID
- COPD-01 / upeclin/ASSIS Unesp - 001
- Keywords
- Chronic Obstructive Pulmonary Disease, Emphysema, Cell therapy, Bone marrow mononuclear cells, stem cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Laboratório de Genética Humana e Terapia Celular, Unesp - Assis, Instituto de Molestias Cardiovasculares
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-procedure | Active comparator | Drug: Stem cells stimulation, Procedure: stem cells collection, Genetic: stem cells infusionemphysema patients evaluated prior to the stem cells infusion |
| post-procedure | Experimental | Drug: Stem cells stimulation, Procedure: stem cells collection, Genetic: stem cells infusionemphysema patients evaluated 30 days after the stem cells infusion |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosis of severe chronic obstructive pulmonary disease
- ineffective clinical treatment
- limited life expectancy
- limitations in daily physical activity
- possibility of pulmonary rehabilitation physiotherapy
Key exclusion criteria (10 listed)
- pulmonary or extra-pulmonary infection
- severe coronary disease and/or ventricular dysfunction
- significant kidney or liver disease
- immunosuppressive disease
- active smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cells stimulationAlso: Filgrastin - ACHÉ Laboratories.Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure. | Drug | post-procedure, pre-procedure |
| stem cells collectionAlso: bone marrow harvestpullout of 200ml of bone marrow through the puncture of the iliac crest | Procedure or surgery | post-procedure, pre-procedure |
| stem cells infusionAlso: adult stem cell infusionslow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline. | Genetic | post-procedure, pre-procedure |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: baseline and 30 days after procedure
A pulmonary function test that measures the volume and speed of the inhalated air.
Forced Expiratory Volume (FEV1)
Time frame: baseline and 30 days after procedure
A pulmonary function test that measures the volume and speed of the exhaled air.
Vital Capacity - VC
Time frame: baseline and 30 days after the procedure
A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
2 secondary outcomes
Arterial Blood Gases Test - Pa O2
Time frame: baseline and 30 days after procedure
Arterial Blood Gases Test - Pa CO2
Time frame: baseline and 30 days after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24287082Ribeiro-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.
- Derived from this study: PubMed 21311694Ribeiro-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João T Ribeiro-Paes, PhD MD principal investigator
geneticist
Aldemir Bilaqui, MD study director
surgeon
Oswaldo T Greco, MD study chair
cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stem cells stimulation, stem cells collection and stem cells infusion in people with Chronic Obstructive Pulmonary Disease and Pulmonary Emphysema, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: baseline and 30 days after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110252, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.