Pulmonary EmphysemaNCT01872624
Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
A study testing Bronchoscopy in people with Pulmonary Emphysema, run by Hospital de Clinicas de Porto Alegre at 3 sites in Brazil.
Trial summary
The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesBrazil
- Study dates
- May 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severe heterogeneous emphysema (heterogeneity > 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units.
- Estimation of collateral ventilation based on fissure with integrity ≥ 75%.
- Total lung capacity> 100% predicted.
- Residual volume> 150% predicted.
- Forced expiratory volume at the first minute <45% predicted.
- Diffusing capacity of the lungs for carbon monoxide <45% predicted.
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- Optimal medical treatment.
- Limitations in daily physical activities.
- Minimum of 4 months without smoking
- Having family support.
- Stage ≥ 2 in modified Medical Research Council Dyspnea Scale (MMRC).
Who cannot join
- Homogenous emphysema.
- Presence of collateral ventilation.
- Use of systemic corticosteroids (prednisone> 20mg/day or equivalent).
- Pulmonary or extrapulmonary infection.
- Coronary heart disease and/or severe ventricular dysfunction.
- Significant renal or liver disease.
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- Immunosuppressive disease.
- Active smoking.
- Cancer prognosis with survival <2 years.
- Psychosocial problems.
- Pregnancy.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Pontificia Universidade Catolica do Parana
Curitiba, Paraná, 80215-901
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-902
About this study
Official title: Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life.
Read the detailed description
In addition to testing the safety of one-way endobronchial valves combined with bone-marrow derived mesenchymal stromal cells, the study will determine the systemic inflammatory potential of cell therapy measured by C-reactive protein levels (CRP), erythrocyte sedimentation rate (ESR) and complete blood count in peripheral blood. Finally, the study will aim at determining if other markers of inflammatory response and remodeling are modulated by this therapy.
- Conditions
- Pulmonary Emphysema
- Being tested
- Bronchoscopy
- Medical subject headings
- Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
| Study group | Role | What they receive |
|---|---|---|
| Valves plus cells | Active comparator | Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves. Receives: Procedure: Bronchoscopy |
| Valves plus saline | Placebo comparator | Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion. Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of lung deficits during the procedure and/or in the 4 months follow-up
Measured: 4 months
Secondary outcomes (3)
Quality of Life
St. George Respiratory Questionnaire
Measured: 120 days
Pulmonary function
Spirometry, flow-volume curve, post-bronchodilator test, determination of residual volume, airway resistance by plethysmography, diffusing capacity of the lung for carbon monoxide, and six-minute walk test
Measured: 120 days
Inflammation
Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmphysemaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, National Research Council, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal do Rio de Janeiro, Pontifícia Universidade Católica do Paraná
- Responsible party
- Principal investigator, Hugo Goulart de Oliveira, Hospital de Clinicas de Porto Alegre
- Investigators
- Hugo G Oliveira, MD, PhD, Principal investigator, Hospital de Clinicas de Porto AlegrePatricia RM Rocco, MD, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872624
- Sponsor's protocol ID
- 13-0150
- Status last verified
- Mar 2015
- First submitted
- 5 Jun 2013
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abreu SC, Antunes MA, Pelosi P, Morales MM, Rocco PR. Mechanisms of cellular therapy in respiratory diseases. Intensive Care Med. 2011 Sep;37(9):1421-31. doi: 10.1007/s00134-011-2268-3. Epub 2011 Jun 9.
PubMed 21656291de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.
PubMed 16840401
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
- ClinicalTrials.gov ID
- NCT01872624
- Acronym / sponsor ID
- 13-0150
- Conditions
- Pulmonary Emphysema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, National Research Council, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal do Rio de Janeiro, Pontifícia Universidade Católica do Paraná
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life.
Detailed description
In addition to testing the safety of one-way endobronchial valves combined with bone-marrow derived mesenchymal stromal cells, the study will determine the systemic inflammatory potential of cell therapy measured by C-reactive protein levels (CRP), erythrocyte sedimentation rate (ESR) and complete blood count in peripheral blood. Finally, the study will aim at determining if other markers of inflammatory response and remodeling are modulated by this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valves plus cells | Active comparator | Procedure: BronchoscopyBronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves. |
| Valves plus saline | Placebo comparator | Procedure: BronchoscopyBronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of severe heterogeneous emphysema (heterogeneity > 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units.
- Estimation of collateral ventilation based on fissure with integrity ≥ 75%.
- Total lung capacity> 100% predicted.
- Residual volume> 150% predicted.
- Forced expiratory volume at the first minute <45% predicted.
Key exclusion criteria (11 listed)
- Homogenous emphysema.
- Presence of collateral ventilation.
- Use of systemic corticosteroids (prednisone> 20mg/day or equivalent).
- Pulmonary or extrapulmonary infection.
- Coronary heart disease and/or severe ventricular dysfunction.
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 |
|---|---|---|
| BronchoscopyBronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells. | Procedure or surgery | Valves plus cells, Valves plus saline |
Primary outcome
Absence of lung deficits during the procedure and/or in the 4 months follow-up
Time frame: 4 months
3 secondary outcomes
Quality of Life
Time frame: 120 days
Pulmonary function
Time frame: 120 days
Inflammation
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Background: PubMed 21656291Abreu SC, Antunes MA, Pelosi P, Morales MM, Rocco PR. Mechanisms of cellular therapy in respiratory diseases. Intensive Care Med. 2011 Sep;37(9):1421-31. doi: 10.1007/s00134-011-2268-3. Epub 2011 Jun 9.
- Background: PubMed 16840401de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.
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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.
Hugo G Oliveira, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Patricia RM Rocco, MD, PhD principal investigator
Universidade Federal do Rio de Janeiro
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Pulmonary Emphysema, run by Hospital de Clinicas de Porto Alegre at 3 sites 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 11 inclusion and 11 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absence of lung deficits during the procedure and/or in the 4 months follow-up (time frame: 4 months). 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 NCT01872624, 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 25 Mar 2015.