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Cell Therapy Associated With Endobronchial Valve (CEL&VAL)

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ClinicalTrials.gov Identifier: NCT04018729
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
Pontifícia Universidade Católica do Paraná
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

Chronic obstructive pulmonary disease (COPD) is one of the most common diseases worldwide and is considered a public health problem. The World Health Organization estimates that about 210 million people have COPD. Disease-related mortality is more than 3 million, representing 5% of all deaths, 90% of this mortality being concentrated in middle- and low-income countries. COPD can be subdivided into chronic bronchitis and emphysema. Emphysema, the focus of this project, is histologically defined by the permanent increase of the distal air spaces to the terminal bronchioles associated with the destruction of the alveolar septa in the lung. Approximately two-thirds of adult men and a quarter of women (most without dysfunction) will have well-defined emphysema, but often of limited extent.

Mesenchymal stem cells (MSCs) have anti-inflammatory, anti-fibrotic, microbicide and repair potential. Regarding COPD, several authors have concentrated efforts in the investigation of the relationship between the severity of the condition and the various sources of adult stem cells. Apparently the lungs have a high chemotactic effect in relation to adult stem cells, since several studies have evidenced a high implantation (6-20%) of stem cells derived from bone marrow, administered systemically, in the pulmonary tissue of receptors. Therefore, MSCs has been tested in different lung diseases have no effective treatment, such as pulmonary fibrosis, acute respiratory distress syndrome, asthma, COPD positive results, such as reduction of fibrosis, reduction of proliferation inflammatory cells and cytokines, reduction of infectious processes and recovery of the histological changes caused by pulmonary emphysema.

Based on these findings, the purpose of this project is to evaluate the safety and efficacy of endoscopic administration of bone marrow stem cells in patients with severe homogeneous emphysema and evaluating the feasibility, efficacy and safety of this procedure.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Severe Device: Zephyr Endobronchial Valve Biological: Marrow-derived mesenchymal stromal cell Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bone Marrow-Derived Mesenchymal Stromal Cell Therapy Associated With Unidirectional Endobronchial Valve in Patients With Severe Pulmonary Emphysema: A Randomized Clinical Trial
Estimated Study Start Date : August 5, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Endobronchial valve + marrow-derived mesenchymal stromal cell Device: Zephyr Endobronchial Valve
Endoscopic lung volume reduction therapy.

Biological: Marrow-derived mesenchymal stromal cell
Mesenchymal stem cells have anti-inflammatory, anti-fibrotic, microbicide and repair potential.

Active Comparator: Endobronchial valve Device: Zephyr Endobronchial Valve
Endoscopic lung volume reduction therapy.




Primary Outcome Measures :
  1. All-cause death [ Time Frame: 6 months ]
    Expressed as the total number of death due to all conditions during the clinical trial.

  2. Number of participants with worsening of dyspnea [ Time Frame: 6 months ]
    Number of participants with worsening of dyspnea as measured by the mMRC-Modified Medical Research Council (1 point increase in the measured scale). The mMRC Dyspnea Scale quantifies disability attributable to breathlessness (range from 1-4), and is useful for characterizing baseline dyspnea in patients with respiratory diseases.

  3. Number of participants with respiratory functional worsening [ Time Frame: 6 months ]
    Number of participants with respiratory functional worsening as measured by decrease of 15% or more in FEV1 (forced expiratory volume in one second). FEV1 is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second.

  4. Impairment of exercise capacity [ Time Frame: 6 months ]
    Impairment of exercise capacity as measured by reduction of 35 m in the 6-minute walk test. The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

  5. Increased oxygen use [ Time Frame: 6 months ]
    Outcome measure result: number of participants with 1 point increase in oxygen need as classification on the chart above 0 - no oxygen use 1- intermittent use <6h/day 2- intermittent use >6h/dia 3 - continuous oxygen use



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of severe heterogeneous pulmonary emphysema (at least 15% of total lung parenchyma or 25% of target lobe with density < -950HU);
  • Heterogeneity> 15pp (difference of at least 15 percentage points of lung parenchyma with density greater than -950HU between the treated lobe(s) and the remaining lung on the same side)
  • Estimates of low or non-existent collateral ventilation (fissure integrity> 90% measured by VIDA Diagnostics or collateral ventilation measured by negative Chartis® System)
  • Total lung capacity> 100% of predicted
  • Residual volume> 150% of predicted
  • FEV1 <45% of predicted post-bronchodilator
  • DLCO (diffusing capacity of the lungs for carbon monoxide) <45% of predicted post-bronchodilator
  • Optimized clinical treatment
  • Daily physical activities limitation
  • Possibility of pulmonary rehabilitation
  • Preserved ventricular function (LVEF> 40%)
  • Cessation of smoking ≥ 4 months
  • Dyspnea MMRC ≥ 2

Exclusion Criteria:

  • Homogeneous emphysema
  • Estimated collateral ventilation observed on CT scanned by VIDA vision software (VIDA vision®, VIDA Diagnostics, Iowa-USA) - Fissure integrity on target lobe less than 75%.
  • Use of continuous systemic corticosteroid therapy> 20mg QD (quaque die, once a day) of prednisone (or equivalent)
  • Active lung or extra pulmonary infection
  • Coronary heart disease and/or severe ventricular dysfunction
  • Significant renal or hepatic disease
  • Immunosuppressive disease
  • Active smoking
  • Malignant neoplasia with estimated prognosis of survival <2 years
  • Psychosocial problems
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018729


Contacts
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Contact: Hugo G Oliveira, PhD +55 51 3359-8241 ext 8241 hugo@hugooliveira.org

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Pontifícia Universidade Católica do Paraná
Universidade Federal do Rio de Janeiro
Investigators
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Principal Investigator: Hugo G Oliveira, PhD Hospital de Clinicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04018729     History of Changes
Other Study ID Numbers: 2018-0327
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases