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Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hospital de Clinicas de Porto Alegre
Sponsor:
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
Information provided by (Responsible Party):
Hugo Goulart de Oliveira, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01872624
First received: June 5, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Pulmonary Emphysema
Procedure: Bronchoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Absence of lung deficits during the procedure and/or in the 4 months follow-up [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
    St. George Respiratory Questionnaire

  • Pulmonary function [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
    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

  • Inflammation [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
    Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte


Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Valves plus cells
Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.
Procedure: Bronchoscopy
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
Placebo Comparator: Valves plus saline
Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.
Procedure: Bronchoscopy
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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.
  • Immunosuppressive disease.
  • Active smoking.
  • Cancer prognosis with survival <2 years.
  • Psychosocial problems.
  • Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872624

Contacts
Contact: Hugo G Oliveira, MD, PhD +55-52-9865.8151 hugo@oliveira.com

Locations
Brazil
Pontificia Universidade Catolica do Parana Active, not recruiting
Curitiba, PR, Brazil, 80215-901
Universidade Federal do Rio de Janeiro Active, not recruiting
Rio de Janeiro, RJ, Brazil, 21941-902
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Hugo G Oliveira, PhD    555198658151    hugo@oliveira.com   
Contact: Fabio M Svartman, MD    555192492231    fsvartman@hotmail.com   
Principal Investigator: Hugo G Oliveira, MD, PhD         
Sub-Investigator: Fabio M Svartman, MD         
Sub-Investigator: Amarilio V Macedo-Neto, MD, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
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
Investigators
Principal Investigator: Hugo G Oliveira, MD, PhD Hospital de Clínicas de Porto Alegre
Principal Investigator: Patricia RM Rocco, MD, PhD Universidade Federal do Rio de Janeiro
  More Information

Publications:
Responsible Party: Hugo Goulart de Oliveira, Associate Professor, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01872624     History of Changes
Other Study ID Numbers: 13-0150
Study First Received: June 5, 2013
Last Updated: June 5, 2013
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on November 24, 2014