NCT01872624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

June 5, 2013

Last Update Submit

March 24, 2015

Conditions

Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

  • Absence of lung deficits during the procedure and/or in the 4 months follow-up

    4 months

Secondary Outcomes (3)

  • Quality of Life

    120 days

  • Pulmonary function

    120 days

  • Inflammation

    120 days

Study Arms (2)

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.

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.

Procedure: Bronchoscopy

Interventions

BronchoscopyPROCEDURE

Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

Valves plus cellsValves plus saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pontificia Universidade Catolica do Parana

Curitiba, Paraná, 80215-901, Brazil

Location

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-902, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 21656291BACKGROUND

  • de 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.

    PMID: 16840401BACKGROUND

MeSH Terms

Conditions

Pulmonary Emphysema

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Pulmonary Disease, Chronic ObstructiveLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Hugo G Oliveira, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Patricia RM Rocco, MD, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 7, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

BR(3)