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

Pulmonary Emphysema Clinical Trial

Official title:

Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872624
• Other study ID #: 13-0150
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: March 24, 2015
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Procedure:
• Bronchoscopy
Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.

Locations

Country	Name	City	State
Brazil	Pontificia Universidade Catolica do Parana	Curitiba	PR
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (7)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil, National Research Council, Brazil, Pontifícia Universidade Católica do Paraná, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of lung deficits during the procedure and/or in the 4 months follow-up		4 months	Yes
Secondary	Quality of Life	St. George Respiratory Questionnaire	120 days	Yes
Secondary	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	120 days	Yes
Secondary	Inflammation	Collection of blood samples for determination of C-reactive protein (CRP), erythrocyte	120 days	Yes