Safety of Stem Cells Intrabronchial Instillation for Silicosis
SilicStemCell
Phase-1 Study of Autologous Bone Marrow Cells Intrabronchial Instillation for Patients Silicosis
1 other identifier
interventional
5
1 country
1
Brief Summary
The aim of this study was to analyze the safety, pulmonary function, and quality of life data of patients with silicosis treated with intrabronchial instillation of bone marrow derived mononuclear cells (BMDMC, 2x107) through bronchoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 27, 2015
May 1, 2015
1.7 years
November 10, 2010
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of lung deficits during the procedure and/or in the 4 months follow-up
4 months
Secondary Outcomes (1)
Improvement of pulmonary deficits
1 year
Study Arms (1)
Autologous cell transplantation
EXPERIMENTALWe conducted a prospective, non-randomized, single-center longitudinal study in five patients. Inclusion criteria were age 18-50 years, chronic and accelerated silicosis, forced expiratory volume in 1s \<60% and \>40%, forced vital capacity ≥60% and arterial oxygen saturation \>90%. BMDMCs were administered through bronchoscopy (2×107 cells) into both lungs. Physical examination, laboratory evaluations, quality of life questionnaires, thoracic computed tomography scans, lung function tests, and perfusion scintigraphy were performed before the beginning of treatment and up to 360 days after BMDMC (Bone Marrow Derived Mononuclear Cells) therapy. Additionally, whole-body and planar scans were evaluated 2 and 24 h after instillation.
Interventions
Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Federal do Rio de Janeirolead
- Ministry of Science and Technology, Brazilcollaborator
- Ministry of Health, Brazilcollaborator
- National Research Council, Brazilcollaborator
Study Sites (1)
Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21949900, Brazil
Related Publications (1)
Morales MM, Souza SA, Loivos LP, Lima MA, Szklo A, Vairo L, Brunswick TH, Gutfilen B, Lopes-Pacheco M, Araujo AJ, Cardoso AP, Goldenberg RC, Rocco PR, Fonseca LM, Lapa e Silva JR. Pilot safety study of intrabronchial instillation of bone marrow-derived mononuclear cells in patients with silicosis. BMC Pulm Med. 2015 Jun 11;15:66. doi: 10.1186/s12890-015-0061-8.
PMID: 26059242DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 10, 2010
First Posted
November 11, 2010
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Study Completion
December 1, 2013
Last Updated
May 27, 2015
Record last verified: 2015-05