Safety of Stem Cells Intrabronchial Instillation for Silicosis (SilicStemCell)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Universidade Federal do Rio de Janeiro.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Brazil, Ministery of Science and Technology
Ministry of Health, Brazil
National Research Council, Brazil
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01239862
First received: November 10, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic and Accelerated Silicosis, Characterized With a Fibrotic Increase in the Last Two Years
Other: Autologous cell transplantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase-1 Study of Autologous Bone Marrow Cells Intrabronchial Instillation for Patients Silicosis

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

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:
  • Improvement of pulmonary deficits [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Autologous cell transplantation
    Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells
Detailed Description:

This study will perfume the safety (Phase I) study of 10 patients with silicosis treated with intrabronchial instillation of autologous bone marrow derived mononuclear cells (BMDMC, 2x107) through bronchoscopy. The inclusion criteria is: age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 <60% and > 40%, FVC > 60% and SaO2 >90%, while the exclusion criteria were: smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy. All patients will be subjected to clinical examination, answered questionnaires of quality of life (SGRQ and SF36) and dyspnea score (Borg), performed high resolution CT of thorax, pulmonary function tests with DLCO and 6-minute walk test and lung perfusion scintigraphy before and 7, 30, 60, 180 and 360 days after treatment.

For each patient, 2×107 cells will be labeled with 99mTc. Briefly, 500 μl of sterile SnCl2 solution is added to the cells and the mixture is incubated at room temperature for 10 min. Forty-five mCi of 99mTc is then added and incubation continued for another 10 min. After centrifugation (500×g for 5 min), the supernatant is removed and the cells are washed in saline solution. The pellet was also resuspended in saline solution. Viability of the labeled cells was assessed by the trypan blue exclusion test, and was estimated to be greater than 93% in all cases. Labeling efficiency (%) was calculated by the activity in the pellet divided by the sum of the radioactivity in the pellet plus supernatant and was estimated to be greater than 90% in all cases. Whole body and planar scans will be performed 2 and 24h after instillation. Perfusion scintigraphy will be performed before and 30, 60, 120 and 180 days after BMDMC therapy. For regional analysis the right and left lungs will be divided into three zones: base, midzone, and apex.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 <60% and > 40%, FVC > 60% and SaO2 >90%

Exclusion Criteria: smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and 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: NCT01239862

Contacts
Contact: Jose Roberto Lapa Silva, MD, PhD 552125626722
Contact: Marcelo Marcos Morales, MD PhD 552125626572

Locations
Brazil
Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro Recruiting
Rio de Janeiro, RJ, Brazil, 21949900
Contact: Jose Roberto Lapa Silva, MD, PhD    552125626722    jrlapa.ntg@terra.com.br   
Contact: Marcelo Marcos Morales, MD, PhD    552125626572    mmorales@biof.ufrj.br   
Principal Investigator: Marcelo Marcos Morales, MD, PHD         
Principal Investigator: Jose Roberto Lapa Silva, MD, PhD         
Sub-Investigator: Patricia Reiken Rocco, MD, PhD         
Sub-Investigator: Lea Miriam Barbosa da Fonseca, MD, PhD         
Sub-Investigator: Luiz Paulo Loivos, MD, Phd         
Sub-Investigator: Marina Andrade Lima, MD, PhD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Brazil, Ministery of Science and Technology
Ministry of Health, Brazil
National Research Council, Brazil
  More Information

No publications provided

Responsible Party: Dr. José Roberto Lapa Silva, Dr. Marcelo Marcos Morales
ClinicalTrials.gov Identifier: NCT01239862     History of Changes
Other Study ID Numbers: CONEP5772008
Study First Received: November 10, 2010
Last Updated: November 10, 2010
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

Keywords provided by Universidade Federal do Rio de Janeiro:
pulmonary, silicosis, chronic and accelerated silicosis, autologous transplantation
bone marrow cells, stem cells, cell therapy

Additional relevant MeSH terms:
Silicosis
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases

ClinicalTrials.gov processed this record on August 28, 2014