Safety of Stem Cells Intrabronchial Instillation for Silicosis

Chronic and Accelerated Silicosis Clinical Trial

— SilicStemCell  

Official title:

Phase-1 Study of Autologous Bone Marrow Cells Intrabronchial Instillation for Patients Silicosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239862
• Other study ID #: CONEP5772008
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2010
• Last updated: May 26, 2015
• Start date: August 2009
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic and Accelerated Silicosis
• Silicosis

Intervention

Other:
• Autologous cell transplantation
Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells

Locations

Country	Name	City	State
Brazil	Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Ministry of Health, Brazil, Ministry of Science and Technology, Brazil, National Research Council, Brazil

Country where clinical trial is conducted

Brazil, 

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	Improvement of pulmonary deficits		1 year	Yes