Safety of Stem Cells Intrabronchial Instillation for Silicosis

NCT ID: NCT01239862

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Chronic and Accelerated Silicosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous cell transplantation

We 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.

Group Type: EXPERIMENTAL

Autologous cell transplantation

Intervention Type: OTHER

Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells

Interventions

Autologous cell transplantation

Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Brazil

OTHER

Sponsor Role: collaborator

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

National Research Council, Brazil

OTHER

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Marcos Morales

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 26059242 (View on PubMed)

Other Identifiers

CONEP5772008

Identifier Type: -

Identifier Source: org_study_id