Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
NCT01110252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2012-03-26
Summary
The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.
Conditions
- Chronic Obstructive Pulmonary Disease
- Pulmonary Emphysema
Interventions
- DRUG
-
Stem cells stimulation
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
- PROCEDURE
-
stem cells collection
pullout of 200ml of bone marrow through the puncture of the iliac crest
- GENETIC
-
stem cells infusion
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
Sponsors & Collaborators
-
Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
collaborator UNKNOWN -
Instituto de Molestias Cardiovasculares
collaborator OTHER -
UPECLIN HC FM Botucatu Unesp
lead OTHER
Principal Investigators
-
João T Ribeiro-Paes, PhD MD · geneticist
-
Aldemir Bilaqui, MD · surgeon
-
Oswaldo T Greco, MD · cardiologist
-
Milton A Ruiz, MD · hematologist
-
José D Araújo, MD · surgeon
-
Mario R Lago, Ms · technician
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 72 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2010-10-31
- Completion
- 2011-11-30
Countries
- Brazil
Study Locations
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