Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

NCT01110252 | Completed Results

• 1 other identifier: upeclin/ASSIS Unesp - 001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Obstructive Pulmonary Disease; Emphysema; Cell therapy; Bone marrow mononuclear cells; stem cells

Outcome Measures

Primary Outcomes (3)

• Forced Vital Capacity (FVC)

  A pulmonary function test that measures the volume and speed of the inhalated air.

  baseline and 30 days after procedure

• Forced Expiratory Volume (FEV1)

  A pulmonary function test that measures the volume and speed of the exhaled air.

  baseline and 30 days after procedure

• Vital Capacity - VC

  A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.

  baseline and 30 days after the procedure

Secondary Outcomes (2)

• Arterial Blood Gases Test - Pa O2

  baseline and 30 days after procedure

• Arterial Blood Gases Test - Pa CO2

  baseline and 30 days after the procedure

Study Arms (2)

pre-procedure

ACTIVE COMPARATOR

emphysema patients evaluated prior to the stem cells infusion

Drug: Stem cells stimulation; Procedure: stem cells collection; Genetic: stem cells infusion

post-procedure

EXPERIMENTAL

emphysema patients evaluated 30 days after the stem cells infusion

Drug: Stem cells stimulation; Procedure: stem cells collection; Genetic: stem cells infusion

Interventions

Stem cells stimulation DRUG

Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.

Also known as: Filgrastin - ACHÉ Laboratories.

post-procedure; pre-procedure

stem cells collection PROCEDURE

pullout of 200ml of bone marrow through the puncture of the iliac crest

Also known as: bone marrow harvest

post-procedure; pre-procedure

stem cells infusion GENETIC

slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.

Also known as: adult stem cell infusion

post-procedure; pre-procedure

Eligibility Criteria

• Age: 40 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of severe chronic obstructive pulmonary disease
• ineffective clinical treatment
• limited life expectancy
• limitations in daily physical activity
• possibility of pulmonary rehabilitation physiotherapy
• acceptable nutritional status
• acceptable cardiac function
• at least six months smoking cessation
• family support
• modified medical research council dyspnea scale stage \> 3

You may not qualify if:

• pulmonary or extra-pulmonary infection
• severe coronary disease and/or ventricular dysfunction
• significant kidney or liver disease
• immunosuppressive disease
• active smoker
• cancer
• psychosocial problems
• established medical protocol
• family rejection
• pregnancy

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Laboratório de Genética Humana e Terapia Celular, Unesp - Assis: collaborator
• Instituto de Molestias Cardiovasculares: collaborator

Study Sites (1)

Laboratório de Genética Humana e Terapia Celular

Assis, São Paulo, 19.806-900, Brazil

Location

Related Publications (2)

• Ribeiro-Paes JT, Stessuk T, Marcelino M, Faria C, Marinelli T, Ribeiro-Paes MJ. A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease. Rev Port Pneumol. 2014 Mar-Apr;20(2):84-91. doi: 10.1016/j.rppneu.2013.06.008. Epub 2013 Nov 26. English, Portuguese.

  PMID: 24287082 DERIVED

• Ribeiro-Paes JT, Bilaqui A, Greco OT, Ruiz MA, Marcelino MY, Stessuk T, de Faria CA, Lago MR. Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema. Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:63-71. doi: 10.2147/COPD.S15292.

  PMID: 21311694 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

small number of subjects analyzed

Results Point of Contact

• Title: João Tadeu Ribeiro Paes
• Organization: Labcel

labcel.tronco@gmail.com

55 18 3302 5800

Study Officials

• João T Ribeiro-Paes, PhD MD

  geneticist

  PRINCIPAL INVESTIGATOR

• Aldemir Bilaqui, MD

  surgeon

  STUDY DIRECTOR

• Oswaldo T Greco, MD

  cardiologist

  STUDY CHAIR

• Milton A Ruiz, MD

  hematologist

  STUDY CHAIR

• José D Araújo, MD

  surgeon

  STUDY CHAIR

• Mario R Lago, Ms

  technician

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sponsor

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 26, 2010
• Study Start: May 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2011
• Last Updated: March 26, 2012
• Results First Posted: March 26, 2012

Record last verified: 2012-02

Locations

BR (1)