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Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease (COPD-01)

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ClinicalTrials.gov Identifier: NCT01110252
Recruitment Status : Completed
First Posted : April 26, 2010
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Collaborators:
Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
Instituto de Molestias Cardiovasculares
Information provided by (Responsible Party):
João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Obstructive Pulmonary Disease
Pulmonary Emphysema
Interventions Drug: Stem cells stimulation
Procedure: stem cells collection
Genetic: stem cells infusion
Enrollment 4
Recruitment Details From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled
Pre-assignment Details Patients signed the Knowledge and Free Consent Instrument (TCLE)
Arm/Group Title Prior Then Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description emphysema patients evaluated prior or after the infusion of the autologous stem cells
Period Title: Pre-procedure (Stem Cells Infusion)
Started 4
Completed 4
Not Completed 0
Period Title: Post-procedure (Stem Cells Infusion)
Started 4
Completed 4
Not Completed 0
Arm/Group Title Prior Then Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description emphysema patients evaluated prior or after the infusion of the autologous stem cells
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
65.75  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 4 participants
4
1.Primary Outcome
Title Forced Vital Capacity (FVC)
Hide Description A pulmonary function test that measures the volume and speed of the inhalated air.
Time Frame baseline and 30 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
all patients were evaluated prior and after the procedure
Arm/Group Title Prior to the Procedure (Stem Cells Infusion) Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description:
emphysema patients evaluated prior to the infusion of autologous stem cells
emphysema patients evaluated 30 days after the infusion of autologous stem cells
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: liters
1.5  (0.2) 2.1  (0.2)
2.Primary Outcome
Title Forced Expiratory Volume (FEV1)
Hide Description A pulmonary function test that measures the volume and speed of the exhaled air.
Time Frame baseline and 30 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
all patients were evaluated prior and after the procedure
Arm/Group Title Prior to the Procedure (Stem Cells Infusion) Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description:
emphysema patients evaluated prior to the infusion of autologous stem cells
emphysema patients evaluated 30 days after the infusion of autologous stem cells
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: liters
0.7  (0.1) 0.8  (0.1)
3.Primary Outcome
Title Vital Capacity - VC
Hide Description A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
Time Frame baseline and 30 days after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
all patients were evaluated prior and after the procedure.
Arm/Group Title Prior to the Procedure (Stem Cells Infusion) Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description:
emphysema patients evaluated prior to the infusion of autologous stem cells
emphysema patients evaluated 30 days after the infusion of autologous stem cells
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: liters
1.8  (0.3) 1.4  (0.3)
4.Secondary Outcome
Title Arterial Blood Gases Test - Pa O2
Hide Description presence of oxygen in the blood gases.
Time Frame baseline and 30 days after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
all patients were evaluated prior and after the procedure.
Arm/Group Title Prior to the Procedure (Stem Cells Infusion) Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description:
emphysema patients evaluated prior to the infusion of autologous stem cells
emphysema patients evaluated 30 days after the infusion of autologous stem cells
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: mmHg
69  (3) 57  (3)
5.Secondary Outcome
Title Arterial Blood Gases Test - Pa CO2
Hide Description presence of CO2 in the arterial blood.
Time Frame baseline and 30 days after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
all patients were evaluated prior and after the procedure
Arm/Group Title Prior to the Procedure (Stem Cells Infusion) Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description:
emphysema patients evaluated prior to the infusion of autologous stem cells
emphysema patients evaluated 30 days after the infusion of autologous stem cells
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: mm Hg
48.75  (2.7) 89.25  (2.7)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prior Then Post Procedure (Stem Cells Infusion)
Hide Arm/Group Description emphysema patients evaluated prior or after the infusion of the autologous stem cells
All-Cause Mortality
Prior Then Post Procedure (Stem Cells Infusion)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Prior Then Post Procedure (Stem Cells Infusion)
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prior Then Post Procedure (Stem Cells Infusion)
Affected / at Risk (%)
Total   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: João Tadeu Ribeiro Paes
Organization: Labcel
Phone: 55 18 3302 5800 ext 5856
Responsible Party: João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01110252     History of Changes
Other Study ID Numbers: upeclin/ASSIS Unesp - 001
First Submitted: April 20, 2010
First Posted: April 26, 2010
Results First Submitted: November 3, 2011
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012