Trial Outcomes & Findings for Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease (NCT NCT01110252)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

baseline and 30 days after procedure

Results posted on

2012-03-26

Participant Flow

From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled

Patients signed the Knowledge and Free Consent Instrument (TCLE)

Participant milestones

Participant milestones
Measure	Prior Then Post Procedure (Stem Cells Infusion) emphysema patients evaluated prior or after the infusion of the autologous stem cells
Pre-procedure (Stem Cells Infusion) STARTED	4
Pre-procedure (Stem Cells Infusion) COMPLETED	4
Pre-procedure (Stem Cells Infusion) NOT COMPLETED	0
Post-procedure (Stem Cells Infusion) STARTED	4
Post-procedure (Stem Cells Infusion) COMPLETED	4
Post-procedure (Stem Cells Infusion) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prior Then Post Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated prior or after the infusion of the autologous stem cells
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age Continuous	65.75 years STANDARD_DEVIATION 1 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Region of Enrollment Brazil	4 participants n=99 Participants

PRIMARY outcome

Timeframe: baseline and 30 days after procedure

Population: all patients were evaluated prior and after the procedure

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

Outcome measures

Outcome measures
Measure	Prior to the Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated prior to the infusion of autologous stem cells	Post Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated 30 days after the infusion of autologous stem cells
Forced Vital Capacity (FVC)	1.5 liters Standard Deviation 0.2	2.1 liters Standard Deviation 0.2

PRIMARY outcome

Timeframe: baseline and 30 days after procedure

Population: all patients were evaluated prior and after the procedure

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

Outcome measures

Outcome measures
Measure	Prior to the Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated prior to the infusion of autologous stem cells	Post Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated 30 days after the infusion of autologous stem cells
Forced Expiratory Volume (FEV1)	0.7 liters Standard Deviation 0.1	0.8 liters Standard Deviation 0.1

PRIMARY outcome

Timeframe: baseline and 30 days after the procedure

Population: all patients were evaluated prior and after the procedure.

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

Outcome measures

Outcome measures
Measure	Prior to the Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated prior to the infusion of autologous stem cells	Post Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated 30 days after the infusion of autologous stem cells
Vital Capacity - VC	1.8 liters Standard Deviation 0.3	1.4 liters Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline and 30 days after procedure

Population: all patients were evaluated prior and after the procedure.

presence of oxygen in the blood gases.

Outcome measures

Outcome measures
Measure	Prior to the Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated prior to the infusion of autologous stem cells	Post Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated 30 days after the infusion of autologous stem cells
Arterial Blood Gases Test - Pa O2	69 mmHg Standard Deviation 3	57 mmHg Standard Deviation 3

SECONDARY outcome

Timeframe: baseline and 30 days after the procedure

Population: all patients were evaluated prior and after the procedure

presence of CO2 in the arterial blood.

Outcome measures

Outcome measures
Measure	Prior to the Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated prior to the infusion of autologous stem cells	Post Procedure (Stem Cells Infusion) n=4 Participants emphysema patients evaluated 30 days after the infusion of autologous stem cells
Arterial Blood Gases Test - Pa CO2	48.75 mm Hg Standard Deviation 2.7	89.25 mm Hg Standard Deviation 2.7

Adverse Events

Prior Then Post Procedure (Stem Cells Infusion)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

João Tadeu Ribeiro Paes

Labcel

Phone: 55 18 3302 5800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place