NCT02412332

Brief Summary

The purpose of this study is to determine whether cell therapy with autologous adult stem cells (from bone marrow and/or fat) is safe in the treatment of advanced Chronic Obstructive Pulmonary Disease (COPD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

March 24, 2015

Last Update Submit

May 21, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

advanced COPD (stage III)Adult stem cellsCell therapy

Outcome Measures

Primary Outcomes (1)

  • Total Pulmonary Capacity

    Assessed by whole body plethysmography, measured in liters.

    12 months after procedure

Secondary Outcomes (2)

  • Pulmonary morphology

    9 months after procedure

  • Pulmonary function

    12 months after procedure

Study Arms (4)

Group 1 - Control

NO INTERVENTION

The patients will be followed during the course of 12 months and evaluated regarding disease progression. No interventions will be performed other than conventional (in-course) treatment.

Group 2 - BMMC

EXPERIMENTAL

Patients will be submitted to bone marrow harvesting. Bone marrow mononuclear cells (BMMC) will be obtained by Ficoll separation and returned to patients by systemic infusion (1x10\^8 BMMC in 30 mL saline). Three patients will be submitted to Lung perfusion scintigraphy with technetium for cell engraftment evaluation.

Procedure: Bone marrow harvesting

Group 3 - ASC

EXPERIMENTAL

Patients will be submitted to liposuction. The obtained fat tissue will be cultivated by 21 days and adipose-derived stem cell (ASC) will be returned to patients by systemic infusion (1x10\^8 ASC in 30 mL saline). Three patients will be submitted to Lung perfusion scintigraphy with technetium for cell engraftment evaluation.

Procedure: Liposuction

Group 4 - BMMC + ASC

EXPERIMENTAL

Patients will be submitted to liposuction and the obtained fat tissue will be cultivated by 21 days and adipose-derived stem cell (ASC) obtained. Patients will be submitted to bone marrow harvesting and bone marrow mononuclear cells (BMMC) will be obtained by Ficoll separation. BMMC and ASC will be returned to patients by systemic infusion (5x10\^7 ASC + 5x10\^7 BMMC in 30 mL saline). Three patients will be submitted to Lung perfusion scintigraphy with technetium for cell engraftment evaluation.

Procedure: Bone marrow harvestingProcedure: Liposuction

Interventions

Bone marrow harvestingPROCEDURE

Approximately 200 mL of bone marrow will be surgically collect from the iliac crest (pelvis) of the patient under spinal anesthesia.

Group 2 - BMMCGroup 4 - BMMC + ASC
LiposuctionPROCEDURE

Approximately 50 mL of adipose tissue (fat) will be surgically collected from the abdominal region of the patient under spinal anesthesia.

Group 3 - ASCGroup 4 - BMMC + ASC

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients with persistent dyspnea in stage 2 or 3 of the dyspnea scale score;
  • Eligibility for pulmonary rehabilitation program;
  • No smoking or smoking cessation for at least 6 months.

You may not qualify if:

  • Absence of emphysema on chest tomography;
  • Pulmonary or extrapulmonary infection or active infection history in less than 3 months;
  • History of coronary artery disease and/or severe ventricular dysfunction (ejection fraction \<55%);
  • Presence of pulmonary hypertension, ie, estimated systolic pulmonary artery pressure above 35 mmHg at transthoracic Doppler echocardiography;
  • Patients in home oxygen therapy;
  • Advanced renal failure (serum creatinine greater than 1.5 mg / dL) and liver failure CHILD B or C;
  • Immunosuppressive or infectious diseases detected;
  • Patients with known malignancies or collagen diseases;
  • Psycho-social problems, drug and/or alcohol abuse and not obedient to the established medical protocol;
  • No family acceptance;
  • Pregnancy or at risk of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Genética e Terapia Celular - GenTe Cel

Assis, São Paulo, 19.806-900, Brazil

Location

Related Publications (3)

  • Stessuk T, Ruiz MA, Greco OT, Bilaqui A, Ribeiro-Paes MJ, Ribeiro-Paes JT. Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years. Rev Bras Hematol Hemoter. 2013;35(5):352-7. doi: 10.5581/1516-8484.20130113.

    PMID: 24255620BACKGROUND

  • 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: 21311694BACKGROUND

  • 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: 24287082BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Selma D Squassoni, MD

    Faculdade de Medicina do ABC

    STUDY CHAIR

  • Ellie Fiss, MD

    Faculdade de Medicina do ABC

    STUDY CHAIR

  • Elíseo J Sekya

    IEP São Lucas - Instituto de Ensino e Pesquisa

    STUDY CHAIR

  • Adelson Alves, Dr

    Hemocentro São Lucas

    STUDY CHAIR

  • Andressa Forte

    TechLife

    STUDY CHAIR

  • Larissa C Zanutto

    IEP São Lucas - Instituto de Ensino e Pesquisa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

BR(1)