Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients

Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema

The purpose of this study is evaluating the safety of endobronchial transplantation of autologous mesenchymal stem cells derived bone marrow in patients with emphysema.

Study Overview

• Status: Unknown
• Conditions: Emphysema
• Intervention / Treatment: Biological: Autologous MSCs transplantation

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a worldwide epidemic disease that the global prevalence of it was estimated to be approximately 210 million individuals and accounting for more than three million deaths annually. And currently, it is the fifth chief cause of death in the United State of America. COPD is characterized by chronic, irreversible inflammation of the airways and has two pathologic features, emphysema and bronchiolitis.

The most relevant feature in the lung emphysema is airflow limitation, resulting from the loss of alveolar wall and enlargement of alveolar space distal to the terminal bronchiole. Cigarette and air pollution are the most major factors for developing COPD. Unfortunately, aside from supplemental domiciliary oxygen for the small number of patients who demonstrate resting arterial hypoxemia and smoking cessation for continued smokers, there are no interventions that have been unequivocally shown to prolong survival in patients with COPD. In the preprocessing phase, patients will underwent a complete evaluation of the pulmonary function test with spirometer to measure the FEV1, FVC, FEV1/FVC, cardiac evaluation (clinical examination, six minute walk test, echocardiography TTE(transthoracic echocardiography ), and electrocardiography),chest X-ray, chest computed tomography scan (helical/high resolution),o2 saturation by oximeter, as well as routine laboratory tests (blood gas, urinalysis, coagulation, complete blood count (CBC), blood urea nitrogen, fasting glucose, creatinine, AST(aspartate aminotransferase), ALT(alanine aminotransferase), C-reactive protein, serology for hepatitis B and C, antihuman immunodeficiency virus, and treponemal test for syphilis (FTA-ABS)). The Dyspnea Scale Score test, modified according to the British MMRC, was also conducted, according to Mahler and Wells and Curley.And quality of life measures will assess according to SF-36(Medical Outcomes Study 36-Items Short-Form Health Survey) questioner.

Patients will taken to the operating room, placed in a prone position, and administer a spinal anesthesia. Approximately, 120 mL of bone marrow will aspirated from each puncture and after preparation about 60 million autologous MSCs will transplant by bronchoscopy into the endobronchial of these patients.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ARDA KIANI, MD,PULMONO; Phone Number: 0098-021-27122171; Email: KIANI@NRITLD.AC.IR
• Study Contact Backup: Name: Naser Aghdami, MD, PHD; Phone Number: 0098-021-22172330; Email: nasser.aghdami@royaninstitute.org

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 021
    • Masih-Daneshvari Hospital
    • Principal Investigator: Hoda Madani, MD
    • Contact: ARDA KIANI, MD,PULMONO; Phone Number: 0098-021-27122171; Email: KIANI@NRITLD.AC.IR
    • Contact: PARITASH TAHMASEB POUR, MD; Phone Number: 0098-09125037861; Email: PARITASH_T@YAHOO.COM
    • Principal Investigator: Paritash Tahmaseb pour, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Inclusion criteria were as follows:

  • patients with moderate to severe emphysema that has a FEV1≤50% (approved by HRCT)
  • aged less than 70 years
  • no tobacco use for at least 12 months before the protocol application
  • no serious coronaropathy and/or ventricular dysfunction
  • no significant renal illness and/or hepatitis
  • EF(ejection fraction)>50%
  • Creatinine < 2
  • AST, ALT≤ 10 times of its normal basis

Exclusion Criteria:

• Exclusion criteria were as follows:

  • detected immunosuppressive illnesses
  • carrier of known neoplasias
  • pregnancy
  • limitation in daily physical activities
  • known case of diabetic disorders
  • modifying in his/her medical treatment regime in the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous MSCs transplantation; intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once	Biological: Autologous MSCs transplantation; Autologous mesenchymal stem cells derived bone marrow, bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC	A pulmonary function test that measures the volume and speed of inhaled air.; A pulmonary function test that measures the volume and speed of exhaled air.	Baseline and one year after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
six minute walk test	•A six minute walk test with treadmills	Baseline and One year after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen saturation	•An oximeter test for evaluating the oxygen saturation	Baseline and one year after procedure
Quality of life	•A SF36 quality of life questioner for evaluating the quality of life	Baseline and One year after procedure
DLCO(diffusion capacity of lung for carbon monoxide)	•Body Box device for evaluating diffusing capacity of the lung for carbon monoxide	Baseline and One year after procedure
CT scan	•A CT scan for evaluating the changes	Baseline and One year after procedure
dyspnea score	•A MMRC(modified medical research council) scale for evaluating the dyspnea score	Baseline and One year after procedure
Atrial blood gases test-PaO2(partial pressure of oxygen in blood) , PaCO2(partial pressure of carbon dioxide in blood)	presence of oxygen in blood gases; presence of carbon dioxide in blood gases	Baseline and one year after procedure
Infection	•A CBC test for evaluating the infection	Baseline and one year after procedure

Collaborators and Investigators

• Sponsor: Arda Kiani
• Collaborators: Royan Institute
• Investigators: Study Director: Arda Kiani, MD, pulmono, Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.; Study Director: Naser Aghdami, MD,PHD, Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: November 18, 2012
• First Submitted That Met QC Criteria: December 23, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): December 31, 2012
• Last Update Submitted That Met QC Criteria: December 23, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Mesenchymal stem cell, emphysema, lung function
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: f-91-135