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

NCT ID: NCT01758055

Last Updated: 2012-12-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-01-31

Brief Summary

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

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.

Conditions

Emphysema

Keywords

Mesenchymal stem cell, emphysema, lung function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous MSCs transplantation

intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once

Group Type: EXPERIMENTAL

Autologous MSCs transplantation

Intervention Type: BIOLOGICAL

Autologous mesenchymal stem cells derived bone marrow, bronchoscopy

Interventions

Autologous MSCs transplantation

Autologous mesenchymal stem cells derived bone marrow, bronchoscopy

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: collaborator

Arda Kiani

OTHER

Sponsor Role: lead

Responsible Party

Arda Kiani

Professor of Shahid Beheshti University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arda Kiani, MD, pulmono

Role: STUDY_DIRECTOR

Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Naser Aghdami, MD,PHD

Role: STUDY_DIRECTOR

Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran

Locations

Masih-Daneshvari Hospital

Tehran, Tehran Province, Iran

Countries

Iran

Central Contacts

Arda Kiani, MD,PULMONO

Role: CONTACT

Phone: 0098-021-27122171

Email: Kiani@nritld.ac.ir

Naser Aghdami, MD, PHD

Role: CONTACT

Phone: 0098-021-22172330

Email: nasser.aghdami@royaninstitute.org

Facility Contacts

ARDA KIANI, MD,PULMONO

Role: primary

PARITASH TAHMASEB POUR, MD

Role: backup

Other Identifiers

f-91-135

Identifier Type: -

Identifier Source: org_study_id