Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 31, 2012
November 1, 2012
1 year
November 18, 2012
December 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
six minute walk test
Baseline and One year after procedure
Other Outcomes (7)
oxygen saturation
Baseline and one year after procedure
Quality of life
Baseline and One year after procedure
DLCO(diffusion capacity of lung for carbon monoxide)
Baseline and One year after procedure
- +4 more other outcomes
Study Arms (1)
Autologous MSCs transplantation
EXPERIMENTALintra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once
Interventions
Autologous mesenchymal stem cells derived bone marrow, bronchoscopy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arda Kianilead
- Royan Institutecollaborator
Study Sites (1)
Masih-Daneshvari Hospital
Tehran, Tehran Province, 021, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Shahid Beheshti University
Study Record Dates
First Submitted
November 18, 2012
First Posted
December 31, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
December 31, 2012
Record last verified: 2012-11