EmphysemaPhase 1NCT01758055
Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients
A Phase 1 study testing Autologous MSCs transplantation in people with Emphysema, run by Arda Kiani at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Emphysema
- What is being tested?
- Autologous MSCs transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIran
- Study dates
- Dec 2012to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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
Show all 9Show fewer
- EF(ejection fraction)>50%
- Creatinine < 2
- AST, ALT≤ 10 times of its normal basis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Masih-Daneshvari Hospital
Tehran, Tehran Province, 021
ARDA KIANI, MD,PULMONO, 0098-021-27122171, KIANI@NRITLD.AC.IR
PARITASH TAHMASEB POUR, MD, 0098-09125037861, PARITASH_T@YAHOO.COM
About this study
Official title: 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.
Read the 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
- Being tested
- Autologous MSCs transplantation
- Keywords
- Mesenchymal stem cell, emphysema, lung function
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous MSCs transplantationBiological
Autologous mesenchymal stem cells derived bone marrow, bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Autologous MSCs transplantation | Experimental | intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once Receives: Biological: Autologous MSCs transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and one year after procedure
Secondary outcomes (1)
six minute walk test
•A six minute walk test with treadmills
Measured: Baseline and One year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arda Kiani
- Sponsor type
- University, hospital or other
- Collaborators
- Royan Institute
- Responsible party
- Sponsor-investigator, Arda Kiani, Masih Daneshvari Hospital
- Investigators
- Arda Kiani, MD, pulmono, Study director, Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.Naser Aghdami, MD,PHD, Study director, Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758055
- Sponsor's protocol ID
- f-91-135
- Status last verified
- Nov 2012
- First submitted
- 18 Nov 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema
- ClinicalTrials.gov ID
- NCT01758055
- Acronym / sponsor ID
- f-91-135
- Conditions
- Emphysema
- Keywords
- Mesenchymal stem cell, emphysema, lung function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Arda KianiUniversity, hospital or other
- Collaborators
- Royan Institute
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous MSCs transplantation | Experimental | Biological: Autologous MSCs transplantationintra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- • Inclusion criteria were as follows:
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous MSCs transplantationAutologous mesenchymal stem cells derived bone marrow, bronchoscopy | Biological | Autologous MSCs transplantation |
Primary outcome
forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC
Time frame: Baseline and one year after procedure
* 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.
1 secondary outcome
six minute walk test
Time frame: Baseline and One year after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arda Kiani, MD, pulmono study director
Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Naser Aghdami, MD,PHD study director
Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous MSCs transplantation in people with Emphysema, run by Arda Kiani at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arda Kiani, MD,PULMONO (0098-021-27122171, Kiani@nritld.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC (time frame: Baseline and one year after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2012.