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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Arda Kiani, MD,PULMONO contact

0098-021-27122171

Kiani@nritld.ac.ir

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

Other trials in Iran

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 groups in NCT01758055
Study groupRoleWhat they receive
Autologous MSCs transplantationExperimentalintra 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.

  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.

    Measured: Baseline and one year after procedure

Secondary outcomes (1)
  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.

  1. First posted31 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionJan 2014 (estimated)

Resources

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)
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

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.

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