BronchiectasisPhase 1CELEBNCT02625246
Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis Bronchiectasis
A Phase 1 study testing hMSCs in people with Bronchiectasis, run by Marilyn Glassberg at 1 site in United States.
Trial summary
To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore treatment efficacy Read more about this study
- Who is it for?
- Ages 30 to 87 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- hMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2016to 15 May 2019
- 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 30 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent,
- be between 30 and 87 years old at the time of signing the Informed Consent,
- weight over 45 and under 150 kg,
- have a clinical diagnosis of non-CF bronchiectasis prior to screening,
- Have had at least 2 exacerbations in the past year as documented by physician office or hospital visits (Use of antibiotics of at least one time in the last year),
- Show a baseline FEV1 between 25% and 85% predicted and over or equal to 1 L and a baseline diffusion capacity of lung for carbon monoxide (DLCO) over or equal to 30% (corrected for hemoglobin but not alveolar volume),
Show all 10Show fewer
- Have a normal Right Ventricular function, as documented by Doppler echo or right heart catheterization,
- if a female of childbearing potential, agree to abide by contraception rules defined below.
- Subjects may receive nondrug therapies including oxygen supplementation not greater than 4 Liters per minute and pulmonary rehabilitation.
- Subjects may be on chronic macrolide or inhaled antibiotic treatment bronchiectasis
Who cannot join
- Have HRCT and or surgical lung biopsy results inconsistent with the diagnosis of non-CF bronchiectasis. (Exclusion of emphysema and or diffuse parenchymal disease)
- be unable to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform Pulmonary Function Tests (PFT) or HRCT, undergo blood draws, read and respond to questionnaire
- If a female of childbearing potential, have a follicle stimulating hormone (FSH) under 25.8 IU/L
- be actively treated for an acute infectious exacerbation of bronchiectasis
- Have an active infection that is not treated
- Have had active infections occurring within a minimum of 4 weeks of study treatment
Show all 21Show fewer
- Be currently on treatment for NTM infections
- Have had positive sputum cultures for nontuberculous mycobacterial (NTM) within the past 6 months
- Have a history of drug or alcohol abuse within the past 24 months.
- Be currently receiving (or have received within four weeks of screening) experimental agents for the treatment of bronchiectasis or have been enrolled in clinical trials within the previous 30 days
- Be actively listed (or expect future listing) for transplant of any organ.
- Have clinically important abnormal screening laboratory values.
- Have a serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
- Have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
- Have known allergies to penicillin or streptomycin.
- Be an organ transplant recipient.
- Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or cervical carcinoma.
- Have a non-pulmonary condition that limits lifespan to less than 1 year.
- Be serum positive for HIV, hepatitis BsAg (surface agent reactive) or Viremic hepatitis C.
- Have hypersensitivity to dimethyl sulfoxide (DMSO)
- Be unable to maintain saturated oxygen (SpO2) of more than 93% on room air at sea level at rest) or an SpO2 of more than 88% on room air over 5,000 feet (1524 meters) above sea level at rest.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Hospitals & Clinics
Miami, Florida, 33136
About this study
Official title: A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell (hMSC) Infusion in Patients With Non-Cystic Fibrosis Bronchiectasis
To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore treatment efficacy
Read the detailed description
A Phase 1 investigation will be performed to test the safety of two doses of bone-marrow derived hMSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.
Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 x106 (20 million) cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive a single administration of allogeneic hMSCs: 1 x108 (100 million) cells delivered via peripheral intravenous infusion Interim safety analysis will be performed four weeks after the 1st subject is enrolled in each cohort. Continued safety and tolerability with review of adverse events (AEs) will be assessed at each visit. Efficacy parameters (pulmonary function tests, lung diffusion capacity, lung volumes, 6-Minute Walk Test (6MWT), and dyspnea/Quality of Life (QOL) questionnaires) will be assessed every 12 weeks until study completion. Clinical laboratory tests to assess safety will be performed at every visit.
High Resolution Computed Tomography (HRCT) scan will be performed at the baseline visit (if not done within three months prior to enrollment) and then at week 24.
- Conditions
- Bronchiectasis
- Being tested
- hMSCs
- Keywords
- bronchiectasis, mesenchymal stem cell, lung, pulmonary, interstitial lung disease
- Medical subject headings
- Bronchiectasis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMSCsBiological
Also called allogeneic mesenchymal stem cell
intravenous infusion of bone marrow-derived allogeneic stem cells
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 3 patients will receive a single administration of allogeneic hMSCs: 20 x106 (20 million) cells delivered via peripheral intravenous infusion Receives: Biological: hMSCs |
| Group 2 | Experimental | 3 patients will receive a single administration of allogeneic hMSCs: 1 x108 (100 million) cells delivered via peripheral intravenous infusion Receives: Biological: hMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant with treatment emergent serious adverse events
incidence of any treatment-emergent serious adverse events defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities
Measured: Week 4 post infusion
Secondary outcomes (5)
Difference in Colony Forming Units (CFUs) in semiquantitative culture of sputum
Difference in CFUs in semiquantitative culture of sputum
Measured: Participants will be followed from 1 week to an expected average of 24 weeks following infusion.
rate of decline of lung function
difference in absolute decline of forced expiratory volume at one second (FEV1) percent predicted
Measured: Participants will be followed from 12 weeks to an expected average of 24 weeks following infusion.
frequency of acute exacerbations
increased cough and sputum production, fever, new or worsened dyspnea in less than 30 days, new or worsened hypoxemia in the absence of other identifiable causes
Measured: Participants will be followed from 12 weeks to an expected average of 48 weeks following infusion.
reported dyspnea and quality of life assessment
using quality of life tool questionnaire QOL-B version 2
Measured: Participants will be followed from 4 weeks to an expected average of 48 weeks following infusion.
death from any cause
death from any cause
Measured: Participants will be followed for the duration of the trial, which is an expected average of 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start4 Feb 2016
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marilyn Glassberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marilyn Glassberg, University of Miami
- Investigators
- Glassberg K Marilyn, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625246
- Sponsor's protocol ID
- 20150627
- Acronym
- CELEB
- Status last verified
- Aug 2019
- First submitted
- 4 Dec 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
King P. Pathogenesis of bronchiectasis. Paediatr Respir Rev. 2011 Jun;12(2):104-10. doi: 10.1016/j.prrv.2010.10.011. Epub 2010 Nov 24.
PubMed 21458738Weycker D, Edelsberg J, Oster G, Tino G. Prevalence and economic burden of bronchiectasis. Clin Pulm Med. 2005;12(4):205-9
Seitz AE, Olivier KN, Adjemian J, Holland SM, Prevots DR. Trends in bronchiectasis among medicare beneficiaries in the United States, 2000 to 2007. Chest. 2012 Aug;142(2):432-439. doi: 10.1378/chest.11-2209.
PubMed 22302301Bilton D, Tino G, Barker AF, Chambers DC, De Soyza A, Dupont LJ, O'Dochartaigh C, van Haren EH, Vidal LO, Welte T, Fox HG, Wu J, Charlton B; B-305 Study Investigators. Inhaled mannitol for non-cystic fibrosis bronchiectasis: a randomised, controlled trial. Thorax. 2014 Dec;69(12):1073-9. doi: 10.1136/thoraxjnl-2014-205587. Epub 2014 Sep 21.
PubMed 25246664Quittner AL, O'Donnell AE, Salathe MA, Lewis SA, Li X, Montgomery AB, O'Riordan TG, Barker AF. Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Thorax. 2015 Jan;70(1):12-20. doi: 10.1136/thoraxjnl-2014-205918. Epub 2014 Oct 16.
PubMed 25323621Wong C, Jayaram L, Karalus N, Eaton T, Tong C, Hockey H, Milne D, Fergusson W, Tuffery C, Sexton P, Storey L, Ashton T. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):660-7. doi: 10.1016/S0140-6736(12)60953-2.
PubMed 22901887Rogers GB, Bruce KD, Martin ML, Burr LD, Serisier DJ. The effect of long-term macrolide treatment on respiratory microbiota composition in non-cystic fibrosis bronchiectasis: an analysis from the randomised, double-blind, placebo-controlled BLESS trial. Lancet Respir Med. 2014 Dec;2(12):988-96. doi: 10.1016/S2213-2600(14)70213-9. Epub 2014 Oct 14.
PubMed 25458200Altenburg J, de Graaff CS, Stienstra Y, Sloos JH, van Haren EH, Koppers RJ, van der Werf TS, Boersma WG. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013 Mar 27;309(12):1251-9. doi: 10.1001/jama.2013.1937.
PubMed 23532241Gupta N, Su X, Popov B, Lee JW, Serikov V, Matthay MA. Intrapulmonary delivery of bone marrow-derived mesenchymal stem cells improves survival and attenuates endotoxin-induced acute lung injury in mice. J Immunol. 2007 Aug 1;179(3):1855-63. doi: 10.4049/jimmunol.179.3.1855.
PubMed 17641052Lee JW, Fang X, Gupta N, Serikov V, Matthay MA. Allogeneic human mesenchymal stem cells for treatment of E. coli endotoxin-induced acute lung injury in the ex vivo perfused human lung. Proc Natl Acad Sci U S A. 2009 Sep 22;106(38):16357-62. doi: 10.1073/pnas.0907996106. Epub 2009 Aug 31.
PubMed 19721001Fang X, Neyrinck AP, Matthay MA, Lee JW. Allogeneic human mesenchymal stem cells restore epithelial protein permeability in cultured human alveolar type II cells by secretion of angiopoietin-1. J Biol Chem. 2010 Aug 20;285(34):26211-22. doi: 10.1074/jbc.M110.119917. Epub 2010 Jun 16.
PubMed 20554518Gupta N, Krasnodembskaya A, Kapetanaki M, Mouded M, Tan X, Serikov V, Matthay MA. Mesenchymal stem cells enhance survival and bacterial clearance in murine Escherichia coli pneumonia. Thorax. 2012 Jun;67(6):533-9. doi: 10.1136/thoraxjnl-2011-201176. Epub 2012 Jan 16.
PubMed 22250097Krasnodembskaya A, Samarani G, Song Y, Zhuo H, Su X, Lee JW, Gupta N, Petrini M, Matthay MA. Human mesenchymal stem cells reduce mortality and bacteremia in gram-negative sepsis in mice in part by enhancing the phagocytic activity of blood monocytes. Am J Physiol Lung Cell Mol Physiol. 2012 May 15;302(10):L1003-13. doi: 10.1152/ajplung.00180.2011. Epub 2012 Mar 16.
PubMed 22427530Krasnodembskaya A, Song Y, Fang X, Gupta N, Serikov V, Lee JW, Matthay MA. Antibacterial effect of human mesenchymal stem cells is mediated in part from secretion of the antimicrobial peptide LL-37. Stem Cells. 2010 Dec;28(12):2229-38. doi: 10.1002/stem.544.
PubMed 20945332Lee JW, Krasnodembskaya A, McKenna DH, Song Y, Abbott J, Matthay MA. Therapeutic effects of human mesenchymal stem cells in ex vivo human lungs injured with live bacteria. Am J Respir Crit Care Med. 2013 Apr 1;187(7):751-60. doi: 10.1164/rccm.201206-0990OC.
PubMed 23292883
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell (hMSC) Infusion in Patients With Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT02625246
- Acronym / sponsor ID
- CELEB / 20150627
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, mesenchymal stem cell, lung, pulmonary, interstitial lung disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Marilyn GlassbergUniversity, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 9 Dec 2015 (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.
To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore treatment efficacy
Detailed description
A Phase 1 investigation will be performed to test the safety of two doses of bone-marrow derived hMSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.
Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 x106 (20 million) cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive a single administration of allogeneic hMSCs: 1 x108 (100 million) cells delivered via peripheral intravenous infusion Interim safety analysis will be performed four weeks after the 1st subject is enrolled in each cohort. Continued safety and tolerability with review of adverse events (AEs) will be assessed at each visit. Efficacy parameters (pulmonary function tests, lung diffusion capacity, lung volumes, 6-Minute Walk Test (6MWT), and dyspnea/Quality of Life (QOL) questionnaires) will be assessed every 12 weeks until study completion. Clinical laboratory tests to assess safety will be performed at every visit.
High Resolution Computed Tomography (HRCT) scan will be performed at the baseline visit (if not done within three months prior to enrollment) and then at week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: hMSCs3 patients will receive a single administration of allogeneic hMSCs: 20 x106 (20 million) cells delivered via peripheral intravenous infusion |
| Group 2 | Experimental | Biological: hMSCs3 patients will receive a single administration of allogeneic hMSCs: 1 x108 (100 million) cells delivered via peripheral intravenous infusion |
Who may qualify
- Ages
- 30 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent,
- be between 30 and 87 years old at the time of signing the Informed Consent,
- weight over 45 and under 150 kg,
- have a clinical diagnosis of non-CF bronchiectasis prior to screening,
- Have had at least 2 exacerbations in the past year as documented by physician office or hospital visits (Use of antibiotics of at least one time in the last year),
Key exclusion criteria (21 listed)
- Have HRCT and or surgical lung biopsy results inconsistent with the diagnosis of non-CF bronchiectasis. (Exclusion of emphysema and or diffuse parenchymal disease)
- be unable to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform Pulmonary Function Tests (PFT) or HRCT, undergo blood draws, read and respond to questionnaire
- If a female of childbearing potential, have a follicle stimulating hormone (FSH) under 25.8 IU/L
- be actively treated for an acute infectious exacerbation of bronchiectasis
- Have an active infection that is not treated
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 |
|---|---|---|
| hMSCsAlso: allogeneic mesenchymal stem cellintravenous infusion of bone marrow-derived allogeneic stem cells | Biological | Group 1, Group 2 |
Primary outcome
Number of Participant with treatment emergent serious adverse events
Time frame: Week 4 post infusion
incidence of any treatment-emergent serious adverse events defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities
5 secondary outcomes
Difference in Colony Forming Units (CFUs) in semiquantitative culture of sputum
Time frame: Participants will be followed from 1 week to an expected average of 24 weeks following infusion.
rate of decline of lung function
Time frame: Participants will be followed from 12 weeks to an expected average of 24 weeks following infusion.
frequency of acute exacerbations
Time frame: Participants will be followed from 12 weeks to an expected average of 48 weeks following infusion.
reported dyspnea and quality of life assessment
Time frame: Participants will be followed from 4 weeks to an expected average of 48 weeks following infusion.
death from any cause
Time frame: Participants will be followed for the duration of the trial, which is an expected average of 48 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 21458738King P. Pathogenesis of bronchiectasis. Paediatr Respir Rev. 2011 Jun;12(2):104-10. doi: 10.1016/j.prrv.2010.10.011. Epub 2010 Nov 24.
- BackgroundWeycker D, Edelsberg J, Oster G, Tino G. Prevalence and economic burden of bronchiectasis. Clin Pulm Med. 2005;12(4):205-9
- Background: PubMed 22302301Seitz AE, Olivier KN, Adjemian J, Holland SM, Prevots DR. Trends in bronchiectasis among medicare beneficiaries in the United States, 2000 to 2007. Chest. 2012 Aug;142(2):432-439. doi: 10.1378/chest.11-2209.
- Background: PubMed 25246664Bilton D, Tino G, Barker AF, Chambers DC, De Soyza A, Dupont LJ, O'Dochartaigh C, van Haren EH, Vidal LO, Welte T, Fox HG, Wu J, Charlton B; B-305 Study Investigators. Inhaled mannitol for non-cystic fibrosis bronchiectasis: a randomised, controlled trial. Thorax. 2014 Dec;69(12):1073-9. doi: 10.1136/thoraxjnl-2014-205587. Epub 2014 Sep 21.
- Background: PubMed 25323621Quittner AL, O'Donnell AE, Salathe MA, Lewis SA, Li X, Montgomery AB, O'Riordan TG, Barker AF. Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Thorax. 2015 Jan;70(1):12-20. doi: 10.1136/thoraxjnl-2014-205918. Epub 2014 Oct 16.
- Background: PubMed 22901887Wong C, Jayaram L, Karalus N, Eaton T, Tong C, Hockey H, Milne D, Fergusson W, Tuffery C, Sexton P, Storey L, Ashton T. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):660-7. doi: 10.1016/S0140-6736(12)60953-2.
- Background: PubMed 25458200Rogers GB, Bruce KD, Martin ML, Burr LD, Serisier DJ. The effect of long-term macrolide treatment on respiratory microbiota composition in non-cystic fibrosis bronchiectasis: an analysis from the randomised, double-blind, placebo-controlled BLESS trial. Lancet Respir Med. 2014 Dec;2(12):988-96. doi: 10.1016/S2213-2600(14)70213-9. Epub 2014 Oct 14.
- Background: PubMed 23532241Altenburg J, de Graaff CS, Stienstra Y, Sloos JH, van Haren EH, Koppers RJ, van der Werf TS, Boersma WG. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013 Mar 27;309(12):1251-9. doi: 10.1001/jama.2013.1937.
- Background: PubMed 17641052Gupta N, Su X, Popov B, Lee JW, Serikov V, Matthay MA. Intrapulmonary delivery of bone marrow-derived mesenchymal stem cells improves survival and attenuates endotoxin-induced acute lung injury in mice. J Immunol. 2007 Aug 1;179(3):1855-63. doi: 10.4049/jimmunol.179.3.1855.
- Background: PubMed 19721001Lee JW, Fang X, Gupta N, Serikov V, Matthay MA. Allogeneic human mesenchymal stem cells for treatment of E. coli endotoxin-induced acute lung injury in the ex vivo perfused human lung. Proc Natl Acad Sci U S A. 2009 Sep 22;106(38):16357-62. doi: 10.1073/pnas.0907996106. Epub 2009 Aug 31.
- Background: PubMed 20554518Fang X, Neyrinck AP, Matthay MA, Lee JW. Allogeneic human mesenchymal stem cells restore epithelial protein permeability in cultured human alveolar type II cells by secretion of angiopoietin-1. J Biol Chem. 2010 Aug 20;285(34):26211-22. doi: 10.1074/jbc.M110.119917. Epub 2010 Jun 16.
- Background: PubMed 22250097Gupta N, Krasnodembskaya A, Kapetanaki M, Mouded M, Tan X, Serikov V, Matthay MA. Mesenchymal stem cells enhance survival and bacterial clearance in murine Escherichia coli pneumonia. Thorax. 2012 Jun;67(6):533-9. doi: 10.1136/thoraxjnl-2011-201176. Epub 2012 Jan 16.
- Individual participant dataSharing planned: No
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Bronchiectasis
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.
Glassberg K Marilyn, MD principal investigator
University of Miami
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 hMSCs in people with Bronchiectasis, run by Marilyn Glassberg at 1 site in United States.
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 10 inclusion and 21 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: finished, as of the sponsor's last update on 28 Aug 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant with treatment emergent serious adverse events (time frame: Week 4 post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625246, which also lists 63 linked publications.
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 28 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.