Allogeneic Human Cells (hMSC) Via Intravenous Delivery in Patients With Mild Asthma
NCT ID: NCT03137199
Last Updated: 2020-05-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE1
Total Enrollment
3 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-06-22
Study Completion Date
2020-04-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A Phase 1 investigation will be performed to test the safety of two doses of bone marrow-derived MSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma
NCT05035862
Asthma
TERMINATED
PHASE1
Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
NCT02192736
Asthma
UNKNOWN
PHASE1/PHASE2
Soluble CD23 Expression in Asthma Patients Treated With OMA
NCT00226200
Asthma
TERMINATED
NA
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
NCT01370317
Asthma
COMPLETED
PHASE1
Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
NCT00679263
Asthma
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A Phase 1 investigation will be performed to test the safety of two doses of bone marrow-derived MSCs (20,000,000 and 100,000,000) administered via peripheralintravenous infusion.
Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 million cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive a single administration of allogeneic hMSCs: 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, diffusing capacity (DLCO), 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.
Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 million cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive a single administration of allogeneic hMSCs: 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, diffusing capacity (DLCO), 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Asthma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
a first group of 3 patients will receive a lower dose of 20 million hMSCs, followed by a second group of 3 patients to receive a dose of 100 million hMSCs
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group receiving 20 million hMSCs
3 patients will receive a single administration of allogeneic hMSCs: 20 x106 (20 million) cells delivered via peripheral intravenous infusion
Group Type
EXPERIMENTAL
hMSCs
Intervention Type
BIOLOGICAL
intravenous infusion of bone marrow-derived allogeneic stem cells
Group receiving 100 million hMSCs
3 patients will receive a single administration of allogeneic hMSCs: 1 x108 (100 million) cells delivered via peripheral intravenous infusion
Group Type
EXPERIMENTAL
hMSCs
Intervention Type
BIOLOGICAL
intravenous infusion of bone marrow-derived allogeneic stem cells
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
hMSCs
intravenous infusion of bone marrow-derived allogeneic stem cells
Intervention Type
BIOLOGICAL
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
allogeneic mesenchymal stem cell
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Provide written informed consent
* be between 18 and 65 years at the time of signing the Informed Consent
* have a clinical diagnosis of asthma prior to screening in accordance with the guidelines of the American Thoracic Society/European Respiratory Society
* ACQ over 1.25
* have a smoking history of less than 10 pack-years total and have not been smoking for at least the last 12 months
* Perform a positive methacholine challenge at screening and repeat positive methacholine challenge at baseline visit (14 days later)
* Have normal or mild obstructive spirometry
* Have normal right heart function as documented by Doppler echo or right heart catheterization
* If female, be surgically sterile, post-menopausal (more than 1 year), or practice double barrier methods of birth control
* Subjects may receive non-drug therapies including oxygen supplementation no greater than 2L/minute, and pulmonary rehabilitation
* Subjects may be on standard of care asthma medications including inhaled corticosteroids-long acting beta agonist at a dose not greater than 1 mg of a fluticasone equivalent
* be between 18 and 65 years at the time of signing the Informed Consent
* have a clinical diagnosis of asthma prior to screening in accordance with the guidelines of the American Thoracic Society/European Respiratory Society
* ACQ over 1.25
* have a smoking history of less than 10 pack-years total and have not been smoking for at least the last 12 months
* Perform a positive methacholine challenge at screening and repeat positive methacholine challenge at baseline visit (14 days later)
* Have normal or mild obstructive spirometry
* Have normal right heart function as documented by Doppler echo or right heart catheterization
* If female, be surgically sterile, post-menopausal (more than 1 year), or practice double barrier methods of birth control
* Subjects may receive non-drug therapies including oxygen supplementation no greater than 2L/minute, and pulmonary rehabilitation
* Subjects may be on standard of care asthma medications including inhaled corticosteroids-long acting beta agonist at a dose not greater than 1 mg of a fluticasone equivalent
Exclusion Criteria
* Have any active infection that is not treated
* Be unable to perform any of the assessments required for endpoint analysis.
* currently receive (or have received within four weeks of screening) experimental agents for the treatment of asthma
* be actively listed (or expecting to be listed in the near future) for transplant of any organ
* Have clinically important abnormal screening laboratory values : blood screening tests (Hematology, Chemistry, CBC including Eosinophil count) results that are not within normal limits (according to UMHC Laboratory Reference Ranges) 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 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
* Have a non-pulmonary condition that limits lifespan to less than a year.
* Have a history of drug or alcohol abuse within the past 24 months.
* Be serum positive for HIV, hepatitis BsAg or Viremia hepatitis C
* Be currently participating (or have participated within the previous 30 days) in an investigational therapeutic or device trial.
* Have hypersensitivity to dimethyl sulfoxide (DMSO)
* Have a resting oxygen saturation (SpO2) on room air of more than 93% at sea level or more than 88% at an altitude above 5,000 feet above sea level (1524 meters)
* Be unable to perform any of the assessments required for endpoint analysis.
* currently receive (or have received within four weeks of screening) experimental agents for the treatment of asthma
* be actively listed (or expecting to be listed in the near future) for transplant of any organ
* Have clinically important abnormal screening laboratory values : blood screening tests (Hematology, Chemistry, CBC including Eosinophil count) results that are not within normal limits (according to UMHC Laboratory Reference Ranges) 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 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
* Have a non-pulmonary condition that limits lifespan to less than a year.
* Have a history of drug or alcohol abuse within the past 24 months.
* Be serum positive for HIV, hepatitis BsAg or Viremia hepatitis C
* Be currently participating (or have participated within the previous 30 days) in an investigational therapeutic or device trial.
* Have hypersensitivity to dimethyl sulfoxide (DMSO)
* Have a resting oxygen saturation (SpO2) on room air of more than 93% at sea level or more than 88% at an altitude above 5,000 feet above sea level (1524 meters)
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Marcus Foundation
OTHER
Sponsor Role
collaborator
Marilyn Glassberg
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marilyn Glassberg
Professor of Medicine, Surgery, and Pediatrics
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marilyn K Glassberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Miller School of Medicine
Miami, Florida, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Szefler SJ, Wenzel S, Brown R, Erzurum SC, Fahy JV, Hamilton RG, Hunt JF, Kita H, Liu AH, Panettieri RA Jr, Schleimer RP, Minnicozzi M. Asthma outcomes: biomarkers. J Allergy Clin Immunol. 2012 Mar;129(3 Suppl):S9-23. doi: 10.1016/j.jaci.2011.12.979.
Reference Type
BACKGROUND
Malmstrom K, Rodriguez-Gomez G, Guerra J, Villaran C, Pineiro A, Wei LX, Seidenberg BC, Reiss TF. Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma. A randomized, controlled trial. Montelukast/Beclomethasone Study Group. Ann Intern Med. 1999 Mar 16;130(6):487-95. doi: 10.7326/0003-4819-130-6-199903160-00005.
Reference Type
BACKGROUND
Damera G, Panettieri RA. Irreversible airway obstruction in asthma: what we lose, we lose early. Allergy Asthma Proc. 2014 Mar-Apr;35(2):111-8. doi: 10.2500/aap.2013.34.3724.
Reference Type
BACKGROUND
Bousquet J, Mantzouranis E, Cruz AA, Ait-Khaled N, Baena-Cagnani CE, Bleecker ER, Brightling CE, Burney P, Bush A, Busse WW, Casale TB, Chan-Yeung M, Chen R, Chowdhury B, Chung KF, Dahl R, Drazen JM, Fabbri LM, Holgate ST, Kauffmann F, Haahtela T, Khaltaev N, Kiley JP, Masjedi MR, Mohammad Y, O'Byrne P, Partridge MR, Rabe KF, Togias A, van Weel C, Wenzel S, Zhong N, Zuberbier T. Uniform definition of asthma severity, control, and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol. 2010 Nov;126(5):926-38. doi: 10.1016/j.jaci.2010.07.019.
Reference Type
BACKGROUND
Pelaia G, Vatrella A, Maselli R. The potential of biologics for the treatment of asthma. Nat Rev Drug Discov. 2012 Dec;11(12):958-72. doi: 10.1038/nrd3792.
Reference Type
BACKGROUND
Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
Reference Type
BACKGROUND
Jia G, Erickson RW, Choy DF, Mosesova S, Wu LC, Solberg OD, Shikotra A, Carter R, Audusseau S, Hamid Q, Bradding P, Fahy JV, Woodruff PG, Harris JM, Arron JR; Bronchoscopic Exploratory Research Study of Biomarkers in Corticosteroid-refractory Asthma (BOBCAT) Study Group. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients. J Allergy Clin Immunol. 2012 Sep;130(3):647-654.e10. doi: 10.1016/j.jaci.2012.06.025. Epub 2012 Aug 1.
Reference Type
BACKGROUND
Lai T, Wang S, Xu Z, Zhang C, Zhao Y, Hu Y, Cao C, Ying S, Chen Z, Li W, Wu B, Shen H. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015 Feb 3;5:8191. doi: 10.1038/srep08191.
Reference Type
BACKGROUND
Peirsman EJ, Carvelli TJ, Hage PY, Hanssens LS, Pattyn L, Raes MM, Sauer KA, Vermeulen F, Desager KN. Exhaled nitric oxide in childhood allergic asthma management: a randomised controlled trial. Pediatr Pulmonol. 2014 Jul;49(7):624-31. doi: 10.1002/ppul.22873. Epub 2013 Sep 4.
Reference Type
BACKGROUND
Anderson WJ, Short PM, Williamson PA, Lipworth BJ. Inhaled corticosteroid dose response using domiciliary exhaled nitric oxide in persistent asthma: the FENOtype trial. Chest. 2012 Dec;142(6):1553-1561. doi: 10.1378/chest.12-1310.
Reference Type
BACKGROUND
Gupta 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.
Reference Type
BACKGROUND
Lee 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.
Reference Type
BACKGROUND
Fang 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.
Reference Type
BACKGROUND
Gupta 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.
Reference Type
BACKGROUND
Krasnodembskaya 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.
Reference Type
BACKGROUND
Krasnodembskaya 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.
Reference Type
BACKGROUND
Lee 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.
Reference Type
BACKGROUND
Nemeth K, Leelahavanichkul A, Yuen PS, Mayer B, Parmelee A, Doi K, Robey PG, Leelahavanichkul K, Koller BH, Brown JM, Hu X, Jelinek I, Star RA, Mezey E. Bone marrow stromal cells attenuate sepsis via prostaglandin E(2)-dependent reprogramming of host macrophages to increase their interleukin-10 production. Nat Med. 2009 Jan;15(1):42-9. doi: 10.1038/nm.1905. Epub 2008 Nov 21.
Reference Type
BACKGROUND
Ortiz LA, Dutreil M, Fattman C, Pandey AC, Torres G, Go K, Phinney DG. Interleukin 1 receptor antagonist mediates the antiinflammatory and antifibrotic effect of mesenchymal stem cells during lung injury. Proc Natl Acad Sci U S A. 2007 Jun 26;104(26):11002-7. doi: 10.1073/pnas.0704421104. Epub 2007 Jun 14.
Reference Type
BACKGROUND
Mei SH, Haitsma JJ, Dos Santos CC, Deng Y, Lai PF, Slutsky AS, Liles WC, Stewart DJ. Mesenchymal stem cells reduce inflammation while enhancing bacterial clearance and improving survival in sepsis. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1047-57. doi: 10.1164/rccm.201001-0010OC. Epub 2010 Jun 17.
Reference Type
BACKGROUND
Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler RM, Bacigalupo A, Fibbe W, Ringden O; Developmental Committee of the European Group for Blood and Marrow Transplantation. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet. 2008 May 10;371(9624):1579-86. doi: 10.1016/S0140-6736(08)60690-X.
Reference Type
BACKGROUND
Lee RH, Seo MJ, Reger RL, Spees JL, Pulin AA, Olson SD, Prockop DJ. Multipotent stromal cells from human marrow home to and promote repair of pancreatic islets and renal glomeruli in diabetic NOD/scid mice. Proc Natl Acad Sci U S A. 2006 Nov 14;103(46):17438-43. doi: 10.1073/pnas.0608249103. Epub 2006 Nov 6.
Reference Type
BACKGROUND
Parekkadan B, van Poll D, Suganuma K, Carter EA, Berthiaume F, Tilles AW, Yarmush ML. Mesenchymal stem cell-derived molecules reverse fulminant hepatic failure. PLoS One. 2007 Sep 26;2(9):e941. doi: 10.1371/journal.pone.0000941.
Reference Type
BACKGROUND
Togel F, Hu Z, Weiss K, Isaac J, Lange C, Westenfelder C. Administered mesenchymal stem cells protect against ischemic acute renal failure through differentiation-independent mechanisms. Am J Physiol Renal Physiol. 2005 Jul;289(1):F31-42. doi: 10.1152/ajprenal.00007.2005. Epub 2005 Feb 15.
Reference Type
BACKGROUND
Iso Y, Spees JL, Serrano C, Bakondi B, Pochampally R, Song YH, Sobel BE, Delafontaine P, Prockop DJ. Multipotent human stromal cells improve cardiac function after myocardial infarction in mice without long-term engraftment. Biochem Biophys Res Commun. 2007 Mar 16;354(3):700-6. doi: 10.1016/j.bbrc.2007.01.045. Epub 2007 Jan 17.
Reference Type
BACKGROUND
Schuleri KH, Feigenbaum GS, Centola M, Weiss ES, Zimmet JM, Turney J, Kellner J, Zviman MM, Hatzistergos KE, Detrick B, Conte JV, McNiece I, Steenbergen C, Lardo AC, Hare JM. Autologous mesenchymal stem cells produce reverse remodelling in chronic ischaemic cardiomyopathy. Eur Heart J. 2009 Nov;30(22):2722-32. doi: 10.1093/eurheartj/ehp265. Epub 2009 Jul 8.
Reference Type
BACKGROUND
Miyahara Y, Nagaya N, Kataoka M, Yanagawa B, Tanaka K, Hao H, Ishino K, Ishida H, Shimizu T, Kangawa K, Sano S, Okano T, Kitamura S, Mori H. Monolayered mesenchymal stem cells repair scarred myocardium after myocardial infarction. Nat Med. 2006 Apr;12(4):459-65. doi: 10.1038/nm1391. Epub 2006 Apr 2.
Reference Type
BACKGROUND
Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055.
Reference Type
BACKGROUND
Gong Z, Niklason LE. Use of human mesenchymal stem cells as alternative source of smooth muscle cells in vessel engineering. Methods Mol Biol. 2011;698:279-94. doi: 10.1007/978-1-60761-999-4_21.
Reference Type
BACKGROUND
Price AP, England KA, Matson AM, Blazar BR, Panoskaltsis-Mortari A. Development of a decellularized lung bioreactor system for bioengineering the lung: the matrix reloaded. Tissue Eng Part A. 2010 Aug;16(8):2581-91. doi: 10.1089/ten.TEA.2009.0659.
Reference Type
BACKGROUND
Deans RJ, Moseley AB. Mesenchymal stem cells: biology and potential clinical uses. Exp Hematol. 2000 Aug;28(8):875-84. doi: 10.1016/s0301-472x(00)00482-3.
Reference Type
BACKGROUND
Ishizawa K, Kubo H, Yamada M, Kobayashi S, Numasaki M, Ueda S, Suzuki T, Sasaki H. Bone marrow-derived cells contribute to lung regeneration after elastase-induced pulmonary emphysema. FEBS Lett. 2004 Jan 2;556(1-3):249-52. doi: 10.1016/s0014-5793(03)01399-1.
Reference Type
BACKGROUND
Spees JL, Pociask DA, Sullivan DE, Whitney MJ, Lasky JA, Prockop DJ, Brody AR. Engraftment of bone marrow progenitor cells in a rat model of asbestos-induced pulmonary fibrosis. Am J Respir Crit Care Med. 2007 Aug 15;176(4):385-94. doi: 10.1164/rccm.200607-1004OC. Epub 2007 May 11.
Reference Type
BACKGROUND
Spees JL, Whitney MJ, Sullivan DE, Lasky JA, Laboy M, Ylostalo J, Prockop DJ. Bone marrow progenitor cells contribute to repair and remodeling of the lung and heart in a rat model of progressive pulmonary hypertension. FASEB J. 2008 Apr;22(4):1226-36. doi: 10.1096/fj.07-8076com. Epub 2007 Nov 21.
Reference Type
BACKGROUND
Bonfield TL, Koloze M, Lennon DP, Zuchowski B, Yang SE, Caplan AI. Human mesenchymal stem cells suppress chronic airway inflammation in the murine ovalbumin asthma model. Am J Physiol Lung Cell Mol Physiol. 2010 Dec;299(6):L760-70. doi: 10.1152/ajplung.00182.2009. Epub 2010 Sep 3.
Reference Type
BACKGROUND
Lin HY, Xu L, Xie SS, Yu F, Hu HY, Song XL, Wang CH. Mesenchymal stem cells suppress lung inflammation and airway remodeling in chronic asthma rat model via PI3K/Akt signaling pathway. Int J Clin Exp Pathol. 2015 Aug 1;8(8):8958-67. eCollection 2015.
Reference Type
BACKGROUND
Trzil JE, Masseau I, Webb TL, Chang CH, Dodam JR, Liu H, Quimby JM, Dow SW, Reinero CR. Intravenous adipose-derived mesenchymal stem cell therapy for the treatment of feline asthma: a pilot study. J Feline Med Surg. 2016 Dec;18(12):981-990. doi: 10.1177/1098612X15604351. Epub 2015 Sep 17.
Reference Type
BACKGROUND
Gao J, Dennis JE, Muzic RF, Lundberg M, Caplan AI. The dynamic in vivo distribution of bone marrow-derived mesenchymal stem cells after infusion. Cells Tissues Organs. 2001;169(1):12-20. doi: 10.1159/000047856.
Reference Type
BACKGROUND
Cargnoni A, Gibelli L, Tosini A, Signoroni PB, Nassuato C, Arienti D, Lombardi G, Albertini A, Wengler GS, Parolini O. Transplantation of allogeneic and xenogeneic placenta-derived cells reduces bleomycin-induced lung fibrosis. Cell Transplant. 2009;18(4):405-22. doi: 10.3727/096368909788809857.
Reference Type
BACKGROUND
Moodley Y, Atienza D, Manuelpillai U, Samuel CS, Tchongue J, Ilancheran S, Boyd R, Trounson A. Human umbilical cord mesenchymal stem cells reduce fibrosis of bleomycin-induced lung injury. Am J Pathol. 2009 Jul;175(1):303-13. doi: 10.2353/ajpath.2009.080629. Epub 2009 Jun 4.
Reference Type
BACKGROUND
Lee SH, Jang AS, Kim YE, Cha JY, Kim TH, Jung S, Park SK, Lee YK, Won JH, Kim YH, Park CS. Modulation of cytokine and nitric oxide by mesenchymal stem cell transfer in lung injury/fibrosis. Respir Res. 2010 Feb 8;11(1):16. doi: 10.1186/1465-9921-11-16.
Reference Type
BACKGROUND
Rojas M, Xu J, Woods CR, Mora AL, Spears W, Roman J, Brigham KL. Bone marrow-derived mesenchymal stem cells in repair of the injured lung. Am J Respir Cell Mol Biol. 2005 Aug;33(2):145-52. doi: 10.1165/rcmb.2004-0330OC. Epub 2005 May 12.
Reference Type
BACKGROUND
Ortiz LA, Gambelli F, McBride C, Gaupp D, Baddoo M, Kaminski N, Phinney DG. Mesenchymal stem cell engraftment in lung is enhanced in response to bleomycin exposure and ameliorates its fibrotic effects. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8407-11. doi: 10.1073/pnas.1432929100. Epub 2003 Jun 18.
Reference Type
BACKGROUND
Jiang Y, Jahagirdar BN, Reinhardt RL, Schwartz RE, Keene CD, Ortiz-Gonzalez XR, Reyes M, Lenvik T, Lund T, Blackstad M, Du J, Aldrich S, Lisberg A, Low WC, Largaespada DA, Verfaillie CM. Pluripotency of mesenchymal stem cells derived from adult marrow. Nature. 2002 Jul 4;418(6893):41-9. doi: 10.1038/nature00870. Epub 2002 Jun 20.
Reference Type
BACKGROUND
Kotton DN, Ma BY, Cardoso WV, Sanderson EA, Summer RS, Williams MC, Fine A. Bone marrow-derived cells as progenitors of lung alveolar epithelium. Development. 2001 Dec;128(24):5181-8. doi: 10.1242/dev.128.24.5181.
Reference Type
BACKGROUND
Sueblinvong V, Loi R, Eisenhauer PL, Bernstein IM, Suratt BT, Spees JL, Weiss DJ. Derivation of lung epithelium from human cord blood-derived mesenchymal stem cells. Am J Respir Crit Care Med. 2008 Apr 1;177(7):701-11. doi: 10.1164/rccm.200706-859OC. Epub 2007 Dec 6.
Reference Type
BACKGROUND
Ma N, Gai H, Mei J, Ding FB, Bao CR, Nguyen DM, Zhong H. Bone marrow mesenchymal stem cells can differentiate into type II alveolar epithelial cells in vitro. Cell Biol Int. 2011 Dec;35(12):1261-6. doi: 10.1042/CBI20110026.
Reference Type
BACKGROUND
Yamada M, Kubo H, Kobayashi S, Ishizawa K, Numasaki M, Ueda S, Suzuki T, Sasaki H. Bone marrow-derived progenitor cells are important for lung repair after lipopolysaccharide-induced lung injury. J Immunol. 2004 Jan 15;172(2):1266-72. doi: 10.4049/jimmunol.172.2.1266.
Reference Type
BACKGROUND
Chang JC, Summer R, Sun X, Fitzsimmons K, Fine A. Evidence that bone marrow cells do not contribute to the alveolar epithelium. Am J Respir Cell Mol Biol. 2005 Oct;33(4):335-42. doi: 10.1165/rcmb.2005-0129OC. Epub 2005 Jun 16.
Reference Type
BACKGROUND
Kotton DN, Fabian AJ, Mulligan RC. Failure of bone marrow to reconstitute lung epithelium. Am J Respir Cell Mol Biol. 2005 Oct;33(4):328-34. doi: 10.1165/rcmb.2005-0175RC. Epub 2005 Jun 16.
Reference Type
BACKGROUND
Kumamoto M, Nishiwaki T, Matsuo N, Kimura H, Matsushima K. Minimally cultured bone marrow mesenchymal stem cells ameliorate fibrotic lung injury. Eur Respir J. 2009 Sep;34(3):740-8. doi: 10.1183/09031936.00128508. Epub 2009 Mar 26.
Reference Type
BACKGROUND
Bitencourt CS, Pereira PA, Ramos SG, Sampaio SV, Arantes EC, Aronoff DM, Faccioli LH. Hyaluronidase recruits mesenchymal-like cells to the lung and ameliorates fibrosis. Fibrogenesis Tissue Repair. 2011 Jan 13;4(1):3. doi: 10.1186/1755-1536-4-3.
Reference Type
BACKGROUND
Tashiro J, Elliot SJ, Gerth DJ, Xia X, Pereira-Simon S, Choi R, Catanuto P, Shahzeidi S, Toonkel RL, Shah RH, El Salem F, Glassberg MK. Therapeutic benefits of young, but not old, adipose-derived mesenchymal stem cells in a chronic mouse model of bleomycin-induced pulmonary fibrosis. Transl Res. 2015 Dec;166(6):554-67. doi: 10.1016/j.trsl.2015.09.004. Epub 2015 Sep 18.
Reference Type
BACKGROUND
Lee SH, Lee EJ, Lee SY, Kim JH, Shim JJ, Shin C, In KH, Kang KH, Uhm CS, Kim HK, Yang KS, Park S, Kim HS, Kim YM, Yoo TJ. The effect of adipose stem cell therapy on pulmonary fibrosis induced by repetitive intratracheal bleomycin in mice. Exp Lung Res. 2014 Apr;40(3):117-25. doi: 10.3109/01902148.2014.881930.
Reference Type
BACKGROUND
Royce SG, Shen M, Patel KP, Huuskes BM, Ricardo SD, Samuel CS. Mesenchymal stem cells and serelaxin synergistically abrogate established airway fibrosis in an experimental model of chronic allergic airways disease. Stem Cell Res. 2015 Nov;15(3):495-505. doi: 10.1016/j.scr.2015.09.007. Epub 2015 Sep 25.
Reference Type
BACKGROUND
Xu J, Mora A, Shim H, Stecenko A, Brigham KL, Rojas M. Role of the SDF-1/CXCR4 axis in the pathogenesis of lung injury and fibrosis. Am J Respir Cell Mol Biol. 2007 Sep;37(3):291-9. doi: 10.1165/rcmb.2006-0187OC. Epub 2007 Apr 26.
Reference Type
BACKGROUND
Antoniou KM, Papadaki HA, Soufla G, Kastrinaki MC, Damianaki A, Koutala H, Spandidos DA, Siafakas NM. Investigation of bone marrow mesenchymal stem cells (BM MSCs) involvement in Idiopathic Pulmonary Fibrosis (IPF). Respir Med. 2010 Oct;104(10):1535-42. doi: 10.1016/j.rmed.2010.04.015. Epub 2010 May 18.
Reference Type
BACKGROUND
Wilson JG, Liu KD, Zhuo H, Caballero L, McMillan M, Fang X, Cosgrove K, Vojnik R, Calfee CS, Lee JW, Rogers AJ, Levitt J, Wiener-Kronish J, Bajwa EK, Leavitt A, McKenna D, Thompson BT, Matthay MA. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial. Lancet Respir Med. 2015 Jan;3(1):24-32. doi: 10.1016/S2213-2600(14)70291-7. Epub 2014 Dec 17.
Reference Type
BACKGROUND
Liang J, Zhang H, Hua B, Wang H, Lu L, Shi S, Hou Y, Zeng X, Gilkeson GS, Sun L. Allogenic mesenchymal stem cells transplantation in refractory systemic lupus erythematosus: a pilot clinical study. Ann Rheum Dis. 2010 Aug;69(8):1423-9. doi: 10.1136/ard.2009.123463.
Reference Type
BACKGROUND
Weiss DJ, Casaburi R, Flannery R, LeRoux-Williams M, Tashkin DP. A placebo-controlled, randomized trial of mesenchymal stem cells in COPD. Chest. 2013 Jun;143(6):1590-1598. doi: 10.1378/chest.12-2094.
Reference Type
BACKGROUND
Chambers DC, Enever D, Ilic N, Sparks L, Whitelaw K, Ayres J, Yerkovich ST, Khalil D, Atkinson KM, Hopkins PM. A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology. 2014 Oct;19(7):1013-8. doi: 10.1111/resp.12343. Epub 2014 Jul 9.
Reference Type
BACKGROUND
Tzouvelekis A, Paspaliaris V, Koliakos G, Ntolios P, Bouros E, Oikonomou A, Zissimopoulos A, Boussios N, Dardzinski B, Gritzalis D, Antoniadis A, Froudarakis M, Kolios G, Bouros D. A prospective, non-randomized, no placebo-controlled, phase Ib clinical trial to study the safety of the adipose derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis. J Transl Med. 2013 Jul 15;11:171. doi: 10.1186/1479-5876-11-171.
Reference Type
BACKGROUND
Weiss DJ, Chambers D, Giangreco A, Keating A, Kotton D, Lelkes PI, Wagner DE, Prockop DJ; ATS Subcommittee on Stem Cells and Cell Therapies. An official American Thoracic Society workshop report: stem cells and cell therapies in lung biology and diseases. Ann Am Thorac Soc. 2015 Apr;12(4):S79-97. doi: 10.1513/AnnalsATS.201502-086ST.
Reference Type
BACKGROUND
Glassberg MK, Toonkel RL. Moving stem cell therapy to patients with idiopathic pulmonary fibrosis. Respirology. 2014 Oct;19(7):950-1. doi: 10.1111/resp.12364. Epub 2014 Aug 14. No abstract available.
Reference Type
BACKGROUND
Toonkel RL, Hare JM, Matthay MA, Glassberg MK. Mesenchymal stem cells and idiopathic pulmonary fibrosis. Potential for clinical testing. Am J Respir Crit Care Med. 2013 Jul 15;188(2):133-40. doi: 10.1164/rccm.201207-1204PP.
Reference Type
BACKGROUND
Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. doi: 10.1001/jama.2012.25321.
Reference Type
BACKGROUND
Sundin M, Orvell C, Rasmusson I, Sundberg B, Ringden O, Le Blanc K. Mesenchymal stem cells are susceptible to human herpesviruses, but viral DNA cannot be detected in the healthy seropositive individual. Bone Marrow Transplant. 2006 Jun;37(11):1051-9. doi: 10.1038/sj.bmt.1705368.
Reference Type
BACKGROUND
Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
Reference Type
BACKGROUND
Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
Reference Type
BACKGROUND
Jia CE, Zhang HP, Lv Y, Liang R, Jiang YQ, Powell H, Fu JJ, Wang L, Gibson PG, Wang G. The Asthma Control Test and Asthma Control Questionnaire for assessing asthma control: Systematic review and meta-analysis. J Allergy Clin Immunol. 2013 Mar;131(3):695-703. doi: 10.1016/j.jaci.2012.08.023. Epub 2012 Oct 8.
Reference Type
BACKGROUND
Klyushnenkova E, Mosca JD, Zernetkina V, Majumdar MK, Beggs KJ, Simonetti DW, Deans RJ, McIntosh KR. T cell responses to allogeneic human mesenchymal stem cells: immunogenicity, tolerance, and suppression. J Biomed Sci. 2005;12(1):47-57. doi: 10.1007/s11373-004-8183-7.
Reference Type
BACKGROUND
Le Blanc K, Tammik C, Rosendahl K, Zetterberg E, Ringden O. HLA expression and immunologic properties of differentiated and undifferentiated mesenchymal stem cells. Exp Hematol. 2003 Oct;31(10):890-6. doi: 10.1016/s0301-472x(03)00110-3.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.ginasthma.org
Global Initiative for Asthma 2015 from the Global Strategy for Asthma Management and Prevention
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20160350
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Kinetics of IgE Memory B Cells, Plasmablasts and Plasma Cells After Whole Lung Allergen Challenge in Mild Asthmatics
NCT01420003
COMPLETED
NA
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
NCT00127166
COMPLETED
PHASE3
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
NCT00576069
RECRUITING
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
NCT00670930
COMPLETED
PHASE4
Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)
NCT01624974
COMPLETED
PHASE2
Effect of in Vitro Blocking the Common Beta Chain on Cell Viability in Asthma
NCT01759849
COMPLETED
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
NCT01225913
RECRUITING
PHASE4
MK0524 Asthma POC Study (0524-008)(COMPLETED)
NCT00783601
COMPLETED
PHASE2
A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma
NCT00507130
COMPLETED
PHASE2
12-Week Study in Adult Subjects With Asthma
NCT01516073
COMPLETED
PHASE2
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
NCT00046748
COMPLETED
PHASE3
Individualizing Treatment for Asthma in Primary Care
NCT06272370
COMPLETED
PHASE4
A Study of 2 Doses of MAP0010 in Adult Asthmatics
NCT00554970
COMPLETED
PHASE2
A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma
NCT00590720
TERMINATED
PHASE2
Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma
NCT02243189
TERMINATED
PHASE1
A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
NCT01339897
COMPLETED
PHASE1
Asthma Symptom Management Through Mindfulness Training
NCT02275559
COMPLETED
NA
Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594
NCT04002427
COMPLETED
PHASE1
Stem Cell Strategies for the Treatment of Chronic Asthma
NCT04883320
ACTIVE_NOT_RECRUITING
Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)
NCT00092144
COMPLETED
PHASE3
A Study of 2 Doses of MAP0010 in Asthmatic Children
NCT00697697
TERMINATED
PHASE3
A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
NCT01502371
COMPLETED
PHASE2
Comparison Of Molecular Targets In Mild To Severe Asthmatics And Healthy Subjects
NCT00331058
TERMINATED
PHASE1
A Study of MK0359 in Patients With Chronic Asthma (0359-013)
NCT00482898
COMPLETED
PHASE2
MK0476 Study in Adult Patients With Acute Asthma (0476-322)
NCT00229970
COMPLETED
PHASE3