A placebo-controlled, randomized trial of mesenchymal stem cells in COPD

Chest

Volumn 143, Issue 6, 2013, Pages 1590-1598

  Weiss, Daniel J ^a   Casaburi, Richard ^b   Flannery, Robin ^c   LeRoux Williams, Michelle ^c   Tashkin, Donald P ^d  

^a UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

^b UCLA MEDICAL CENTER   (United States)

^c OSIRIS THERAPEUTICS INC   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; GAMMA INTERFERON; INTERLEUKIN 10; INTERLEUKIN 2; INTERLEUKIN 4; INTERLEUKIN 5; PLACEBO; REMESTEMCEL L; TRANSFORMING GROWTH FACTOR BETA; TUMOR NECROSIS FACTOR ALPHA;

ADULT; AGED; ARTICLE; BRONCHITIS; CALCIUM BLOOD LEVEL; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EFFECTIVENESS; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; COUGHING; DISEASE ACTIVITY; DISEASE EXACERBATION; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG HYPERSENSITIVITY; DYSPNEA; EMPHYSEMA; FEMALE; FOLLOW UP; FUNCTIONAL ASSESSMENT; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL DISEASE; GLUCOSURIA; HEART DISEASE; HEMATURIA; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPESTHESIA; IMMUNOPATHOLOGY; INFLAMMATION; LETHARGY; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MESENCHYMAL STEM CELL TRANSPLANTATION; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SAFETY; PERIPHERAL EDEMA; PNEUMONIA; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; PROTEIN BLOOD LEVEL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; RHINOPHARYNGITIS; SIDE EFFECT; SINUS CONGESTION; SIX MINUTE WALK TEST; SKIN INFECTION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WALKING;

EID: 84878619923     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.12-2094     Document Type: Article

References (43)

1. Miniño AM, Xu JQ, Kochanek K. Deaths: preliminary data for 2008. Natl Vital Stat Rep. 2010;59(2).
2. Lopez AD, Shibuya K, Rao C, et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006;27(2):397-412.
3. Eisner MD, Anthonisen N, Coultas D, et al Committee on Nonsmoking COPD, Environmental and Occupational Health Assembly. An official American Thoracic Society public policy statement: novel risk factors and the global burden of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010;182(5):693-718.
4. Friedenstein AJ, Gorskaja JF, Kulagina NN. Fibroblast precursors in normal and irradiated mouse hematopoietic organs. Exp Hematol. 1976;4(5):267-274.
5. Pittenger MF, Mackay AM, Beck SC, et al. Multilineage potential of adult human mesenchymal stem cells. Science. 1999;284(5411):143-147.
6. Keating A. Mesenchymal stromal cells: new directions. Cell Stem Cell. 2012;10(6):709-716.
7. Shi M, Liu ZW, Wang FS. Immunomodulatory properties and therapeutic application of mesenchymal stem cells. Clin Exp Immunol. 2011;164(1):1-8.
8. Prockop DJ, Oh JY. Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther. 2012;20(1):14-20.
9. Giordano A, Galderisi U, Marino IR. From the laboratory bench to the patient's bedside: an update on clinical trials with mesenchymal stem cells. J Cell Physiol. 2007;211(1):27-35.
10. Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008;8(9):726-736.
11. Trounson A, Thakar RG, Lomax G, Gibbons D. Clinical trials for stem cell therapies. BMC Med. 2011;9:52-64.
12. Wang J, Liao L, Tan J. Mesenchymal-stem-cell-based experimental and clinical trials: current status and open questions. Expert Opin Biol Ther. 2011;11(7):893-909.
13. Weiss DJ, Bertoncello I, Borok Z, et al. Stem cells and cell therapies in lung biology and lung diseases. Proc Am Thorac Soc. 2011;8(3):223-272.
14. Shigemura N, Okumura M, Mizuno S, Imanishi Y, Nakamura T, Sawa Y. Autologous transplantation of adipose tissuederived stromal cells ameliorates pulmonary emphysema. Am J Transplant. 2006;6(11):2592-2600.
15. Yuhgetsu H, Ohno Y, Funaguchi N, et al. Beneficial effects of autologous bone marrow mononuclear cell transplantation against elastase-induced emphysema in rabbits. Exp Lung Res. 2006;32(9):413-426.
16. Adachi Y, Oyaizu H, Taketani S, et al. Treatment and transfer of emphysema by a new bone marrow transplantation method from normal mice to Tsk mice and vice versa. Stem Cells. 2006;24(9):2071-2077.
17. Zhen G, Liu H, Gu N, Zhang H, Xu Y, Zhang Z. Mesenchymal stem cells transplantation protects against rat pulmonary emphysema. Front Biosci. 2008;1(13):3415-3422.
18. Zhen G, Xue Z, Zhao J, et al. Mesenchymal stem cell transplantation increases expression of vascular endothelial growth factor in papain-induced emphysematous lungs and inhibits apoptosis of lung cells. Cytotherapy. 2010;12(5):605-614.
19. Schweitzer KS, Johnstone BH, Garrison J, et al. Adipose stem cell treatment in mice attenuates lung and systemic injury induced by cigarette smoking. Am J Respir Crit Care Med. 2011;183(2):215-225.
20. Katsha AM, Ohkouchi S, Xin H, et al. Paracrine factors of multipotent stromal cells ameliorate lung injury in an elastaseinduced emphysema model. Mol Ther. 2011;19(1):196-203.
21. Hind M, Maden M. Is a regenerative approach viable for the treatment of COPD? Br J Pharmacol. 2011;163(1):106-115.
22. Kebriaei P, Isola L, Bahceci E, et al. Adult human mesenchymal stem cells added to corticosteroid therapy for the treatment of acute graft-versus-host disease. Biol Blood Marrow Transplant. 2009;15(7):804-811.
23. Prasad VK, Lucas KG, Kleiner GI, et al. Efficacy and safety of ex vivo cultured adult human mesenchymal stem cells (Prochymal™) in pediatric patients with severe refractory acute graft-versus-host disease in a compassionate use study. Biol Blood Marrow Transplant. 2011;17(4):534-541.
24. Hare JM, Traverse JH, Henry TD, et al. A randomized, doubleblind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009;54(24):2277-2286.
25. Patel AN, Genovese J. Potential clinical applications of adult human mesenchymal stem cell (Prochymal R) therapy. Stem Cells and Cloning: Advances and Applications. 2011;4:61-72.
26. National Institutes of Health Clinical Center. PROCHYMAL™ (human adult stem cells) for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD). NCT00683722. ClinicalTrials.gov. Bethesda, MD: National Institutes of Health. http://www.clinicaltrials.gov/ct2/show/ NCT00683722. Updated September 23, 2011.
27. Rabe KF, Hurd S, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007;176(6):532-555.
28. Macintyre N, Crapo RO, Viegi G, et al. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005;26(4):720-735.
29. Wise RA, Brown CD. Minimal clinically important differences in the six-minute walk test and the incremental shuttle walking test. COPD. 2005;2(1):125-129.
30. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166(1):111-117.
31. Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.
32. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A selfcomplete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992;145(6):1321-1327.
33. Celli BR, Locantore N, Yates J, et al; ECLIPSE investigators. Inflammatory biomarkers improve clinical prediction of mortality in chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2012;185(10):1065-1072.
34. Zar JH. Biostatistical Analysis. Upper Saddle River, New Jersey: Prentice-Hall, Inc.;1974.
35. Prockop DJ, Brenner M, Fibbe WE, et al. Defining the risks of mesenchymal stromal cell therapy. Cytotherapy. 2010;12(5):576-578.
36. von Bahr L, Batsis I, Moll G, et al. Analysis of tissues following mesenchymal stromal cell therapy in humans indicates limited long-term engraftment and no ectopic tissue formation . Stem Cells. 2012;30(7):1575-1578.
37. Bai L, Lennon DP, Eaton V, et al. Human bone marrow-derived mesenchymal stem cells induce Th2-polarized immune response and promote endogenous repair in animal models of multiple sclerosis. Glia. 2009;57(11):1192-1203.
38. Goodwin M, Sueblinvong V, Eisenhauer P, et al. Bone marrowderived mesenchymal stromal cells inhibit Th2-mediated allergic airways inflammation in mice. Stem Cells. 2011;29(7):1137-1148.
39. Crisan M, Corselli M, Chen CW, Péault B. Multilineage stem cells in the adult: a perivascular legacy? Organogenesis. 2011;7(2):101-104.
40. Caplan AI. All MSCs are pericytes? Cell Stem Cell. 2008;3(3):229-230.
41. Matthay MA, Thompson BT, Read EJ, et al. Therapeutic potential of mesenchymal stem cells for severe acute lung injury. Chest. 2010;138(4):965-972.
42. 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;106(38):16357-16362.
43. Nemeth K, Keane-Myers A, Brown JM, et al. Bone marrow stromal cells use TGF-beta to suppress allergic responses in a mouse model of ragweed-induced asthma. Proc Natl Acad Sci U S A. 2010;107(12):5652-5657.