Chest
Original ResearchCOPDA Placebo-Controlled, Randomized Trial of Mesenchymal Stem Cells in COPD
Section snippets
Study Design and Oversight
A prospective, randomized, double-blind, placebo (vehicle)-controlled design was used, and participants were recruited from six different institutions in the United States. The study was approved by the institutional review board for each participating center and written informed consent obtained from each participant. An independent data and safety monitoring board approved all amendments and oversaw conduct of the trial. The study (NCT00683722) was conducted in accordance with the amended
Patients
All 62 randomized patients completed all four Prochymal infusions (intent-to-treat population). The baseline characteristics of the intent-to-treat populations are summarized in Table 2, Table 3. The two treatment groups were generally well matched, although the patients receiving MSCs tended to be older than the patients receiving placebo (mean age, 68.1 years vs 64.1 years, respectively) and there were more current smokers in the placebo group (37.5% placebo group vs 16.7% MSC group). The
Discussion
Administration of either autologous or non-HLA-matched allogeneic MSCs is increasingly being investigated as a potential therapeutic intervention for a range of inflammatory and immune diseases. Clinical trials to date have demonstrated safety of systemic MSC infusion and, thus far, there do not appear to be any significant AEs in follow-up periods lasting for several years in a variety of patient populations.9., 10., 11., 12., 35. Concerns of special interest, including ectopic tissue
Acknowledgments
Author contributions: Dr Weiss had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Dr Weiss: contributed to study design, data acquisition and interpretation, drafting and revising the article, and final approval of the article; and served as principle author.
Dr Casaburi: contributed to data acquisition and interpretation, drafting and revising the article, and final approval of the article.
Ms Flannery:
References (43)
Mesenchymal stromal cells: new directions
Cell Stem Cell
(2012)- et al.
Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation
Mol Ther
(2012) - et al.
Autologous transplantation of adipose tissue-derived stromal cells ameliorates pulmonary emphysema
Am J Transplant
(2006) - 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) - et al.
Paracrine factors of multipotent stromal cells ameliorate lung injury in an elastase-induced emphysema model
Mol Ther
(2011) - 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) - 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) - et al.
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) - et al.
The St George's Respiratory Questionnaire
Respir Med
(1991) - et al.
Defining the risks of mesenchymal stromal cell therapy
Cytotherapy
(2010)
All MSCs are pericytes?
Cell Stem Cell
Therapeutic potential of mesenchymal stem cells for severe acute lung injury
Chest
Deaths: preliminary data for 2008
Natl Vital Stat Rep
Chronic obstructive pulmonary disease: current burden and future projections
Eur Respir J
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
Fibroblast precursors in normal and irradiated mouse hematopoietic organs
Exp Hematol
Multilineage potential of adult human mesenchymal stem cells
Science
Immunomodulatory properties and therapeutic application of mesenchymal stem cells
Clin Exp Immunol
From the laboratory bench to the patient's bedside: an update on clinical trials with mesenchymal stem cells
J Cell Physiol
Mesenchymal stem cells in health and disease
Nat Rev Immunol
Clinical trials for stem cell therapies
BMC Med
Cited by (330)
Long-acting inhaled medicines: Present and future
2024, Advanced Drug Delivery ReviewsThe application of MSCs in regenerative medicine
2023, Mesenchymal Stem Cells: Biological Concepts, Current Advances, Opportunities and ChallengesCurrent research status of mesenchymal stem cell therapy for chronic obstructive pulmonary disease
2024, Journal of Chinese PhysicianThe future drug treatment of COPD
2024, ERS MonographApplication of mesenchymal stem cells for anti-senescence and clinical challenges
2023, Stem Cell Research and Therapy
Preliminary results of this study were presented at the Stem Cells and Cell Therapies in Lung Biology and Diseases Conference, July 2011, Burlington, VT.
Funding/Support: Osiris Therapeutics Inc provided funding for the investigation.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.