Stem Cell/Cell-Based Therapy for Pulmonary Fibrosis

An Update on Stem Cell/Cell-Based Therapies for Pulmonary Fibrosis Beyond the Context of Clinical Trials

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A word of caution by the Medical Advisory Board of the Pulmonary Fibrosis Foundation (PFF)

This statement has been re-reviewed in January 2022 and is still current.

To members of the Pulmonary Fibrosis Community,

We want to update you on the status of stem cell therapies for the treatment of pulmonary fibrosis. While studies continue to evaluate the potential use of these treatments, there are currently no studies proving that they are helpful. Considering the information available, we strongly recommend that patients not engage in such treatments outside of an approved clinical trial.

As part of a clinical trial:

  • There are no costs or fees associated with participation
  • The cost of the clinical trial is paid for by drug developers or governmental agencies
  • Written informed consent is required
  • Decisions are based on a research protocol
  • It is designed and intended to benefit future patients
  • There are periodic and systematic assessment of patient data
  • The study is protected by government agencies, institutional review adherence to professional and legal standards

More detailed information about clinical trials can be obtained from the PFF website and specific clinical trials evaluating innovative therapies can  be identified using the PFF Clinical Trial Finder. Patients, relatives, advocacy experts, industry, physicians, researchers, and federal agencies  contributed to the prior successes and are essential for further advances. The entire PF community is responsible for this continued progress and our work will continue as we  imagine a world without PF.

On behalf of the Pulmonary Fibrosis Foundation Medical Advisory Board,

william-t-scmidt

William T. Schmidt

PFF President and CEO

joseph-s-lasky

Joseph Lasky, MD

PFF Chief Medical Officer

andrew-limper

Andrew Limper, MD

Chair, Medical Advisory Board

eric-s-white

Eric S. White

Medical Advisory Board

marilyn-s-glassberg

Marilyn K. Glassberg

Medical Advisory Board

doctor-luis-ortiz

Luis Ortiz, MD

Research Review Committee

References

  1. Daley, G. Q. et al. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines. Stem cell reports 6, 787- 797, doi:10.1016/j.stemcr.2016.05.001 (2016).
  2. Daley, G. Q. Polar Extremes in the Clinical Use of Stem Cells. The New England journal of medicine 376, 1075-1077, doi:10.1056/ NEJMe1701379 (2017).
  3. Knoepfler, P. S. & Turner, L. G. The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis. Regen Med 13, 19-27, doi:10.2217/rme-2017-0115 (2018).
  4. Sipp, D., Robey, P. G. & Turner, L. Clear up this stem-cell mess. Nature 561, 455-457, doi:10.1038/d41586-018-06756-9 (2018).
  5. Chambers, D. C. et al. A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology 19, 1013-1018, doi:10.1111/resp.12343 (2014).
  6. Glassberg, M. K. et al. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest 151, 971-981, doi:10.1016/j.chest.2016.10.061 (2017).
  7. Ntolios, P. et al. Longitudinal outcomes of patients enrolled in a phase Ib clinical trial of the adipose-derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis. Clin Respir J 12, 2084-2089, doi:10.1111/crj.12777 (2018).
  8. Serrano-Mollar, A. Cell Therapy in Idiopathic Pulmonary Fibrosis(dagger). Med Sci (Basel) 6, doi:10.3390/medsci6030064 (2018).
  9. Tzouvelekis, A. et al. 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 11, 171, doi:1479-5876-11-171 [pii] 10.1186/1479-5876-11- 171 (2013).
  10. Weiss, D. J., Casaburi, R., Flannery, R., LeRoux-Williams, M. & Tashkin, D. P. A placebo-controlled, randomized trial of mesenchymal stem cells in COPD. Chest 143, 1590-1598, doi:10.1378/chest.12-2094 (2013).
  11. Wilson, J. G. et al. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial. The Lancet. Respiratory medicine 3, 24-32, doi:10.1016/S2213-2600(14)70291-7 (2015).
  12. Keller, C. A. et al. Feasibility, Safety, and Tolerance of Mesenchymal Stem Cell Therapy for Obstructive Chronic Lung Allograft Dysfunction. Stem cells translational medicine 7, 161-167, doi:10.1002/sctm.17-0198 (2018).

Faculty

William T. Schmidt
President and CEO

Joseph Lasky, MD
Chief Medical Officer

Senior Medical Staff

Amy Hajari Case, MD, FCCP
Sonye Danoff, MD, PhD
Kevin Flaherty, MD, MS
Joyce Lee, MD, MS


Medical Advisory Board

Andrew H. Limper, MD*  
CHAIR

Joseph Lasky, MD*  
VICE CHAIR

Jesse Roman, MD  
PAST CHAIR

Michael F. Beers, MD*
Timothy S Blackwell, MD
Amy Hajari Case, MD*
Sonye Danoff, MD, PhD*
Kevin R. Flaherty, MD, MS*
Christine Kim Garcia, MD, PhD
Marilyn Glassberg, MD
Susan S. Jacobs, RN, MS
Naftali Kaminski, MD
David W. Kamp, MD
Melanie Koenigshoff, MD
Martin Kolb, MD
Joyce Lee, MD*
Kathleen O. Lindell, PhD, RN*
James E. Loyd, MD
David A. Lynch, MB, BCh
Fernando J. Martinez, MD, MS
Imre Noth, MD
Pillappa Raghavendra, MD
Ganesh Raghu, MD
Patricia J. Sime, MD*
Charlie Strange III, MD
Jeffrey James Swigris, DO, MS
Janet Talbert, MS, CGC

Please note that titles and affiliations may have changed and appear as they were at the time of the statement's release.