A new update statement from the Pulmonary Fibrosis Foundation cautions pulmonary fibrosis patients on current stem cell therapy treatments.
It is widely recognized that the field of regenerative medicine, which includes cell-based therapies such as stem cell treatments, holds a lot of potential for the treatment of pulmonary fibrosis. There continues to be extensive research into stem cell therapies to treat this patient population.
Some for-profit stem cell centers offer unapproved therapies
However, these new treatments require evaluation and approval of efficacy and safety through rigorous clinical trials and regulatory review. Unfortunately, there are for-profit stem cell centres where practitioners offer unapproved stem cell therapies. These unproven treatments are being given at unregulated centres and may be putting pulmonary fibrosis patients at risk.
Regulatory agencies have received several reports of severe respiratory illness associated with the administration of unproven stem cell treatments in pulmonary fibrosis patients at for-profit centres. These stem cell therapies do not have approval from regulatory bodies and therefore are missing proper standards for cell preparation, storage and treatment regimen. Their claims of efficacy and safety to consumers are overexaggerated without appropriate scientific evidence to support them.
The Pulmonary Fibrosis Foundation recognizes that patients are often eager to receive therapies that may potentially treat their disease. Current research to date has shown acceptable safety of a type of adult stem cell called termed mesenchymal stem cells (also known as multipotent mesenchymal stromal cells) in the initial phase of clinical trials in pulmonary fibrosis patients. The next steps involve carefully conducted clinical trials to further investigate, assess and determine its efficacy and safety in patients. These trials are currently being planned and organized.
The Pulmonary Fibrosis Foundation urges patients to use caution
The Medical Advisory Board of the Pulmonary Fibrosis Foundation does not endorse the use of unapproved stem cell therapies to treat pulmonary fibrosis and recommend that patients should only receive stem cell therapy as part of an approved clinical trial where they can be closely monitored. Nonetheless, they are hopeful for the future of pulmonary fibrosis treatment as research continues and new clinical trials get underway.
Written by Maggie Leung, PharmD
Reference: Pulmonary Fibrosis Foundation. (2019, March 05). An update of stem cell/cell-based therapies for pulmonary fibrosis beyond the context of clinical trials: A word of caution by the Medical Advisory Board of the Pulmonary Fibrosis Foundation (PFF)[Press release]. Retrieved from https://www.pulmonaryfibrosis.org/docs/default-source/medical-community-documents/stem-cell-statement_march2019ee6af5d09b5d6477b7e4ff000016512a.pdf?sfvrsn=8c37918d_2