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Statement on unproven stem cell interventions for lung diseases (Updated statement)

A central component of the mission of medical societies is to translate new scientific information into patient education. The undersigned respiratory and thoracic societies and patient advocacy groups strongly believe that the public and patients should have at their disposal, unbiased and scientifically sound information on therapeutic options including cell-based treatments.

Tremendous advances in stem cell biology have created justified excitement at the prospect of personalized stem cell-based therapies through the use of clinically relevant cell populations. We recognize the enormous potential of stem cells for disease management including acute and chronic ailments of the respiratory system and for critical illnesses. As we learn more about the therapeutic potential of stem cells and other cell therapies in clinical trials of non-lung diseases and in initial trials in lung diseases and critical illnesses, we hope to move towards further consideration of these approaches.

However, as with all medical interventions, patient safety must be the top priority of any prospective stem cell-based therapy or treatment. As yet, there is very little known about the short and long term effects of administering any type of stem cell-based therapy to patients with lung diseases. Until we know more, we must be strongly concerned that the treatment could cause adverse effects and could worsen the patient's condition rather than improve it.

At present, there are only a small number of approved clinical trials in the United States, Canada, the European Union, Brazil, Asia and Australia investigating cell therapy approaches for lung diseases. These can be found on the website of the National Institutes of Health at www.clinicaltrials.gov and of the European Medicines Agency at https://www.clinicaltrialsregister.eu/ctr-search/search.

Thus, we are particularly wary of the ever-increasing examples of direct-to-consumer advertising of untested, unapproved and potentially dangerous “stem-cell” treatments that take place in several countries. One may come across information on the internet or other sources about stem cells being administered to patients with lung diseases, such as emphysema, pulmonary hypertension, cystic fibrosis, or pulmonary fibrosis. These trials may be listed as occurring in several locations worldwide.

We strongly caution all patients that the claims of benefit being made by many of these programs have not been substantiated nor have they been reviewed by experts in the field or any regulatory agency. These programs differ substantially from approved therapies, well-designed and controlled clinical trials, and compassionate use of cell therapies in several aspects such as exorbitant fees, misrepresentation of risks and benefits, poor patient follow-up and absence of regulatory oversight and objective clinical evidence for benefit. Because of the potential for harm and the lack of any proven benefit we strongly caution you not to participate in these or any other comparable unauthorized or unapproved stem cell interventions, unless independent credible, reliable, and objective sources of information are available to substantiate the information and claims being made.

We urge patient advocacy groups and foundations to work together with their national respiratory and thoracic societies, their local chapters, and with regulatory agencies on the issues of stem cell medical tourism and unproven stem cell interventions. Open channels of communication between these organizations and dissemination of reliable, evidence-based information through patient networks, will ensure that lung patients take informed and safe decisions regarding cell-based treatments.

One such reliable source of information is the International Society for Stem Cell Research (ISSCR), which has developed an excellent web-based resource that includes the ISSCR patient handbook (http://www.isscr.org/home/publications/ClinTransGuide). The handbook provides information on mechanisms for monitoring or substantiating the claims being made by various organizations that claim to offer “stem cell therapies”.

Additional resources are provided by the International Society for Cellular Therapy (ISCT website), the California Institute for Regenerative Medicine (CIRM website), the Canadian Stem Cell Network (Stem Cell Network website) and the Canadian Stem Cell Foundation (CSCF website).