TSANZ adds voice to stem cell concerns

Public health

19 Aug 2016

Australian thoracic specialists have added their collective voice to an international position statement condemning the use of “unproven stem cell interventions for lung diseases” – as the groundswell of multi-disciplinary opposition to the practice grows.

And one leading Australian respiratory physicians and stem cell researcher says specialists should start actively educating their patients about stem cell interventions and the importance of waiting until there is reliable evidence to substantiate both safety and efficacy.

Associate Professor Yuben Moodley, Head of the Stem Cell Unit at the Institute for Respiratory Health in WA, told the limbic physicians needed to understand the pressure patients were under to try anything to improve their chronic condition.

“We need to talk to them and encourage them to follow doctors’ instructions and not partake in this type of treatment unless it is through clinical trials that have the correct ethics and governance,” he said.

“There is a desperation there for some patients, for something new that might turn things around. And coupled with that are these clinics promising a cure or improvement in condition in unchecked, ungoverned clinics.”

The Thoracic Society of Australia and New Zealand and the Transplantation Society of Australia and New Zealand are among 19 international lung, respiratory, and thoracic societies and patient advocacy groups to publicly declare their support for the Assembly on Respiratory Cell & Molecular Biology Stem Cell Working Group statement.

“As yet, there is very little known about the short- and long-term effects in terms of safety and efficacy of administering any type of stem cell-based therapy to patients with lung diseases,” the statement says.

“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 peer reviewed and appropriately regulated approved clinical trials in the United States, Canada, the European Union, Brazil, Asia and Australia investigating cell therapy approaches for lung diseases.”

According to the assembly, information about these can be found here, here and here. The need for action was also covered in an editorial published in the Annals of the American Thoracic Society.

“We are watching these carefully to determine whether they will demonstrate that stem cell-based treatments could be effective and safe for treating lung diseases,” the statement says. “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.”

These so-called treatment clinics are administering unregulated stem cell therapy patients with lung diseases such as emphysema, pulmonary hypertension, cystic fibrosis, or pulmonary fibrosis.

The assembly claims these programs are usually characterised by exorbitant fees, misrepresentation of risks and benefits, overreliance on, and advertisement of patient testimony, poor patient follow-up, and absence of regulatory oversight and objective clinical evidence for claimed benefits.

Professor Moodley said one of the most ‘popular’ stem cell treatments involved the use of mesenchymal stromal cells, and he shared concerns about the efficacy and long-term safety of their use. Acknowledging that many patients went against medical advice to try the therapy, he still said it was important for doctors to approach the issue honestly and without judgement.

“We are not sure if it is effective or in lung diseases it is safe,” he said. “We just don’t know. There is research underway, and there may come a time when stem cell therapy might become part of conventional treatment, but we are not there yet.”

He said he had seen firsthand the desperation that drives patients to want to try stem cell therapies. One of his well-resourced patients recently announced her desire to go to the US for lung disease stem cell therapy. The clinic was up front about the therapy and the fact that it “may or may not work”.

“One can understand why people get desperate,” he said. “She was desperate – but wanted to try something, so we talked to her, and we’ve found better treatments for her to try and she is happy with that.”

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