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Infographic: cell therapy regulation

Take a look out our infographic on the landscape of cell therapy regulation. Do you agree with our poll results? Let us know!

Go to the profile of RegMedNet
Jun 01, 2017

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Go to the profile of Falk Heinrichsohn
Falk Heinrichsohn almost 3 years ago

I believe that "heavily manipulated cell and gene related products", as a disruptive technology also in the new regenerative medicine field, need to be regulated in order to protect patients from side effects of approved drugs like before. What is however not correct is, that we are regulating regenerative medicine in some countries with the same regulations we have established in the 20st century for chemicals and biologicals. Japan has already in 2004 adopted, better changed its regulation by approving a new regenerative medicine regulation and is advancing like many other, non FDA and EMA regulated countries, with its technology and treatment know how with light speed, benefiting patients and payers alike.

What most countries (from Japan, South Korea, Australia, Panama, Mexico to mention a few, including the US) have also accepted, is that autologous cellular treatment in a point of care setting is regulated by the medical board and not by regulatory authorities like the FDA or EMA, and is in the responsibility of a treating physician. The FDA in its regulation (21 CFR 1271.15b) confirms, that autologous cellular treatment as a medical procedure in a point of care center is outside the FDA regulation, but tries to regulate it with new guidelines.

Safety concerns in the form as described for heavily manipulated drugs, do not exist in autologous treatments, as we are taking cells from a body and return them, minimally manipulated back in a medical procedure, to the same body.

Those stakeholders, preferring the industrial related model, are trying to brand those activities as "unproven, unauthorized and dangerous stem cell treatments" performed by unethical clinics and doctors. Fact is, that more than 600 clinics worldwide offering autologous stem cell treatment with outstanding safety
record and astonishing success at patients, and even in the public hearing in September in the US by the FDA, it was revealed that more than 20000 people had been treated in the US already in 2012, and in the last 5 years, only a few patients (4 known registered cases) had faced some registered side effects. In many studies (not trial) with thousands of treated patients it is shown that autologous stem cell treatment is safe.

As mentioned before, there are interests by the various stakeholders involved, and as for autologous stem cell treatment, as a medical procedure only few supportive low priced drugs are needed, and as only equipment used has the possibility to be patented, not much industrial support exists.

Furthermore it appears that EMA, even in their own regulation states, that they are responsible with its "ATMP regulations for products produced industrially and scheduled to be sold in the member countries". Autologous stem cell treatment is a personalized treatment for a singular patient, and rightfully, in countries outside the EMA territory, are outside the existing drug / regenerative medicine regulation. Even in the US, as mentioned above the FDA does not regulate medical procedures, although certain stakeholders are trying to suggest that the FDA should regulate this activity, while most countries have seen the opportunity to help patients with unmet medical need already today with modern science based technologies and autologous stem cell PoC treatments.

In a recent request at EMA representatives, we made in an EMA country, we had been informed that "Point of Care (PoC)" in their regulation does not exists, and that therefore autologous stem cell treatment has to follow the existing drug regulation, which in most global countries had been already adjusted to reflect the new science driven technology. Obviously we are defending at EMA, a safety concern, which other countries for autologous stem cell treatments in a medical procedure do not see anymore, but again we are not talking about how to support patients, but how to defend outdated regulations.

Patient Advocates:
We love our own stem cells, supporting natural regeneration to improve and maintain a health body, and we go to countries with qualified clinics where it is provided, to help patients with unmet medical need.

Globalization for industry means, to find the right place where goods and services can be produced in good quality at prices allowing to sell products with a sustainable and profitable margin globally, and in their home country.

Globalization for patients means, also to evaluate risks and benefits for treatment established in a global environment, and benefit from places where governments already have seen and supported new medicinal treatment methods, still not considered safe in their home-countries. ---- The "Not invented here syndrome" should not exist when it comes to help patients with unmet medical need.

Go to the profile of Freya Leask
Freya Leask almost 3 years ago

Thank you for sharing your thoughts, Falk - "not invented here syndrome" will indeed be an point of contention as the industry continues to develop.

We'll be discussing the infographic in more detail in our panel discussion in a few weeks time - I'd love for you to join us and maybe even submit some questions to our experts: