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Printable Handouts
Navigable Slide Index
- Introduction
- Cell therapists
- What an ATMP is
- Specific regulations covering cell therapies
- Where to start the academic development process
- ATMP cell therapy trials at RFH & UCL
- Can ATMPs be delivered to GMP in academia
- Should ATMPs be developed in academia
- The ATMP stakeholders
- Why this is a question of ethics (1)
- Why this is a question of ethics (2)
- Phase I/II example - gene transduced MSC bank
- The wider ethical issues
- Transplant organ vs. a recellularized scaffold
- Principles of cell, tissue & organ transplantation
- Do we need human scaffolds
- Xenogeneic integration
- Human tissue integrated into a pig trachea
- Do TEP work (pig vocalization example)
- Current legislation on ATMP specific ethical issues
- Current clinical trials legislation on ATMPs
- Improving ATMPs pipeline
- F-I-M ethical issues
- Making ATMPs widely available
- Consequences of not regulating ATMPs (1)
- Consequences of not regulating ATMPs (2)
- Consequences of not regulating ATMPs (3)
- Should cell & tissue medicines be used yet
- Conclusions
Topics Covered
- What is an ATMP
- Specific regulations covering cell therapies
- Academic development process
- ATMP stakeholders
- Ethical issues, legislation and regulation
- ATMP development
Talk Citation
Lowdell, M. (2015, August 31). The ethics and regulation of cell and tissue therapies in the UK [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 14, 2024, from https://doi.org/10.69645/HGLA8955.Export Citation (RIS)
Publication History
Financial Disclosures
- Professor Lowdell is a founder and shareholder of Achilles Therapeutics Ltd., Autolomous Ltd. (Director), INmuneBio Inc. (Chief Scientific Officer and Director), INmune Ventures Inc. (Director), and Novamune Ltd. (Director). Professor Lowdell is also a consultant to Advent Bio Services Ltd., Autolus Ltd., Avectas Ltd., NWBio Therapeutics Inc., Quell Therapeutics Ltd., and ViroCell Biologics Ltd..
Other Talks in the Series: Tissue in Research
Transcript
Please wait while the transcript is being prepared...
0:00
MARK LOWDELL: Hello,
I'm Mark Lowdell.
I'm the Director of Cell
Therapy here at the Royal Free
Hospital & UCL Medical School.
And today I'm going to talk to you
about the field of cell and tissue
therapies, how they're
regulated, and the impact
that regulation has on the ethics.
0:15
So I'm a Cell Therapist.
I'm not a doctor here
that treats cells.
I'm a scientist that uses human
cells and tissues to make medicines
for tissue engineering,
regenerative medicine, and treating
cancer and immune deficiencies.
0:30
Now these types of
medicines are called
Advance Therapy Medicinal Products.
It's a clumsy term,
and it was defined
really in the first directive of
2001, 83, the Medicines Directive.
And they consist of gene
therapies, somatic cell therapies,
and tissue engineered
products for the purposes
of regenerative medicine.
Here are some examples:
In the lower screen
there you can see
a decellularized human
trachea that we were using
to rebuild a trachea in a child.
On the right of that there
is a bioengineered nose made
out of a biocompatible material.
On the right hand side, a
photograph from a different group
using a similar sort of bio materials
to produce an ear structure.
1:10
So how are these things regulated?
Well, as I said, in 2001 the
European Medicines Directive
came in and for the first time
it included human blood and blood
products as a medical substance,
and there was an implicit application
that somatic cells from humans
could be regulated as medicines.
And they talked about
them being substantially
modified, but no definition
of what substantial meant.
In 2004, when the clinical
trials directives was enacted,
the same term, 'substantially
modified somatic cells' arose.
And so these for
the first time could
be a trial medicine,
an Investigational
Medicinal Product, or IMP.
And this required the manufacturer
full pharmaceutical standards
of good manufacturing practice, GMP,
plus a manufacturing authorization
held by the manufacturer.
And in Europe, a qualified person,
the person with a status to legally
release these, was very
challenging at the time
because qualified
persons were pharmacists,
and they didn't come from
a cell therapy background.
In 2006, tissues and cells were
regulated by the European Union
under the Tissues
and Cells Directives.
And these were enacted
into UK law, meaning
that tissues and cells that are
used for transplantation purposes
are regulated.
And indeed those that are used as
starting materials to make ATMPs
are also regulated.
In 2007 those regulations
were published
and we had to start applying them.
And procurement of the
starting material in the UK
is regulated by the
Human Tissue Authority.
And in each member state there
is a different regulator,
and that requires a
license to procure.
The problem of
nonsubstantial manipulation
was finally defined with
some examples of what
nonsubstantial manipulation was.
But no definition of what
substantial manipulation is.
And this still comes down to a
decision by each member state.
Within the ATMP
regulations there was
this inclusion of a
strange clause called
the Hospital Exemption Clause.
Which allowed these
medicinal products
to be made one-off
in a non-routine basis,
no definition of non-routine,
and for non-clinical trials.
So these work for
patients in extreme need,
who needed treatment with
a therapy that was not yet
licensed and was
not in clinical trial.
And all of these regulations
were then combined together
in a rewriting of the European
Medicines Directive in 2009
to produce the new
Medicines Directive
which includes these advanced
therapy medicinal products.
So a quick race through the
regulation, if anybody is
interested obviously those
references are there, and one
can struggle through them.