CLINICAL TRIAL FUNDING INITIATIVE - NATIONAL STEM CELL FOUNDATION OF
AUSTRALIA
The NSCFA is exploring ways to initiate and support properly constituted clinical trials of stem cell-based
treatments in Australia. Whatever the source of cells to be utilised, we believe strongly that SC therapies
need to be soundly based on evidence, not only of safety but efficacy for the condition under consideration,
before being promoted to the public as therapy. We also recognise the challenges in mounting appropriate
clinical trials. It may be possible to promote more direct links between donors with identified interest in the
target illness on one hand, and research groups planning to transition potential Stem Cell based therapies
from pre-clinical to clinical trial status on the other. While there is absolutely no guarantee that such an
approach would be fruitful, the Foundation wishes to see if it might work to achieve its aims and the
therapeutic goals of stem cell research teams. We would like to hear from stem cell research groups who
believe their projects have human therapeutic potential and are ready to enter clinical trial. If you have data
that fall into this category and would like to join us in assessing whether the approach might work, please
complete the brief pro forma below.
Please include only non-confidential information in your responses
1. Name of institution/institute and
department
2. Names of leading investigator and other
principal scientists and clinicians who
would be involved.
3. Specify the nature of the cellular product
you propose to submit to trial, including
the derivation and lineage specificity of the
cells.
4. What clinical conditions(s) are you
proposing to treat?
5(a) What treatments are currently used for
this condition?
5 (b) Comment on the efficacy of current
treatments
6. What particular age group (if any) would be
most likely to benefit from successful
treatment?
7. Would your trial include subjects of both
sexes?
8. List disease-expert support staff – medical, nursing, paramedical, - and facilities and
diagnostic services that will be available to you.
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9. Have you or others obtained proof of principle data that support the effectiveness of your
proposed cellular treatment in an animal model of the disease?
10. Are there any existing data relevant to your treatment from other centres around the
world?
11. Do you have approval for your proposed
treatment trial from your HREC? If not, has
the study been submitted to the HREC?
12. What is the estimated duration of the
study?
13. Have you discussed partnerships with commercial or academic entities who might be able to
finance your studies? These could be based in Australia or overseas. Have you any plans to
make such approaches?
14 Please indicate how a grant or donation from a NSCFA funding partner would assist in the
conduct of your trial ( Note that funding options may include an item of equipment, partial
salary support for a research assistant/ data manager etc.)
The completed questionnaire should be no more than 3 pages.
Please address any questions and send your completed Proforma by Friday November 6, 2015 to
Ms Julia Mason
Executive Officer
National Stem Cell Foundation of Australia
Email: jmason@stemcellfoundation.net.au
The replies will be reviewed by an expert panel who will select proposals for approaching potential donors.
We expect this will not be a long process and we’ll communicate the outcome to you as soon as possible.
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