Funded by the MRC. AUTOLOGOUS CHONDROCYTE TRANSPLANTATION/IMPLANTATION VERSUS EXISTING TREATMENTS ISCRCTN 48911177. NEWSLETTER April 2008 Issue 14. Protocol amendments Good news! After a lengthy process the MRC and ethics have approved the
Funded by the MRC
AUTOLOGOUS CHONDROCYTE TRANSPLANTATION/IMPLANTATION
VERSUS EXISTING TREATMENTS ISCRCTN 48911177
NEWSLETTER April 2008 Issue 14
Good news! After a lengthy process the
MRC and ethics have approved the
following changes to the protocol:
An extension to the recruitment period
of up to the end of 2009 to recruit at
least 480 patients.
Patella lesions can now be treated in
Osteochondral defects can now be
treated in the trial. Any OCDs
involving more than 3 mm of bone loss
must be grafted but the type and
timing of bone graft is down to
surgeons’ choice since there is a lack of
evidence to support any one particular
As you know MACI is already a cell
grafting option in the trial. A further
matrix version of ACI called Chondron
in which the cells are suspended in a gel
at the time of surgery is now an option as
a subrandomisation against MACI.
Surgeons choosing this option must still
select a standard treatment as part of
the main randomisation.
Number of patients randomised Total: 208
Recruitment / new centres
Thanks to everyone who has contributed to
getting us past the 200 mark for
recruitment. Just another 280 to go!
Fortunately we anticipate a large increase in
the rate of recruitment now that Stanmore
is ready to start.
Fairfield General Hospital in Bury is our
latest centre to begin recruitment and
further centres are being set up.
A workshop for new surgeons is being
planned to take place at Oswestry on either
the 3rd or 10th June (or both days depending
on numbers). If you are new to the trial or
know of colleagues who would like to attend
please contact Heather. New co-ordinators
and assessors are also welcome. The
workshop involves talks on surgical
techniques and the ACTIVE protocol;
observing a 2nd stage ACI in theatre with
Prof Richardson; and a hands-on
practice of cell-grafting techniques using
cow stifle joints.
Each co-ordinator will be sent a pack of the latest version (v 3.1) of the Patient Information Leaflet. A further version (3.2) is to be used by Stanmore and any other centres who decide to use Chondron. New Patient Entry Forms and Treatment Records will be sent out shortly to include the above protocol changes. Please continue using your existing forms until the new ones arrive. If you are entering patients with an OCD or patella lesion please notify Heather first.
A UK-ICRS conference is planned for the Autumn, to take place at Stanmore, led by Prof. Dave Marsh and Prof. George Bentley – date to be confirmed.
The latest version of the protocol can be downloaded from the website under “study documents” along with a summary of all the protocol amendments. A hard copy will be sent to every centre in due course.
ACTIVE Trial Manager
Tel: 01691 404142
Happy at work in St. Olavs Hospital, Trondheim – from left to right: Bente Johansen (co-ordinator) Ingrid Solhjem (assessor) and Berit Wenaas (admin assistant) looking very organised with their ACTIVE files