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Log in page
Public access site: www.CITIsletStudy.org
CIT Status Report Nov. 2012 (pdf)
CIT-06 protocol (pdf)
CIT-07 protocol (pdf)
CIT Ancillary Studies policy (pdf)
CIT Site Qualification Criteria (pdf)
CIT Manufacturing Qualification Criteria (pdf)
Terminology Criteria for Adverse Events (TCAE)
Metabolic Testing synopsis (pdf)
Master Production Batch Record (Oct 2010) (.pdf)
Test Release Method SOPs
Type-1
Diabetes
Clinical
Trial
Background
Insulin-dependent
diabetes
mellitus,
or
Type-1
diabetes
(T1D) is
an
autoimmune
disease
characterized
by the
destruction
of the
insulin-secreting
beta
cells of
the
pancreas.
T1D is
difficult
to
control
with the
current
therapies
available,
and as a
result
patients
may
suffer
devastating
consequences
including
accelerated
cardiovascular
and
peripheral
vascular
diseases,
nephropathy,
retinopathy,
neuropathy,
oral
diseases
and
premature
death.
The
incidence
of T1D
appears
to be
increasing
worldwide.
Islet
transplantation
as a
therapy
for T1D
has been
an
important
focus of
governmental
funding,
and
significant
research
progress
has
occurred
in
recent
years.
Islet
transplantation
is a
procedure
performed
on
select
patients
with
Type-1
diabetes
to
replace
insulin-producing
cells
destroyed
by the
disease
and
restore
normal
blood
sugar
levels.
In
particular,
the
success
of the
"Edmonton
Protocol"
for
islet
transplantation
in
freeing
individuals
with T1D
from the
need for
insulin
therapy
has
established
islet
transplantation
as a
realistic
therapy
for
those
T1D
patients
whose
disease
cannot
be
effectively
managed
with
current
methods
of
insulin
administration.
Clinical
Islet
Transplantation
Trial
This
islet
transplantation
trial,
supported
by the
National
Institutes
of
Health (NIH),
National
Institute
of
Diabetes
and
Digestive
and
Kidney
Diseases
(NIDDK),
National
Institute
of
Allergy
and
Infectious
Diseases
(NIAID),
and
Juvenile
Diabetes
Research
Foundation
(JDRF),
will
continue
fostering
development
of islet
transplantation
as a
cure for
T1D.
Selected
patients
with
Type-I
diabetes
who have
received
a
successful
kidney
transplant
may be
excellent
candidates
for
islet
transplantation.
It is
the aim
of this
new
trial to
improve
methods
of
isolating
islets,
to
improve
techniques
for the
administering
those
transplanted
islets;
and to
develop
approaches
to
minimize
the
toxic
effects
of
immunosuppressive
drugs
required
for
transplantation. |
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