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Public access site: www.CITIsletStudy.org
CIT Status Report Nov. 2014 (pdf)
CIT-06 protocol (pdf)
CIT-07 protocol (pdf)
CIT-07 Statistical Analysis Plan (pdf)
CIT Publication Policy (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 (Aug 2011) (.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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