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Administrative and Bioinformatics
Coordinating Center (ABCC)
City of Hope National Medical Center
and Beckman Research Institute
Division of Information Sciences
1500 East Duarte Road
Duarte, CA 91010-3000
Grant No. 1 U42 RR17673 |
For information about
the consortium and how to access its resources, please contact:
Project Administrator
Rebecca Nelson, Ph.D.
626-359-8111, ext. 64040; Fax: 626-471-7106
E-mail:
rnelson@coh.org
ABCC Director and Principal Investigator
Joyce Niland, Ph.D.
626-359-8111, ext. 63032; Fax: 626-301-8802
E-mail:
jniland@coh.org
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The Islet Cell Resource (ICR) Centers comprise an interactive
group of 10 academic laboratories charged with the pursuit of
three major goals: provide human pancreatic islets to eligible
investigators for use in FDA- and IRB-approved clinical trials
of transplantation in patients with type 1 diabetes mellitus;
optimize the harvest, purification, function, storage, and
shipment of islets while developing tests that both characterize
the quality and predict the effectiveness of those islets
transplanted into patients with type 1 diabetes; and provide
research-grade pancreatic islets for basic science studies.
Investigators may request clinical-grade islets for qualified
transplantation protocols and research-grade islets for qualified
basic science studies. Clinical-grade islets are distributed to
eligible clinical investigators upon receiving a favorable review
and subsequent approval by the ICR Steering Committee (SC).
Research-grade islets are distributed to eligible basic science
investigators upon receiving a favorable review by a subcommittee
of the ICR SC. Preference is given to investigators who have
peer-reviewed, NIH-funded research support.
Applications to request ICR center resources can be
obtained from the Project Administrator (see above). Applications for
clinical-grade islets must be received by February 15 and August 1.
The ICR SC will review, assign priority scores, and rank applications
based on the scientific merit and feasibility of the proposal,
including the clinical and preclinical data leading to the proposed
clinical trial; the suitability and technical feasibility of the
proposed approach; the capacity of the investigator to enroll
patients in the proposed study; the availability of the required
clinical and laboratory support; the planned statistical evaluations
of the clinical and laboratory endpoints; the technical, legal, and
ethical issues of the proposed protocol; the likelihood of success for
the proposed approach in relationship to other clinical trials; the
resources required for the proposed trial, including sources of
funding for safety testing, clinical studies, data management, and
post-therapy laboratory and clinical evaluations; the current status of
the proposed protocol; efforts to ensure that NIH guidelines for patient
safety, and minority and gender representation in the clinical trial are
satisfied; and available support for the project.
Applications requesting research-grade islets will
be reviewed monthly by a subcommittee of the SC.
Applicants will be notified of approval or disapproval
within 60 days. Recommendations will be based on scientific
merit and feasibility of the study; ICR resources required;
justification for the number of requested islets; suitability
and technical feasibility of the study; availability of the
required laboratory support; technical, legal, and ethical
issues of the proposed study; resources required for the study;
current status of the study; and all sources of support for the project.
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Special Services, Facilities, or Instruments
- Islet Cell Resource Centers: Generate human islet cells and perform
relevant tests in facilities compliant with Good Manufacturing Practice
(GMP)/Good Laboratory Practice (GLP) guidelines.
- ABCC: Administrates the Consortium, acquires data, and performs
biostatistical reviews to meet ICR goals.
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