NIAID, NHLBI seeking institutions, individuals to conduct clinical trials in pediatric organ transplantation.

Two prominent federal agencies are seeking applications from institutions and individuals interested in conducting clinical trials together with a "principal investigator" on pediatric organ transplantation.

The National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health are looking for new and/or competing applications from a consortium of investigators to conduct multi-site clinical trials or observational clinical studies with associated mechanistic studies in children up to 20-years old who have undergone heart, lung, small intestine, liver, and/or kidney transplantation.

Pediatric patients under the age of 21 represent 2% of the 100,000 individuals in the US on the waiting list for a transplant. The agencies point out that while children are exposed to the same pharmacologic and surgical interventions as adults, they may have unique needs and characteristics including immunologic immaturity, naivete to multiple infectious pathogens, differences in drug metabolism, and issues related to physical growth and psychological development. Because of their small numbers, clinical studies are difficult to conduct which requires a focused initiative to address their specific needs.

"The Clinical Trials in Organ Transplantation in Children (CTOT-C) program will support a cooperative, multi-institutional consortium for the conduct of interventional or observational clinical studies with associated mechanistic studies, to further our understanding of and ultimately reduce the immune-mediated morbidity and mortality of pediatric transplant recipients," the agencies said in the announcement of the funding initiative.

The studies are designed to:

(1) evaluate new therapies and approaches to overcome immunologic barriers to graft acceptance and/or long-term graft and patient survival;

(2) evaluate novel approaches to treatment or prevention of immune mediated complications in pediatric transplant patients;

(3) investigate underlying mechanisms of action for pathological processes and therapeutic regimens under evaluation; and

(4) develop diagnostic tests and critical biomarkers that will facilitate routine surveillance, early diagnosis and ongoing monitoring of those processes that contribute to post-transplant morbidity and mortality.

The agencies stress they will not support the following:

(1) studies of hematopoietic stem cell transplantation (HSCT) unless HSCT is a component of a study of organ transplantation;

(2) studies of islet cell transplantation for treatment of type 1 diabetes;

(3) studies involving animal models unless they are directly linked and necessary to achieve specific aims of a clinical trial; and

(4) studies involving xenotransplantation.

The agencies said examples of clinical trials and observational studies include, but are not limited to:

*Pre-existing immunologic barriers (e.g., anti-HLA antibodies or ABO incompatibility) to successful transplantation;

*Chronic allograft destruction after organ transplantation (e.g., obliteration bronchiolitis, cardiac allograft vasculopathy);

*Immunomodulatory interventions targeting innate immunity and/or autoimmunity in recipients;

*New, less toxic immunosuppressive agents or regiments.

The NIAID and NHLBI intend to commit approximately $3.5 million in FY 2008 to fund three to four new and/or competing continuation grants in response to their call for applications.

Eligible institutions in to request funding include for-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State government; units of local government; eligi le agencies of the Federal government; domestic institutions; foreign institutions are not eligible to apply as the primary applicant but may enter into a consortium with a domestic institution as the primary applicant.

Principal investigators must be established in the field of pediatric transplantation as evidenced by clinical experience and relevant publications.

Information on applying for RFA-A-07-006: Clinical Trials in Organ Transplantation in Children is available online at: http://grants.nih.gov/grants/guide/rfao-files/RFA-A-AI-07-006.html