First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-Chapter 6: patient selection for pilot clinical trials of islet xenotransplant

Author:

Hering Bernhard J.1,O'Connell Philip J.2

Affiliation:

1. Department of Surgery; Schulze Diabetes Institute; University of Minnesota; Minneapolis MN USA

2. The Centre for Transplant and Renal Research; Westmead Millennium Institute; University of Sydney at Westmead Hospital; Westmead NSW Australia

Funder

National Institutes of Health

National Health and Medical Research Council of Australia

Juvenile Diabetes Research Foundation

Publisher

Wiley

Subject

Transplantation,Immunology

Reference130 articles.

1. Clinical porcine islet xenotransplantation under comprehensive regulation;Matsumoto;Transplant Proc,2014

2. U.S.Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Xenotransplantation/ucm074354.htm

3. European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) Guideline on Xenogeneic Cell-Based Medicinal Products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/12/WC500016936.pdf

4. Health Research Council of New Zealand Gene Technology Advisory Committee Guidelines for Preparation of Applications Involving Clinical Trials of Xenotransplantation in New Zealand http://www.hrc.govt.nz/sites/default/files/GTAC%20Guidelines%20for%20Preparation%20of%20Applications%20Involving%20Clinical%20Trials%20of%20Xenotransplantation%20in%20NZ.pdf

5. U.S.Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for Industry http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM359073.pdf

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