Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy

Darin J Weber; Richard D McFarland; Ilan Irony

doi:10.1097/00007890-200212270-00034

Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy

Transplantation. 2002 Dec 27;74(12):1816-20. doi: 10.1097/00007890-200212270-00034.

Authors

Darin J Weber¹, Richard D McFarland, Ilan Irony

Affiliation

¹ Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA. weberd@cber.fda.gov.

PMID: 12499908
DOI: 10.1097/00007890-200212270-00034

Abstract

The Food and Drug Administration has seen a significant increase in investigational new drug (IND) applications for the use of allogeneic islets of Langerhans to treat type 1 diabetes mellitus. The current regulatory framework for clinical use of allogeneic islets of Langerhans is described. In addition, expectations and considerations for information to be included in the manufacturing, preclinical, and clinical sections of an IND for allogeneic islets of Langerhans to treat type 1 diabetes mellitus are discussed.

Publication types

Review

MeSH terms

Diabetes Mellitus, Type 1 / surgery*
Drug Approval / legislation & jurisprudence*
Humans
Islets of Langerhans Transplantation / legislation & jurisprudence*
Islets of Langerhans Transplantation / standards
Transplantation, Homologous
United States