IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System Guidance for Industry and FDA Staff March 2014
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, the Center for Biologics Evaluation and Research (CBER), FDA, are providing advice to you, potential sponsors (e.g., cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators), to assist in the submission of an Investigational New Drug Application (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood)1 , when such HPC, Cord Blood units are not licensed in accordance with Title 21 of the Code of Federal Regulations Part 601 (21 CFR Part 601), and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alternative treatment available. If unlicensed HPC, Cord Blood units are made available for clinical use, they must be distributed under an IND meeting the applicable requirements in 21 CFR Part 312.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2009-D-0490.