IND - Investigational New Drug

Under Investigational New Drug status, the FDA regulates those umbilical Cord Blood transplants that are received from unrelated donors. It is therefore, the public Cord Blood banks should file an IND application.

Many medical communities consider the IND status of unrelated umbilical Cord Blood transplants as interference to their vast use for those transplant patients that cannot get a matching adult donor. Considering this, in the month of April 2005, the Institute of Medicine published a report from the Committee on Establishing a National Cord Blood Stem Cell Bank Program. Among the most important findings of the IoM Report was Recommendation 4.4 reading: “The Food and Drug Administration should move promptly to establish a system of licensure of cord blood units intended for clinical transplantation. As an interim measure until a licensure process is established, all banks participating in the National Cord Blood Stem Cell Bank Program should operate under an investigational new drug application.”