Saturday, January 08, 2005

Introduction

In the most recent development in this matter, on January 6th the FDA denied an application for 'emergency IND' authorization to resume cord blood transfusions to an ALS patient who had previously benefited from cord blood transfusions with no ill effects.

This denial ignored a request by four U.S. Congressmen and one U.S. Senator for the FDA to give its prompt, humane approval.

The following presents the history of this matter.

After learning of positive effects gained through transfusions of whole, untreated human umbilical cord blood in mice with an animal model of ALS, several dozen American patients and their families wished to try this approach towards slowing this fatal, disabling disease that has no cure, no effective treatment, and for over 95% of patients no known cause.

The following slides present email correspondence between Mrs. Marisabel Alcalde, daughter of an ALS patient, and Ms. Lorrie Harrison McNeil, Director of Consumer Affairs for FDA’s Center for Biological Evaluation. The purpose of this contact was to determine the FDA’s position regarding the use of human umbilical cord blood to treat Mrs. Alcande’s father.

Click the following slides to enlarge.