Ex vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients
Abstract
The main goal of our project is to culture human hematopoietic stem cells to produce enough megakaryocytes (MK) to be transfused to patients as a supplement to the conventional stem cell transplant. The transfused megakaryocytes will generate platelets, eliminating the need for repeated platelet transfusions post-transplant. Growth factors (GF) are needed to grow and expand MK using an ex vivo expansion protocol. We planned, as described in our original proposal, to use GF developed by Searle. Searle was bought by Pharmacia. This left us without a source of the necessary GF for our clinical trial. We had to seek alternative sources for our studies. Fortunately, we were able to obtain clinical grade TPO and IL-3 through R&D and Flt3-L through Immunex, and we reported last year our successful small-scale study. At the time that we requested permission to change the source of GF for the scale-up study and the clinical trial, the grant and clinical protocol underwent re-review by the Army Human Subject Board. They requested that a second clinical protocol be written and submitted for review prior to initiating the scale-up protocol. This resulted in considerable delay. We describe in the present report the successful scale-up results. We were fortunate to have rapid review by the FDA to obtain an IND for the process and approval of the clinical protocol. These delays prevented us from adhering to our estimated timeline. Our first patient will be enrolled this week (10/8/2001). We are planning to apply for a supplementary grant period of one year to finish our clinical trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2001
- Accession Number
- ADA400103
Entities
People
- Isaac Cohen
- Jane N. Winter
Organizations
- Northwestern University