Ex Vivo Expanded (EVE) Megakaryocytes (MK) for Supportive Care of Patients with Breast Cancer Hematologic Malignancies: A Phase I/II Clinical Study
Abstract
The main goal of this project is to culture human hematopoietic stem cells in the presence of growth factors to produce autologous megakaryocytes (MK) to be transfused into patients as a supplement to the conventional stem cell transplant. The purpose of the clinical trial is to determine whether the transfused MK generate platelets in vivo in great enough numbers to reduce or eliminate the need for repeated platelet transfusions following high-dose chemotherapy and autologous stem cell transplant.. Using the cocktail of growth factors thrombopoietin (from R&D), IL-3 and Flt3-L, the results obtained with our first patient are very encouraging with platelet recovery occurring at day 6 post-transplant (26,000/mm3). This unusual rapid recovery must be attributed to the ex vivo expanded cells. Midway into processing our MK cultures, we and other groups were notified by the FDA to avoid using thrombopoietin obtained from R&D because of concerns regarding the purification process. This new obstacle caused us to abort the transplant of ex vivo expanded MK for the second patient. We were fortunate to find an alternative form of clinical grade of thrombopoietin from Pharmacia which was approved by the FDA. We will reopen the clinical trial in two weeks. Despite the delays, we anticipate completing our project within the period of time covered by the no-cost extension of our grant.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2002
- Accession Number
- ADA410780
Entities
People
- Isaac Cohen
- Jane N. Winter
Organizations
- Northwestern University