Aastrom Bioscience Boosts Stem Cell Production from Cord Blood
In April of this year, a publication in the medical journal Bone Marrow Transplantation reported case studies of patients with chronic myelogenous leukemia (CML) who received cord blood cells produced in Aastrom's CB-I Therapy Kit. These patients showed successful recoveries of normal blood and immune system function with no evidence of disease relapse.
The CB-II Therapy Kit process used in the present studies involves growing the cells for 12 days in cell culture under controlled medium-exchange conditions. Various cell populations were monitored pre- and post-expansion, including cells that express CD34, which identifies hematopoietic stem cells. This cell population expanded 9.5-fold, while the total nucleated cells increased 8.3-fold. The process used cord blood that had been previously stored using standard cryo-preservation methods as the starting cell source, and involved no cell selection or other processing steps. These evaluations were performed using the AastromReplicell System and starting cell quantities similar to those employed in previous clinical trials using the CB-I Therapy Kit. The end result is that patients could receive the equivalent of approximately 10 transplant doses of cells compared with the company's current procedure.
This discovery could provide cancer patients undergoing transplantation with significantly higher doses of stem cells, potentially enhancing the probability of a successful outcome. Using this product may also increase the number of patients that can be transplanted from a single cord blood donation. Aastrom intends to initiate a new CB-II Therapy Kit development program and initiate a feasibility study for the new stem cell production procedure that will become part of the AastromReplicell System product line.
Aastrom has pioneered technologies for growing human cells ex vivo. Its patents provide coverage for human stem cells produced ex vivo from cord blood, bone marrow, or blood under culture conditions employing medium-exchange or perfusion (U.S. Patent #5,437,994; #5,646,043; #5,670,147), but can also be applied to a number of emerging cell therapies being developed for other types of human cells. The new cord blood stem cell expansion process is based on Aastrom's patented medium-exchange technology, which the company believes is the only approach that has succeeded in growing these key therapeutic cells.
"The use of regulated medium-exchange in growing human stem cells and other tissues is continuing to emerge and allows unique results and capabilities," said R. Douglas Armstrong, president and CEO of Aastrom Biosciences Inc. Armstrong continued, "Further, this approach allows large-scale batch production of human cells, which are becoming increasingly important therapeutic agents. Our new discovery will… further improve the flexibility, availability and, hopefully, the overall effectiveness of cord blood stem cell transplants by offering a 10-fold greater amount of potentially therapeutic cells."
The AastromReplicell System consists of an instrumentation platform designed to operate a family of patient-specific cell therapy kits to produce cells for a broad range of therapeutic applications. Each therapy kit is a single-use consumable product that is tailored to the specific cell type desired for therapeutic use. Aastrom has developed two such therapy kits including the CB-I Therapy Kit and the SC-I Therapy Kit for the production of bone marrow derived stem cells. Aastrom also recently announced the initiation of a development program for its OC-I Therapy Kit, intended for the production of bone-forming cells.
For more information: Todd E. Simpson, VP of Finance and Administration, Aastrom Biosciences Inc., 24 Frank Lloyd Wright Dr., Lobby L, Ann Arbor, MI 48106. Tel: 734-930-5777.