In the collaborative effort, the department is using a prototype of CardianBCT's Quantum Cell Expansion System to reproduce human bone marrow stromal cells in an automated, sealed environment. The collaboration is part of the Trans-NIH Bone Marrow Stromal Cell Transplantation Center, created in 2008 to facilitate the use of clinical-grade bone marrow stromal cells prepared using procedures known to maintain their biological activities and to assist investigators in the preparation of protocols that utilize such cells. The trans-NIH group is co-coordinated by Dr. Pamela Robey of the National Institute of Dental and Craniofacial Research and Dr. Harvey G. Klein, chief of transfusion medicine at the Clinical Center.
Bone marrow stromal cells, or mesenchymal stem cells, form the supportive structure in which the cells that produce human blood reside and play a part in the repair of tissue and bone formation. Patients with autoimmune disorders, acute host-versus-graft disease, and need for bone formation after surgery could benefit from the transfusion of these cells.
"The NIH Clinical Center is dedicated to finding new and more effective ways to treat human diseases and disorders, and this collaboration utilizing bone marrow stromal cells to improve stem-cell studies offers promising opportunities in support of clinical research," said Clinical Center Director Dr. John I. Gallin.
Current methods used to expand cells are manual, labor intensive, and complex, which can limit the ability to provide stem cell therapy to a large number of patients. Cell processing laboratory staff take a piece of bone or bone marrow aspirate, a sample of the liquid bone marrow portion, and replicate the stromal cells by growing them in flasks and transferring to larger flasks as they grow in number. Staff must monitor the cells' development and move them by hand.
As an integrated, closed system, the cell expansion system improves efficiency of the stem cell growth process-allowing for larger scale manufacturing of cells with less risk of contamination and better control of the process. The new system produces cells in a sealed container using bioreactor technology, which circulates fluid through cartridges and automatically loads the cells into the cartridge, feeds the cells, and harvests the cells.
"Having a technology that enables the production of large quantities of cells in a reproducible, robust and closed system manner is a key to being able to move forward with the clinical validation and subsequent implementation of cellular therapies," said Klein.
Until the machine's output is verified as comparable to the expanded stromal cells created through traditional methods, the Department of Transfusion Medicine will continue to make cells for patients using the traditional flask method. Within six to nine months, cells produced using the prototype should be ready for treatments, Klein said.