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New Approach to Temperature Control in Cell Therapy Clinical Trial

Published: Wednesday, April 23, 2014
Last Updated: Wednesday, April 23, 2014
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CoolCell® cell freezing device and CoolBox™ ice-free cooling workstations chosen to support handling and processing of investigational cell therapy product in landmark clinical research trial.

BioCision, LLC has announced that several of the company’s products used to support temperature control, as well as processing and handling of cell therapy products, will be used in a Phase IIb clinical trial conducted by TxCell.

The trial will investigate the use of Ovasave®, an antigen-specific regulatory T (Ag-Treg) autologous cell-based immunotherapy for the treatment of patients with moderate to severe refractory Crohn’s disease.

In the Ovasave® Phase IIb trial, TxCell, which specializes in developing cell-based therapies for chronic inflammatory disease, will use the BioCision CoolCell® passive cell freezing device as the method for freezing Ag-Treg cells.

In previous Ovasave® trials, TxCell used electronic programmable controlled-rate freezers (CRF) to manage the cell freezing temperature, however, the CoolCell® containers will be used for this trial as they provide a cost-effective alternative to the CRF, with the same freezing efficiency and post-thaw outcomes, while also being significantly less expensive to deploy and maintain.

Regulatory T cells are extremely sensitive and changes in efficacy can occur with variations in temperature and handling regimes. TxCell determined that the BioCision products are suitable for use in their authorized Class B manufacturing facility and, therefore, also chose the BioCision CoolBox™ ice-free cooling workstations to ensure standardized and reproducible handling of the cells during manufacturing. The proprietary CoolBox ice-free cooling technology enables asceptic workflow and uniform sample handling, minimizing risk of temperature fluctuation and contamination.

“BioCision products can help researchers in cellular and regenerative medicine achieve the highest possible standards in sample processing and handling, especially as it relates to standardizing the cell cryopreservation workflow,” said Rolf Ehrhardt, MD, PhD, BioCision CEO. “We are pleased that TxCell has selected BioCision products for the Ovasave® Phase IIb trial, and we look forward to working them and other leaders in regenerative medicine and cell therapy research to advance these promising therapies.”

In October 2012, TxCell has announced publication of complete results of the Phase I/II CATS1 study and presented data from a one-year extension of the study supporting the long term tolerability of Ovasave® in the treatment of patients with moderate to severe refractory Crohn’s disease. The development of Ovasave® involves a proprietary manufacturing process where Ag-Treg cells are isolated from the whole blood of the patient and are then expanded ex vivo before reinjection into that same patient.

“As we advance our promising clinical research program for Ovasave® to a Phase IIb trial, the BioCision product portfolio and technology platform present the ideal range of capabilities and quality standards necessary to help us maintain the essential levels of standardization and control we need to be successful,” said TxCell Arnaud Foussat, Vice President Research and New Products at TxCell.

TxCell will present additional details on the use of CoolCell® containers for cell freezing on April 24, 2014 during Poster Session 1 at the 20th Annual Meeting of the International Society of Cellular Therapy in Paris. The abstract is titled, “Use of a low-cost passive freezing device in the effective cryopreservation and recovery of human regulatory T-cells for use in a cell therapy trial.”

The authors evaluated CoolCell containers as an alternative to the classical controlled-rate freezer, resulting in a new standardized method of cell therapy product cryopreservation and marking an important milestone in the ultimate use of cell therapy in the clinic.

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