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Will provide cold chain logistics for clinical trial of SEPCELL for the treatment of sepsis
February 9, 2018
By: Tim Wright
Editor-in-Chief, Contract Pharma
Cryoport, a provider of temperature controlled logistics for the life sciences industry, is partnering with TiGenix as it conducts its SEPCELL phase Ib/IIa clinical study. The study will evaluate the safety and efficacy of expanded Cx611 allogeneic adipose‐derived stem cells (eASCs) for the treatment of sepsis in adult patients with severe community‐acquired bacterial pneumonia and admitted to the intensive care unit. TiGenix is a developer of allogeneic stem cell therapies targeting autoimmune diseases and said it aims to recruit 180 patients in at least 50 centers for the randomized double-blind placebo controlled SEPCELL study. As a part of the agreement between the companies, Cryoport will provide global logistics support, observing international best practices for transporting cryogenically preserved clinical commodities. Cryoport’s suite of unique temperature controlled logistics solutions includes its Cryoport Express shippers, SmartPak II Condition Monitoring System, Cryoportal Logistics Management Platform and 24/7/365 logistics support. These capabilities will enable TiGenix to monitor its shipments and track the conditions and location of its stem cells while in transit, around the clock. “Sepsis is a potentially life-threatening complication of infection, which can lead to systemic inflammation and, in the worst cases, organ failure,” said Jerrell Shelton, chief executive officer, Cryoport. “The emergence of increasingly drug-resistant bacteria, alongside aging populations around the world, is driving a growing number of sepsis cases. TiGenix aims to leverage the anti-inflammatory properties found in stem cells to develop a novel treatment for sepsis, using its allogeneic (donor derived) stem cell platform, Cx611. We are, indeed, proud to be providing logistics support for this exciting clinical trial.”
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