Cryoport, Inc., the world's leading cryogenic logistics company, announced it has expanded its contract with Stemedica Cell Technologies, Inc. (Stemedica) to provide cold chain logistics support for a phase II clinical trial to assess the safety, tolerability and preliminary efficacy of allogeneic stem cell-based therapies in the treatment of Alzheimer's disease.
Cryoport has worked with Stemedica since 2015, safely transporting ischemic-tolerant stem cells to clinical research institutions and accredited hospitals worldwide for use in preclinical and clinical studies. As the world's premier cryogenic logistics provider, Cryoport's extensive experience handling regenerative medicines, including stem cells and other important life sciences materials, ensures Stemedica's shipments are transported safely with fully documented chain of custody and chain of condition data. Under the terms of the agreement, Stemedica Cell Technologies uses the Cryoportal logistics management platform, proprietary Cryoport Express dry vapor shippers and condition monitoring systems to ship human stem cells from collection sites in the US to research centers in Georgia and California. Cryoport's end-to-end solutions provide Stemedica with the most advanced cryogenic logistics solutions anywhere, including constant monitoring during the entire logistics process.
Dr. Nikolai Tankovich, president and chief medical officer of Stemedica, commented, "We recently demonstrated, through preclinical and overseas clinical trial data that intravenous administration of stem cells resulted in a delay of accumulation of plaque formation and also in the reduction of plaque in an animal Alzheimer's model. This phase II trial will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer's disease and will bring us closer to developing a stem-cell based treatment for humans. Using Cryoport's validated cold chain solutions to maintain the integrity of our product line and ensure reliability of delivery to patients across the US is essential to the validity of the trial. Having worked with the team at Cryoport previously, we have no doubt that they are the right partners to support this trial."
Jerrell Shelton, chief executive officer of Cryoport, Inc., stated, "Our logistics solutions help mitigate risk and ensure the safe, reliable global distribution of frozen biologic materials whether in pre-clinical, phase I, phase II, phase III clinical trials or commercial. Fostering strong relationships with innovative life sciences companies, such as Stemedica, is important to Cryoport and serves as an example of ongoing opportunities as new trials and product launches take place in the industry. We are proud to have worked with Stemedica since 2015 as a trusted partner distributing its ischemic-tolerant stem cell products to its wide client base within the research community. Stemedica has now evolved to the point where it is conducting a phase II clinical trial and we are very pleased to scale our agreement with them to support their work fighting Alzheimer's disease."
Cryoport currently supports more than 78 clinical trials worldwide. The company's clinical trial clients include ImmunoCellular Therapeutics, Kite Pharma, Gradalis and Perseus PCI.