ThawSTAR® Clinical Early Adopter Program
MedCision is pleased to announce a new program to help companies and investigators de-risk thawing of cell therapies in early stage clinical trials. Read more to find out how to apply.
Unique technical challenges in cell therapy
Clinical trials involving live cells represent a quantum leap in complexity and risk for sponsors and investigators. Trial success can be adversely affected by variations in sample handling. Typical Phase 2 or Phase 3 trials with multiple clinical sites, investigators, and operators introduce huge potential variability into the trial protocol. All of the execution, effort, and money that goes into production of the therapy can be undone with errors in the last step prior to administration: thawing.
How does ThawSTAR® automated cell thawing platform help?
MedCision’s ThawSTAR® thawing system utilizes a patent-pending adaptive sensing technology that incorporates temperature sensing and algorithm-based thawing to deliver a consistent and reproducible thaw profile and endpoint to each vial.
The ThawSTAR® instrument helps eliminates variability prior to therapy administration to a patient by critical control of vial thawing. This serves to remove operator error and day-to-day variations within a site as well as site-to-site variation across multiple clinical centers in a single trial. The controlled and automated cell thawing provided by the ThawSTAR system eliminates variability that could have a detrimental effect on the safety and efficacy of the cell therapy product. The result is a significant reduction in cell handling risk in a clinical setting.
The ThawSTAR EAP program from MedCision
MedCision is offering a select number of companies and institutions undertaking clinical testing of cell therapies the opportunity to standardize and de-risk their clinical thawing efforts. Under this early adopter program, MedCision will provide ThawSTAR instruments for the duration of your trial phase as well as full training and technical support, all at no cost.
We look forward to making your cell therapy trials a success!
ThawSTAR® Master File
The Master File for all models of the ThawSTAR® Automated Cell Thawing System has been registered to the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) under the reference number MAF2643. If you are submitting an investigational new drug (IND) application or a biologics license application (BLA) to the U.S. FDA, and need a cross-reference letter to our Master File, please contact us at firstname.lastname@example.org.
For Research Use Only
The ThawSTAR® System is for laboratory research use only. Any intended use for diagnostic purposes, direct transfusion, or in the production of therapeutic product(s) or vaccines(s) may require advance regulatory clearance which is the sole responsibility of the user, as this is not a medical device that has undergone medical device registration, clearance, or approval by the U.S. Food and Drug Administration (FDA), European Union, Health Canada, or the Australian Therapeutic Goods Administration.
For more information and details on how the program works, please contact us at email@example.com or use the form below.