The Approach
MSCs can function as therapeutic modalities in both tissue regeneration and immune modulation due to their ability to differentiate into different tissue types, while also releasing immunomodulating proteins, surface markers, and antimicrobial peptides. The genome of MSCs can be edited using viral vectors encoded for genes of interest to implement a more robust therapeutic response. For these reasons, MSCs are being investigated as cellular therapies.
The Challenge
MSCs are inherently heterogeneous, coming from a multitude of tissue types. Understanding the appropriate origin, and sorting for the appropriate subset of MSCs for the desired therapeutic application can be challenging. Characterizing and maintaining the stemness of MSCs, while also expanding the cells for clinical use, presents an additional hurdle. Finding defining characteristics that are consistent with cell capabilities and function in vivo, and also specific to that function has proven to be a challenge with undifferentiated MSCs.
At Theragent, we bring to bear the appropriate clean room facilities and equipment to execute your MSC project.
Over 400 clinical trials have involved the use of MSC therapies. MSCs are being tested in regenerative medicine, autoimmune disorders, inflammatory diseases, oncology, and graft versus host disease. MSCs have been in use clinically for over 20 years and have been tested in all phases of clinical trials but have yet to show the significant clinical response seen with immunotherapies.
At Theragent, we bring to bear the appropriate clean room facilities and equipment to execute your MSC project. We offer both product and process development, and analytical method development, that can be followed by clinical production with the requisite execution of analytical methods in-house, drastically shortening product release timelines, while ensuring appropriate quality control. Reach out to us to learn more about how we can accelerate your MSC project from pre-clinical development through clinical trials.