Grant Award Details
- To complete activities leading to the declaration of a single oral cell therapy for inflammatory bowel disease [IBD] comprised of encapsulated adult mesenchymal stem cells.
Grant Application Details
- The First Orally Delivered Cell Therapy for the Treatment of Inflammatory Bowel Disease
The goal of this project is to develop the first ORAL cell therapy as a breakthrough treatment for inflammatory bowel disease [IBD].
We engineered a new way to deliver cells ORALLY instead of by injection. In doing so, we will better reach the inflamed tissues and provide a much-needed new treatment for those afflicted with IBD.
Major Proposed Activities
- We expect that from these studies an optimal dose and dosing regimen for the oral cell therapy will be established and will help build our clinical target product profile.
- We expect that we will further characterize the anti-inflammatory mechanism of action of the oral cell therapy.
- We will also establish the biodistribution of the orally delivered cells to further gain support for advancement of our breakthrough IBD therapy towards clinical studies.
- We will collect all of the information needed to request an FDA INTERACT meeting.
The current standard of care works in only a third of the inflammatory bowel disease [IBD] patients. IBD incidence is growing in California and elsewhere, and there is no known cure. Cell-based therapy is considered the next generation treatment approach for IBD. An orally delivered cell therapy simultaneously solves some of the hurdles of this promising industry while offering a much needed novel therapeutic to IBD patients.