The First Orally Delivered Cell Therapy for the Treatment of Inflammatory Bowel Disease

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Grant Award Details

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Human Stem Cell Use:
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Progress Reports

Reporting Period:
Year 1

Grant Application Details

Application Title:

The First Orally Delivered Cell Therapy for the Treatment of Inflammatory Bowel Disease

Public Abstract:
Research Objective

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.
Statement of Benefit to California:
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.