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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous ex vivo expanded polyclonal CD4plusCD25plusCD127 lo/- FOXP3plus regulatory T cells (CELZ-101)
Date Designated: 03/05/2024
Orphan Designation: Prevention of allograft rejection in patients undergoing pancreatic islet cell transplantation
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Creative Medical Technology Holdings, Inc
211 E. Osborn Rd.
Phoenix, Arizona 85012
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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