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# FDA Hold on Vertex Cell Therapy for Diabetes
- URL: https://www.fdaweb.com/fda-hold-on-vertex-cell-therapy-for-diabetes/
- Published: 2022-05-02T12:00:00.000Z
- Updated: 2026-09-14T17:42:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151723

FDA has placed a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with Type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. The agency made a determination that there is insufficient information to support dose escalation with the product, according to the company.

Vertex was caught off guard when FDA placed the hold because the company had submitted data from two patients dosed at half the target does as “proof of concept” to advance the clinical study’s dose escalation. “The first patient dosed in Part A of the study achieved insulin independence at Day 270, with a HbA1c of 5.2%,” it says. “The second patient dosed in Part A has shown robust increases in fasting and stimulated C-peptide, and reductions in exogenous insulin requirements through Day 150… Per the study protocol, the Independent Data Monitoring Committee reviewed the totality of the safety and efficacy data from the first two patients dosed in Part A of the study and recommended advancement to Part B, where patients receive the full target dose of VX-880\. The first patient to receive the full target dose has achieved the Day 29 follow-up milestone.”

Vertex says VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including glucose-responsive insulin production. “VX-880 is delivered by an infusion into the hepatic portal vein and requires chronic immunosuppressive therapy to protect the islet cells from immune rejection,” it says.