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# FDA Lifts Vertex Stem Cell Therapy Clinical Hold
- URL: https://www.fdaweb.com/fda-lifts-vertex-stem-cell-therapy-clinical-hold/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152232

FDA has told Vertex Pharmaceuticals it can proceed with studies for its diabetes stem cell therapy that was placed on a clinical hold in May. The company [says](https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-has-lifted-clinical-hold-vx-880-phase-12?ref=fdaweb.com) the agency had expressed concerns about a lack of information ahead of the dose-escalation portion of the study.

Known as VX-880, the therapy is designed to replace insulin-producing cells that type 1 diabetes patients lose with lab-grown insulin-producing cells.

Vertex says researchers plan to test the drug in five patients sequentially at the high dose level before moving to a concurrent dose cohort using the high dose. So far, the company says, it has administered the high dose to one patient and the low dose to two patients. Vertex says it intends to enroll 17 patients across all three parts of the study.