Clinical Trial

Disease: Type 1 Diabetes, T1D (NCT05565248)

Disease info:

Type 1 diabetes (T1D) is an autoimmune disease that results in destruction of the insulin-producing beta cells of the pancreas. The resulting insulin deficiency leads to rising blood glucose levels that over time can lead to a range of complications involving the heart, eyes, kidneys, nerves, gums and teeth.

T1D may debut at any age but it usually begins in childhood or early adulthood, and is fatal if untreated. The standard current treatment is regular blood glucose monitoring and subcutaneous administration of modified human insulin expressed in heterologous hosts, e.g., E. coli.

Approximately 1 out of every 300 individuals will develop type 1 diabetes by the age of 18 in the United States and Europe. The rate is much lower in Asia and South America with only 1 in 1 million new cases per year.
Official title:
An Open-Label, First-in-Human Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With Type 1 Diabetes Mellitus (T1D)

Study Director: Manasi Jaiman, MD, MPH - ViaCyte
Study Director: Sandeep Soni, MD - CRISPR Therapeutics


Canada, Alberta, University of Alberta

Recruiting: Edmonton, Alberta, Canada

Contact: Sara Qureshi   

Canada, British Columbia, University of British Columbia

Recruiting: Vancouver, British Columbia, Canada

Contact: Study Coordinator   

Contact: Clinical Trials+1 (877)

Study start:
Jan. 20, 2023
40 participants
Gene editing method:
Type of edit:
Disruption and insertion
Delivery method:
- Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D.

VCTX211 combination product (unit) compromises 2 components: (1) allogeneic pancreatic endoderm cells (PEC211) genetically modified using Cluster Regularly Interspaced Short Palindromic Repeats/ CRISPR-associated protein 9 (CRISPR-Cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain PEC211 cells.

Last updated: Jun. 5, 2023
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