T1D Human Trials Happening Right Now

As of July 2024, there are 634 type 1 diabetes (T1D) clinical trials this year. Here are a few of many studies currently registered with the U.S. Food and Drug Administration (FDA) that generate potential hope toward a cure.

Whether through cell supply solutions (cell transplantation and cell generation), smart insulin, or cell protection solutions like encapsulation, gene editing or immune system modification—the pathway to a cure utilizes all of these studies and crossover trials to bring about the needed treatment and eventual remedy for T1D.

Here are the top 8 clinical trials to cure type 1 diabetes, generating a buzz in the scientific world.

The OPERA Study

Abu Dhabi Stem Cells Center (ADSCC), a renowned healthcare institution in Abu Dhabi, United Arab Emirates (UAE), is conducting the OPERA study.

The OPERA study uses extracorporeal photopheresis (ECP), a non-surgical blood-filtering action, as a potential treatment for type 1 diabetes. The ECP procedure involves drawing blood, separating white blood cells, combining them with a photoactive drug, and reinfusing them into the patient. 

To be eligible, T1D patients must be within the first three years of onset and must meet specific blood criteria. Additional information about the OPERA Study is available on ClinicalTrials.gov (NCT05413005) or through the provided contact details on the website.

PlpepTolDC Immunotherapy Study at City of Hope

This breakthrough trial (PlpepToIDC) at the City of Hope Medical Center in Duarte, CA, uses immune system medication and cell regeneration. This immunotherapy uses a patient’s immune cells and a beta cell protein to teach the immune system to stop attacking the insulin-producing beta cells. 

Sponsored by the Wanek Family Project for Type 1 Diabetes, the Phase 1 trial is open to people between 18 and 45 years old, diagnosed with T1D within the last four years.

CRISPR Therapeutics  VCTX-211™ (aka CTX-211)

The VCTX-211 clinical trial at the University of Alberta, Canada, is a gene-edited, stem cell-derived investigational therapy incorporating encapsulation and additional gene edits to enhance cell fitness. The durable, removable device is designed to protect and maintain the PEC211 cells.

Umbilical T Cells Plus Liraglutide

The Umbilical T Cells Plus Liraglutide clinical trial study at the Second Xiangya Hospital in Hunan, China, uses cell regeneration and immune system modification. Regulatory T cells pulled from umbilical cord blood ex-vivo have shown the capacity to control immune responses in autoimmune diseases like T1D. 

Combined with glucagon-like peptide (GLP-1) drugs, the two provide a hopeful therapeutic way to treat autoimmune diseases. Eligibility criteria involve T1D patients within three years of diagnosis over 18 years old.

Faustman Lab Repeat BCG Vaccinations for the Treatment of T1D

Researchers at the Massachusetts General Hospital in Boston, MA, are testing immune system medication and cell regeneration. The clinical trial incorporates the BCG vaccine (used to treat T.B.), which is believed to balance the autoimmune attack while regenerating insulin-producing cells.

Throne Biotechnologies’ Stem Cell Educator 

The Hackensack University Medical Center in Hackensack, NJ, is hosting a clinical trial with cell regeneration therapy and immune system modifications. In April 2024, Throne received FDA approval for regenerative medicine advanced therapy (RMAT) in conjunction with stem cell educator (SCE) therapy to treat T1D. 

Here, the T cells pass through an education device coated with umbilical cord-derived stem cells before returning to the body, which is hopefully trained to stop the autoimmune attack. Clinical trials in the U.S., China and Spain have shown that SCE therapy improves metabolic control and regenerates beta cells in T1D patients, even those who’ve had T1D for many years.  

VERTEX’s VX-264 International Trials

Vertex’s investigational approach encapsulates cells in a protective device surgically implanted in the body. The VX-264 trial does not require immunosuppressive therapy as the device protects cells from the immune system’s attack.

VX-264 is one of the most anticipated research trials for individuals with type 1 diabetes. These implanted islet cells have the potential to control blood sugar levels by protecting the cells from the immune system’s attack.

Akademiska Sjukhuset’s UP421S

Clinical trials are underway at the Uppsala University Hospital in Uppsala, Sweden, using cell transplantation and gene editing. Here, the donor cells are genetically modified using Sana Biotechnology’s hypo-immune platform to escape an immune system attack and evade the need for immunosuppressant drugs. The cells are then transplanted into the participants’ forearm muscles.

A Growing Epidemic

Diabetes mellitus (D.M.) currently affects around 463 million individuals worldwide, and that number is expected to rise to 700 million by 2045. 

While a 2022 study by the Centers for Disease Control and Prevention (CDC) cites that the number of young people with T1D in the United States could increase by up to 65% in the next 40 years, while type 2 may increase by nearly 700% by 2060.

With numbers expected to rise, a cure is needed now more than ever. The most excellent chance for a cure will be found in combined influences and collaborative efforts within many funded projects.