Investigational Cell Therapy Cuts Insulin Dependency in Late-Stage Type 2 Diabetes

Creative Medical Technology announced positive one-year efficacy and safety results from the CELZ-201 (AlloStem™) pilot study examining the platform for the treatment of type 2 diabetes (T2D).¹

The investigational cell therapy demonstrated an 80% overall efficacy rate in reducing insulin dependency and stabilizing HbA_1c levels, with no serious adverse effects reported, the company announced in a February 11, 2025, press release.¹

"The positive one-year data from the study represents a significant milestone in our mission to revolutionize diabetes treatment and help a wide variety of patients who potentially may not benefit from autologous therapies,” Timothy Warbington, president, and chief executive officer of Creative Medical Technology, said in the statement.¹

CELZ-201 is an off-the-shelf, allogeneic, ready-to-use universal and proprietary cell therapy designed to modulate immune and inflammatory responses, which are implicated in the progression of T2D.¹

In the US, T2D accounts for more than 90% of all diabetes cases and is defined by a diminished response to insulin, categorized as insulin resistance. Most common in adults aged 45 years and older, rates of T2D are rising in younger individuals given the subsequent rise of obesity, physical inactivity, and energy-dense diets. Initially managed through diet, exercise, and oral medications, many patients require insulin therapy down the line as the disease progresses.²

The study enrolled 20 patients with late-stage T2D, with 10 receiving CELZ-201 and 10 undergoing optimized medical therapy. Safety analysis reported no serious adverse effects linked to CELZ-201.¹

According to Creative Medical Technology, these data validated the safety and efficacy of CELZ-201 using the same infusion procedure as the company’s ongoing US FDA-cleared clinical trial in type 1 diabetes (T1D). In addition, they noted the lack of safety signals supported the potential of CELZ-201 as a breakthrough treatment for late-stage T2D.¹

In the release, the company also announced plans to continue to advance the development of CELZ-201 for late-stage T2D and explore further potential applications to expand their clinical pipeline.¹

“With a diversified portfolio that includes CELZ-201 for early-stage T1D, CELZ-101 for brittle T1D, and CELZ-201 for late-stage T2D, we are committed to delivering innovative solutions that transform patient care,” Warbington added.¹

References:

1. Creative Medical Technology Holdings, Inc. Creative Medical Technology reports positive one-year results for allostem^TM type 2 diabetes program. GlobeNewswire News Room. February 11, 2025. Accessed February 11, 2025. https://www.globenewswire.com/news-release/2025/02/11/3024280/0/en/Creative-Medical-Technology-Reports-Positive-One-Year-Results-for-AlloStem-Type-2-Diabetes-Program.html

2. Type 2 diabetes. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/diabetes/about/about-type-2-diabetes.html. Updated May 15, 2024. Accessed February 11, 2025.