CELZ-201 Cuts Insulin Dependency at 1 Year in Patients with Type 2 Diabetes

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

Announced on February 11, 2025, CELZ-201, an off-the-shelf, ready-to-use universal, and proprietary allogeneic cell line, demonstrated efficacy in reducing insulin dependency and stabilizing hemoglobin A1c (HbA1c) in patients with T2D.

“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,” said Timothy Warbington, president, and chief executive officer of Creative Medical Technology, in a statement.

Nearly 415 million adults worldwide are affected by diabetes, with the number expected to increase by another 200 million in the coming decades. 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, 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

This study included 20 patients, with half (n = 10) receiving CELZ-201 and the other half (n = 10) receiving optimized medical therapy. Upon analysis, CELZ-201 achieved an 80% overall efficacy rate in reducing insulin dependency and stabilizing HbA1c levels. 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 Food and Drug Administration (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.

“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 allostemTM 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. Goyal R, Singhal M, Jialal I. Type 2 Diabetes. [Updated 2023 Jun 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513253/