Creative Medical Technology Holdings has released one-year follow-up data from a pilot study evaluating its investigational allogeneic cell therapy, AlloStem (CELZ-201), in patients with late-stage type 2 diabetes (T2D). The study reported that AlloStem demonstrated an 80% efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c (HbA1c) levels, with no serious safety events observed.
The trial enrolled 20 participants with late-stage T2D, with 10 receiving AlloStem and the remaining 10 undergoing optimized medical therapy. After one year, patients in the AlloStem group showed a reduction in insulin dependency compared to the control group. Based on these findings, Creative Medical Technology has stated its intention to continue developing AlloStem for T2D and to explore potential applications in other conditions.
“AlloStem’s one-year data represents an important development in our efforts to advance diabetes treatment for patients who may not benefit from autologous therapies,” said Timothy Warbington, President and CEO of Creative Medical Technology.
AlloStem is also being evaluated in the ongoing CREATE-1 clinical trial for newly diagnosed type 1 diabetes (T1D). The trial, approved by an institutional review board (IRB) after FDA clearance of an investigational new drug (IND) application, is being conducted at the Diabetes Research Institute, University of Miami Miller School of Medicine. The primary objective is to assess adverse events at six months. Patients in the treatment group receive Allostem via intra-arterial infusion into the dorsal pancreatic artery along with standard-of-care treatment.
The findings from the AlloStem pilot study contribute to ongoing research in regenerative medicine for diabetes management.
