Creative Medical Technology’s Cell Therapy AlloStem Reduces Insulin Dependency in Late-Stage Type 2 Diabetes
The company stated that at 1 year posttreatment AlloStem showed an 80% overall efficacy rate in decreasing insulin dependency.
Creative Medical Technology’s AlloStem (also known as CELZ-201), an investigational universal and proprietary allogenic cell line, has demonstrated the ability to reduce insulin dependency among patients with type 2 diabetes (T2D) treated in a pilot study.1
The study enrolled 20 participants with late-stage T2D in total, with 10 being assigned for treatment with AlloStem and the other patients receiving optimized medical therapy. Creative Medical Technology stated that at 1 year posttreatment AlloStem showed an 80% overall efficacy rate in decreasing insulin dependency and stabilizing levels of hemoglobin A1c. In addition, the company pointed out that there were no serious safety events observed. In light of these findings, Creative Medical Technology noted that it intends to continue moving forward with development of AlloStem in T2D and to explore its potential use in other indications.
"The positive 1-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, the president and CEO of Creative Medical Technology, said in a statement.1 "With a diversified portfolio that includes CELZ-201 for early-stage T1D, CELZ-101 for brittle type 1 diabetes (T1D), and CELZ-201 for late-stage T2D, we are committed to delivering innovative solutions that transform patient care."
AlloStem is currently being evaluated in the phase 1/2a CREATE-1 clinical trial (NCT05626712) for the treatment of patients with newly diagnosed T1D. Creative Medical Technology received approval from an institutional review board (IRB) to proceed with the trial in February 2023, following clearance of an investigational new drug (IND) application from the FDA in November 2022.2,3 CREATE-1 is taking place at Diabetes Research Institute, University of Miami Miller School of Medicine, in Miami, FL.
"This is a milestone event for Creative Medical Technology Holdings as it marks the company's first IND clearance from the FDA," Warbington said in a November 2022 statement.3 "We are excited to commence this trial under the guidance of one of the world's most respected diabetes clinical researchers and at a renowned research institute."
CREATE-1 randomly assigns participants to either the treatment arm, in which they will receive CELZ-201 at a dose of 1x106 cells/kg by intra-arterial infusion into the dorsal pancreatic artery along with standard of care (SOC) treatment, or the placebo comparator arm, in which patients receive SOC alone.2 The trial’s primary end point is the number of participants who experience adverse events (AEs), assessed at 6 months. AlloStem, which is based on perinatal tissue-derived cells (PRDC), is intended to incorporate advantages of PRDC, including “self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion.”2
Notably, in October 2023, Creative Medical Technology also received approval from an IRB for the phase 1/2a ADAPT clinical trial (NCT06053242), which is evaluating for CELZ-201-DDT, an StemSpine procedure using AlloStem, for the treatment of chronic lower back pain caused by degenerative disc disease.4 The randomized, placebo-controlled trial is expected to enroll 30 patients in total.
"We are pleased to announce the expeditious receipt of this vital next step in commencing the clinical trial for CELZ-201-DDT," Warbington said in an October 2023 statement.4 "Studies show that 8% of all adults in the United States, approximately 16 million people, experience chronic lower back pain. The economic impact is also significant, as a report from the National Library of Medicine estimates that $200 billion is spent annually on the management of back pain. In addition to limiting their daily activities and negatively impacting their quality of life, many of those suffering rely on opioids as the standard of care which carry their own side effects, not the least of which is addiction. We are hopeful that the outcome of this clinical trial will validate the efficacy, safety, and endurance of CELZ-201-DDT as a nonsurgical treatment option for chronic lower back pain."
