Type 1 Diabetes Cell Therapy Trial Receives IRB Approval to Proceed
The trial will take place at the University of Miami Health System and will be carried out in collaboration with the Diabetes Research Institute.
An institutional review board (IRB) has given approval for Creative Medical Technology Holdings to proceed with the phase 1/2 CREATE-1 clinical trial (NCT05626712) for the evaluation of CELZ-201 (AlloStem), an investigational cell therapy based on perinatal tissue-derived cells (PRDC), in the treatment of newly diagnosed type 1 diabetes (T1D).1
CELZ-201 is intended to incorporate advantages of PRDC, including “self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion.” Creative Medical Technology Holdings previously received clearance of its investigational new drug (IND) application for CELZ-201 in November of last year.2 At the time, the company noted that the trial was expected to begin recruiting patients in the first quarter of 2023. The trial will take place at the University of Miami Health System and will be carried out in collaboration with the Diabetes Research Institute. Camillo Ricordi, MD, Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, and Professor of Biomedical Engineering, and Microbiology and Immunology at the University of Miami, will serve as the national principal investigator.
"I am excited to proceed with the CELZ-201 perinatal cell product in this study, as I believe that if successful it could result in a promising treatment for many patients with T1D," Ricordi said in a statement regarding the news.1
The open-label trial will aim to enroll 18 patients aged 18 to 35 years who have been diagnosed with T1D within 180 days of screening. Participants will be required to have a stimulated C-peptide peak level greater than 0.6 ng/mL and an estimated glomerular filtration rate greater than 80 ml/min/1.73m2. Patients with a BMI greater than 28 kg/m; HbA1c greater than 9%; systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg; a history of cardiac disease or any clinically significant abnormality identified on prior cardiac stress test, angiogram evaluation, or echocardiogram; eating disorders; liver disease, portal hypertension, or any coagulopathy or long-term anti-coagulant therapy excepting low-dose aspirin; uncontrolled thyroid disease; symptomatic cholecystolithiasis; acute or chronic pancreatitis; or currently symptomatic peptic ulcer disease will be excluded from participation. Additional exclusion criteria relate to patient health status, health history, laboratory values, concomitant treatments, and treatment history.
The study will randomly assign 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 will receive SOC alone. The trial’s primary end point is the number of participants who experience adverse events (AEs), assessed at 6 months. Secondary end points include 12 month and 24 month assessments of the number of participants who have experienced AEs, changes in glycosylated HbA1c, changes in insulin requirements, changes in islet autoantibody levels, changes in alloreactive antibody levels, and changes in fasting, peak stimulated, and area under the curve C-peptide during a 4-hour mixed-meal tolerance test. The trial’s estimated completion date is January 31, 2026.
"The purpose of IRB review and approval is to assure that appropriate steps are taken to protect the rights and welfare of patients participating as subjects in the research and is an important milestone in proceeding with a clinical trial,” Timothy Warbington, chief executive officer, Creative Medical Technology Holdings, added to the statement.1 “We are pleased with achieving IRB approval expeditiously and look forward to moving forward with our phase 1/2 clinical trial.”
