Creative Medical Technology Holdings receives FDA clearance and IRB approval for phase 1/2 trial of T1D cell therapy – February 8, 2023

The University of Miami’s Diabetes Research Institute will conduct the company-sponsored trial; patient recruitment is expected to begin in 1Q23

Arizona-based biotechnology company, Creative Medical Technology Holdings, announced today that it has received approval from the Western Institutional Review Board (WIRB) to proceed with its phase 1/2 trial for treating new onset type 1 diabetes (T1D) with its cell therapy program, CELZ-201. In November 2022, the company received FDA clearance of its Investigational New Drug (IND) application for this program. 

The trial, which will evaluate the safety and efficacy of CELZ-201 as a treatment for recent onset T1D, is expected to initiate recruitment in 1Q23, with an estimated enrollment of 18 participants, and is slated to complete in January 2026. The primary outcome measure will be the number of participants with adverse events across six months, and secondary outcome measures include A1c, C-peptide, and exogenous insulin levels across 12 months. The company-sponsored trial will be conducted at the University of Miami Health System in conjunction with the Diabetes Research Institute (DRI) with Camillo Ricordi, M.D. serving as the national principal investigator.

The platform: “First novel allogenic cellular therapy in the dorsal artery of the pancreas”

According to an announcement on October 2022, the company has developed an allogenic cell line called AlloStem™, which, based on prior press releases, consists of Perinatal Tissue Derived Cells (PTDC), or cells isolated from umbilical cord, placenta, amniotic membrane, and amniotic fluid. The company highlights that PTDCs have multiple benefits including reduced toxicity, self-renewal ability, low antigenicity, and do not require the patient to take immunosuppression. Interestingly, today’s press release notes that the therapy would be administered in the dorsal artery of the pancreas, distinct from Vertex’s VX-880 cells which are delivered by an infusion into the hepatic portal vein. We are eager to continue learning about the specifics of how this technology works, especially compared with Vertex’s VX-880 program, and we were pleased to gain more information, featured below, from Creative Medical Technology Holdings.

Close Concerns’ Questions and Answers from Creative Medical Technology Holdings

  1. What did preclinical studies demonstrate regarding the potential efficacy of CELZ-201? The committee submitted invitro, pre-clinical, and clinical supporting data to the FDA in order to receive clearance from the FDA. 
  2. How might the platform compare to Vertex’s VX-880 cells? What significance does the infusion location of each platform hold? The goal of CELZ-201 is to rescue the Islet Cells in the pancreas where as VX-880 has a goal of providing new Islet Cells.
  3. Does the company plan to research avenues that would not require immunosuppression? CELZ-201 does not require the patient to take any immunosuppression.


--by Mahima Chillakanti, April Hopcroft, and Kelly Close