CELZ-201 is a stem cell product, where the cells are isolated from the umbilical cord, Wharton’s jelly, placenta, amniotic membrane, and/or amniotic fluid and then treated in a proprietary way. (I have not found any information on how the cells are treated.) These cells are used to create a cell line, which is then used to treat everyone who gets the therapy. This is not the kind of stem cell treatment where a person gets their own cells. The cells are injected into the dorsal artery of the pancreas. No immune suppression is required.
The Study
This is a pilot study / phase-I clinical trail, called CREATE-1, which will enroll 18 people within 6 months of diagnosis, who are between 18 and 35 years old. 2/3s will get the treatment and 1/3 will be a control group. This study is open label / not blinded.
The people enrolled will get one dose of the stem cell product infused into an artery. They will then be followed for two years. The primary end point is adverse effects after 6 months, and the most important end point (for me) is a C-peptide measure after one year, which they track as a secondary endpoint.
They started recruiting in April 2023, and are expecting to finish the trial in January 2026. The company involved is Creative Medical Technology Holdings Inc, specifically their AlloStem program. The study is being run by the Diabetes Research Institute (DRI).Recruiting
Creative Medical Technology (480) 399-2822
clinicaltrials@creativemedicaltechnology.com
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Contact: Camillo Ricordi, MD 305-243-6913
Clinical Trial Record: https://www.clinicaltrials.gov/ct2/show/NCT05626712
Discussion
This research fits into a long line of research trying to cure T1D in a similar way. It is a classic "stem cell" cure. For it to work, the stem cells that they are implanting will need to integrate into the pancreas (to absorb food and oxygen and shed waste products), produce insulin, not be attacked by the body's regular immune system, and avoid being targeted by the immune system (the same immune reaction which triggered T1D originally).
Creative medical Technologies is a holding company that has several different technologies "in house". The CELZ-201 treatment comes from their AlloStem line. But another line of research they are working on is called ImmCelz, and they are currently testing two treatments from that line: CELZ-101 for brittle Type 1 Diabetes and CELZ-001 for Type 2 Diabetes. Both AlloStem and ImmCelz are cellular treatments (i.e. not chemical drugs, not specific proteins or peptides, but whole cells), and they both have CELZ numbers for identification. However, they come from different lines of research.
Their Type 2 Diabetes application (CELZ-001) recently had good results in a small trial:
Researchers released early clinical trial results on an innovative cell treatment for people with type 2 diabetes. After one year, 93% of those who received the treatment safely reduced their insulin doses by at least 50%.
You can read more about it at DiaTribe: https://diatribe.org/positive-results-new-type-2-diabetes-cell-therapy-trial
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