Pancreatic islet transplantation is an approach designed to restore the body’s ability to produce insulin by transplanting beta cells (insulin-producing cells) from a donor pancreas. I don't consider most of these to be cures, because they require taking immune suppression drugs for the rest of the person's life. For me, that is just trading one disease for another.
However, part of the eye (the anterior chamber) is what immunologists call an "immune-privileged" site — meaning the immune system is naturally less aggressive there than elsewhere in the body. This trial is testing transplanting beta cells into the eye, rather than into the abdomen. Instead of taking systemic anti-rejection drugs that affect the entire body, participants receive localized immune-suppressing treatment in the form of eye drops applied directly to the eye. Because the immune suppression is localized rather than systematic (whole body), the risks are far less. For me, that is a big advantage and means this might really be a cure.
The transplantation procedure is expected to take about twenty to thirty minutes.
The Study
This is an old study that I have not previously blogged on. It started in 2019, just before COVID and they hope to finish at the end of 2026 (but see below).
This is a small (2 person) Phase 1 trial where everyone gets the treatment. There is no control group. To be eligible, participants must be between 18 and 75 years old and have T1D or type 2 diabetes (with or without insulin dependence). Most importantly, they must be legally blind in at least one eye — meaning the transplant goes into an eye that has already lost most or all useful vision, so the participant's sight is not put at additional risk.
The trial's three primary endpoints are all assessed at 24 months after transplantation. The first two focus on safety, but the third is effectiveness related: C-peptide in the fluid of the transplanted eye and direct visualization of the islet graft using standard eye examination tools and imaging.
To learn more or inquire about participation, contact:
Midhat H. Abdulreda, Ph.D.
Diabetes Research Institute, University of Miami
Phone: 305-243-9871
Email: mabdulreda@miami.edu
Trial locations:
- Bascom Palmer Eye Institute, Miami, Florida, USA
- Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, USA
Discussion
The clinical trial registry claims they will finish collecting data from patients at the end of 2026 and publish results in 2027. However, that is obviously not correct, because they are still recruiting, and need to follow patients for 2 years. So obviously the clinical trial registry has not been updated. I don't know if they have stopped recruiting and the completion dates are correct or if they are still recruiting and the completion dates are wrong.
No matter what is published, however, this study only includes 2 people, so even if the results are very positive, several more studies will be required.
Because the transplantation is in the eye, doctors can observe the transplanted cells directly using imaging tools that are already widely used in by eye doctors. In theory, this could allow researchers to monitor graft health and immune reactions in ways that are not possible when islets are transplanted elsewhere.
The scientific foundation for this trial was laid over many years in baboons. Animal studies were published in 2011, 2019, and 2020, by the same researchers involved in this trial. These studies showed C-peptide creation, successful immune tolerance without whole body immune suppression, and general safety.
More Information
- ClinicalTrials.gov (US FDA registry): https://clinicaltrials.gov/study/NCT02846571
- Diabetes Research Institute — study page for participants: https://diabetesresearch.org/intraocular-islet-transplant/
- University of Miami Miller School of Medicine — announcement of the trial: https://news.med.miami.edu/miller-school-diabetes-trial-eye-pancreatic-islet-transplant
- CellR4 publication on intraocular islet transplantation: http://www.cellr4.org/article/2120
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official BreakthroughT1D or JDCA news, views, policies or opinions. I sometimes use generative AI ("chatbots") to generate draft blogs, parts of blogs, or drafter alternate wordings for these blogs. I always review every part of every published blog to ensure that it is saying what I want, in the tone that I want, truthfully, and accurately. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. I am obese and right on the border of T2D and therefore may be taking drugs for those conditions. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
