This clinical trial is studying people who were part of ViaCyte's clinical trial of VC-01™, an encapsulated beta cell cure. Once the device is removed at the end of the study, the patients can enroll in this follow on study which tracks them for three additional years, looking for adverse effects.
ViaCyte is a commercial company testing an encapsulated beta cell cure. You can read my previous blogging about them here: http://cureresearch4type1diabetes.blogspot.com/search/label/ViaCyte
They are in the middle of a large Phase-I study, which could finish as early as 2020.
Clinical record: https://clinicaltrials.gov/ct2/show/NCT02939118
I'm hopeful that this means that one person has finished the ViaCyte protocol, which is motivating them to start this follow on. The other option is that they are just planning ahead. Since there is no control group, the interim data could be published, if ViaCyte wanted.
Two Phase-I Studies Start with Umbilical Cord Treg Cells
These two studies have a lot in common, so I'm going to discuss them together: first, their similarities, then their differences. Here are the similarities:
- They are both run by the same researcher (Dr. Zhiguang Zhou) at the same hospital (Second Xiangya Hospital of Central South University).
- They recruit at the same place: Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, Changsha, Hunan, China, 410011
Contact: Zhiguang Zhou, MD/PhD 86-731-85292154 email@example.com
- They have already started recruiting 40 people, and expect to finish in 2019.
- These trials are open to people who have been diagnosed within 3 years and are between 6 and 60 years old.
- Each has a primary end point which is safety related, and secondary endpoints which are effectiveness related and include C-peptide, A1c, insulin usage, etc.
- Both studies will work with stem cells which have been harvested from umbilical blood, separated into components, and had the T-reg cells "grown out" for two weeks. These enriched T-reg cells will be infused into patients. T-reg cells are regulatory cells which are part of the immune system, and work by controlling other immune cells so that those other cells don't attack beta cells.
The first study is Safety Study and Therapeutic Effects of Umbilical Cord Blood Treg on Autoimmune Diabetes: This study will have two groups, one will get the treatment, and one will be a control group and will not get the treatment.
Clinical trial registry: https://clinicaltrials.gov/ct2/show/NCT02932826
The second study is Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes: This study has four groups. One will get the treatment and also Liraglutide, another just the treatment, a third just Liraglutide, and a fourth will be a control group. Liraglutide (sold as Victoza) is similar to exenatide (Byetta), which is a common type-2 medication, but is also sometimes used on type-1. Victoza is a weekly injection.
Clinical trial registry: https://clinicaltrials.gov/ct2/show/NCT03011021
The researchers are not clear on why they are using Liraglutide, but site its "various benefits for beta cells". They expect it will increase the effectiveness of the new T-regs, possibly by encouraging beta cell growth.
JDCA's Update on Dr. Faustman's Research
An update on Dr. Faustman's BCG research by the JDCA (Juvenile Diabetes Cure Alliance) is here:
My key takeaway points are:
* The Phase-II trial should finish in 2023.
* They have enrolled 125 out of the 150 they need.
* An 8 year follow up from their Phase-I trial should be published by the end of 2017.
(Remember, I am a fellow of the JDCA and we regularly discuss various research programs, including this one.)
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.