The company Encellin has started a Phase-I clinical trial to test ENC-201-CED an encapsulated beta cell product.
Encapsulated Beta Cells In General
Encapsulated beta cells are implanted devices. The encapsulation allows blood sugar in, and insulin out, but does not allow the body's immune system to attack the beta cells. It also allows nutrients in and waste products out. This allows the beta cells to naturally grow and to react to the body's sugar by generating insulin which goes into the body's blood system. Meanwhile, the body's autoimmune attack cannot target these beta cells, and you don't need to take any immunosuppressive drugs (as you would for a normal beta cell transplantation). The cells inside the encapsulation can come from different sources, depending on the company creating the product.
Encapsulated beta cells seem like a straight forward cure for type-1 diabetes, but companies have been working on them since the 1990s, without creating a cure. There appear to be several difficult problems to solve, especially getting oxygen to the new cells. Bottom line is this: while encapsulated beta cells sound like a "just needs engineering" cure for type-1 diabetes, decades of work has not led to a cure yet, so it is obviously harder than it looks.
I have blogged at least 10 times over the last 15+ years on different encapsulated beta cell approaches:
This Study
This study will recruit 10 people between 18 and 70 years old. Everyone will get the treatment. There is no control group. Everyone will be followed for about 4 months. This is strictly a safety/tolerability test. They are measuring adverse effects and how well the implant takes. They are not measuring effectiveness. Even in the secondary outcome measures there are no tests for A1c, Blood glucose, C-Peptide, or time in range.
The study started in March 2024 and they hope to finish in December 2025 and publish by July 2026.
Other than that, their clinical trial registry is very sparse, and I cannot find any information on the trial on the web site of the hospital which is actually running it. Therefore, I don't know the exact requirements to participate in the study, how many operations are required, what sort of immune suppression is being used (if any), or how man encapsulated beta cells (or devices) will be implanted.
Contact Information:
Study Contact: Phone: +1-650-434-0987 Email: info@encellin.com
Study Contact Backup: resCON Research Email: info@resconresearch.ca
They are recruiting at one site:
McGill University Health Centre Montréal, Quebec, Canada, H4A 3J1
Contact: Lin Jawhar
Principal Investigator: Steve Paraskevas, MD
Clinical Trial: https://www.clinicaltrials.gov/study/NCT06408311
Discussion
I usually don't comment on company funding because I have found that it doesn't matter who funds research. Sometimes big name companies fund failures and people I've never heard of fund successful research. However, I will say that Encellin is mostly funded by Khosla Ventures, which is a big name in Silicon Valley venture capital. Also, Encellin was incubated by Y-Combinator, which is a big name "factory" of Silicon Valley start ups. These guys would be Silicon Valley royalty, if Silicon Valley had royalty.
Company's Web Site: https://www.encellin.com/
History
About 7 years ago, there was a lot of excitement about research done at Tejal Desai's lab at UCSF. Several people asked me about it and at least one person lobbied for me to write a blog on it. There was widespread hope that this research would lead to a cure in a few years. There was widespread belief that it would lead to clinical trials sooner than that.
I didn't blog on it because my policy is to wait until recruiting has started on a clinical trial (a test done on people). Seven years ago, all we had was very optimistic press releases. But now, finally, this clinical trial is the follow on to Tejal Desai's work all those years ago. They have started a clinical trial on this technology and so I'm blogging on it.
Remember this when you are frustrated because some research that you heard very positive things about never seemed to go anywhere. First, a lot of very positive sounding research never does go anywhere. That is the normal nature of research. Second, even when it does, it takes many years. The successful out come still takes many years.
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 JDRF or JDCA news, views, policies or opinions. My kid has type-1 diabetes and has participated 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!
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