Thursday, August 19, 2010

Eight New Stem Cell Clinical Trials For Type-1 Diabetes

I hate putting out half-digested information, but I'm convinced that I will never have time to fully digest all of these studies, so I'm putting out what I have, on the basis that something is better than nothing.

This is a list of eight studies, which are pretty similar.  They all involve using stem cells to treat or cure type-1 diabetes.  Some of these studies use adult stem cells, others embryonic, and others cord, although I think the most common is the patient's own bone marrow stem cells.

I consider stem cells to be one possible way to regenerate beta cells.  My opinion of beta cell regeneration in general, is that it is not going to cure type-1 diabetes by itself (because the autoimmune attack will kill the new beta cells same as the old ones) but that it might be an important part of the cure.  It's importance depends on how fast beta cells regrow after the autoimmune attack is stopped.  If they grow back quickly, then no form of beta regeneration will be needed, but if they grow back slowly or not at all, then some form of beta regeneration will be needed.  Stem cells are one form of beta cell regeneration, but there are others.  Exsulin and human growth hormone have been tested in people, and CureDM's drug in animals, and there are many more.

The good news here, is that there is a lot going on with stem cells, so if we do end up needing new beta cells to cure type-1 diabetes, here are 8 or more reasons why we are likely to have them.  And that is not even counting all the non-stem cell technologies out there.  But (in my opinion) the "gating factor" (what we in the software industry call the "critical path") to curing type-1 on this path is stopping the autoimmune response, not regenerating the beta cells.

As you read these, you will notice that some of them have end dates in the past, but are still active today.  Others have start dates in the past, but have not actually started recruiting patients.  These are signs that the researchers have not updated the clinical trial records, and need to.  This is quite common.  "Primary Completion" is when they finish collecting the data from the patients.

Uppsala University Hospital Stem Cell phase-I Trial
Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011
Clinical Trial:

Armed Police General Hospital
Stem Cell Therapy for Type 1 Diabetes Mellitus
Cellonis Biotechnology Co. Ltd.
Estimated Enrollment: 24
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011

Clinical Trial:

Hospital Universitario Dr. Jose E. Gonzalez
Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus
Estimated Enrollment: 15
Study Start Date: May 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010
Clinical Trial:

Shanghai Jiao Tong University School of Medicine 
Autologous Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes
Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013
Clinical Trial:

Veterens Memorial Medical Centre
Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes
Adistem Ltd
Estimated Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009

Clinical Trial:

Shandong University
Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

Estimated Enrollment: 200
Study Start Date: March 2006
Estimated Study Completion Date: March 2014
Clinical Trial:

Technische Universität München
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
23 patients, but no start or end dates provided
Clinical Trial:

University of Moron
Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes
Stematix, Inc
Estimated Enrollment: 34
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2011
Clinical Trial:

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.


Fernando said...

Hey I have trying to classify T1D research to either cure T1D or help pacients control with higher and higher degress of efficiency. So this is what I have:

- Genetics inheritance
- Gen activation (environment)

To reverse:
- Stem Cells
- Implant of pancreas islet cells
- Imunosuppressor medicine
- Gene therapy

To control:
- Insulination treatment
- Oral medicine
- Inhaler medicine
- Insuline pump
- Insuline pump linked to glucose monitoring
- Nutritional plan
- Exercises

Could you help me futher elaborate this list, extending it?

Thank you.

Joshua Levy said...

In terms of "implant of pancreas islet cells", you could divide it up this way:
* Encapsulated cells
* Cells protected by Steroli cells
* Unprotected transplants (which require anti-rejection drugs, so I don't think they are a cure, but many do)
Under "immunosuppressor" medicine, I would divide that into two sections:
* Immune suppression (the anti-CD3 drugs, for example)
* Immune retraining (Diamyd, ATG, as examples)
In the control section, you might want to add a list for "Self dosing insulin (examples: SmartInsulin and SIA-II)
Finally, there is a recent interest in anti-inflammatories as a possible cure or treatment. Several drugs are in early clinical trials based on that theory.

Joshua Levy

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