Summary of Three Months of New Trials
This is a quick summary of all of the new clinical trials into type-1 that started between July 1st and October 1st, 2012. These are trials which were entered for the first time during these three months. I got this list from the FDA's clinical trial database, which is on line here:
www.clinicaltrials.com
37 New clinical trials in total
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14 Delivery / New Insulins / New Test Kits
06 Long Term Side Effects
03 Artificial Pancreas
03 CGM
01 AAT
01 Psychological
08 Other (1 of these was a Vitamin-D trial)
My only comment is that only one of these (the AAT one) might lead to a cure. That's not a lot.
What's Up with AAT (alpha-1 antitrypsin)?
The new AAT study reminded me that there are now a total of five AAT studies ongoing, and that's enough to have a summary of AAT research, so here it is.
I've blogged on AAT before, here:
http://cureresearch4type1diabetes.blogspot.com/search/label/AAT
and some background on AAT is here:
http://cureresearch4type1diabetes.blogspot.com/p/drugs-and-treatments-in-clinical-trials.html
Study Number Phase Size Sponsor Duration Completion Date
NCT01304537 I 24 Kamada 1 year November 2012
NCT01319331 I 15 Omni Bio 2 years September 2013
NCT01183468 II 16 NIAID 2 years November 2014
NCT01183455 II 66 NIAID 2 years November 2014
NCT01661192 II 24 Kamada 3 years December 2016
Initially, that looks pretty good. Unfortunately, one of these trials (the second one, by Omni Bio) released some early data, and this data was only slightly positive. The treatment showed no benefit to people with established type-1, and relatively small improvements to people who took it soon after diagnosis. No specific numbers were published, which I consider to be a bad sign. The first complete study (Kamada's) should be done very soon, and that should give us a much better "feel" for the level of success. By 2015 we should have results on four studies, which should be definitive.
Another Trial for Zhao's Cell Educator (if they raise money)
I've previously blogged on Zhao's work here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Zhao
It looks like researchers in New Zealand are raising money specifically to replicate Dr. Zhao's work.
Here is their description of what they want to do:
In the first trial we would infuse activated stem cells back into the patient and measure their ability to switch the behaviour of aggressive T lymphocytes to ‘peaceful’ T regulator cells. Trials like this are occurring internationally but without the activation step, and results are not yet clear. The second trial will be similar to the Chicago study [Zhao's trial, which was actually done in China]. The stem cells from each person will be used in the laboratory to ‘condition’ their white blood cells in the laboratory, before re-infusing the white blood cells.I don't usually put information about donating money in my blog posts, but I've gotten several requests for information on how to help fund Zhao. I don't know how an individual can do that effectively, but the researchers in New Zealand have these instructions:
If you would like to make a donation towards this cause, then the Spinal Cord Society NZ website www.scsnz.org.nz provides a means for you to do that. An email plus a donation will ensure that your contribution goes only towards the joint SCSNZ-Diabetes research work.Please remember: I know nothing about these guys or this organization. I am not endorsing them!
News: http://www.scsnz.org.nz/assets/Uploads/diabetes-winter-2012-focus-2.pdf
News: http://www.stuff.co.nz/national/health/7914909/Stem-cell-study-holds-diabetes-cure-promise
I want to especially thank Brian Braxton for the information and sources he provided, and everyone else (there were several) who pointed this news out to me.
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. My blog contains a more complete non-conflict of interest statement.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/
15 comments:
The two researchers are Dr Paul Turner and Dr Jim Faed - both highly respected. Jim Faed is a haemotologist at Otago Medical School. It is so exciting that they want to build on Zhao's study and I hope they manage to get the funds together asap. Sooner is definitely better!
Answering your question, Joshua, you can help Yong directly with the chance of a positive outcome, just go to http://www.tianhecell.com/Invest.html
You can help Yong directly, Joshua, even with the chance of a positive outcome, just go to http://www.tianhecell.com/Invest.html
Hi Joshua. Do you have any possibilty to verify information provided on the web page above?
Especially here: http://www.tianhecell.com/Page_14.htm
It looks like dr Zhao is giving paid on-line consultations,which to me is an obvious scam.
some news from Poland that I haven't found here. Altough it's all about honeymooners I think it is worth to mention in context of dr Zhao's work. http://www.ncbi.nlm.nih.gov/pubmed?term=Ilona%20Techmanska
The Page_14.htm referred to above is not available to me. I even looked in the wayback machine, and it has no record of that page ever existing, so I can not give you an opinion on what was there.
Joshua Levy
The work that was done in Poland, that Molinski linked to above: that sounds just like some research being done in California. The title of the California research is: T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
More info here:
http://www.clinicaltrials.gov/ct2/show/NCT01210664
I hope the researchers in Poland are talking to the researchers in California!
Joshua
And visa-versa: the researchers in California talking to the researchers in Poland.
there is "l" missing at the end of link I have given. If it's not gonna work either here is introduction to a registration form:
Please enter your information for your personal virtual consultation with Dr. Zhao. Feel free address any questions or concerns regarding your illness or about Stem Cell Educator Therapy. Dr.Zhao will provide you with information from his research and clinical expertise (in type 1 diabetes, type 2 diabetes, Alopecia Areata, Hashimoto's thyroiditis, Sjogren's syndrom, and other autoimmune diseases) that may bring about the treatment you need.
After submitting this Form, you will be directed to the next page to pay a consultation fee of $50 via PayPal. Dr. Zhao should get back to you within 24-48 hours after we receive your payment.
Łukasz, that's a complex question and I only have room for a simple answer, but here it is:
First, usually the FDA does not accept clinical trials if the patients have to pay a fee to enter the trial. That's not a USA law, it is an FDA rule. But if you want your trial to be considered for treatment approval, you can not charge people to enter the trial.
Second, it is normal for doctors in the USA to have clinical practice, that patients pay for, and also do research, that patients they don't pay for, and to refer from the practice to the trial.
So if the $50 fee is really for a professional consultation, then that is fine. But if it is really an entrance fee for the trial, then that is a problem.
You should get into the trial, because you meet the entrance requirements. If paying the $50 fee increases your chances of getting into the trial (or if not paying the fee lowers your chances), that is a problem.
However, as I said before, it is common to recruit patients from a paid practice into an unpaid trial.
Joshua
Lukasz, you do not need to pay in advance to be considered to participate in the trial. Just read the papers you will find at http://www.tianhecell.com/Publications.html and email to info@tianhecell.com
Gonzo,
I am familiar with dr. Zhao work. Mostly from what I have read here. I am realy impressed and I wish him best to finally achieve his goals.
I am skeptical because:
1.From what you wrote above I understand that even if I don’t have to pay in advance, participation in clinical trial is paid.
2.I am really suspicious about clinics spread out all over the word that are “specialized” in curing incurable diseases. I mean especially stem cell clinics.
3.Anyone can build an internet site, write some stories, attach scientific articles and then end up with statement “you want more? Pay me” -bvatec.com for example. And I don’t have any proof that it goes straight to dr. Zhao.
This is why I wanted to discuss it here to verify.
regards
SCSNZ is a lay organisation that funds a research laboratory at the University of Otago Centre for Innovation. The laboratory has been in operation since 2002. The main focus of the work of this laboratory is the use of bone marrow-derived mesenchymal stromal (stem) cells (MSCs) in regenerative medicine. Although SCSNZ has the long term aim of effective new treatments for spinal cord injury, they initiated contact with diabetes specialists and a leading immunologist in Dunedin because they recognised the enormous value that MSCs can potentially bring to treatment of autoimmune disease, type I diabetes.
Type I diabetes was chosen by the SCSNZ researchers because testing MSCs in this condition is likely to produce more useful information than studies on other autoimmune disorders. A trial in T1 D also will be easier to carry out because the large numbers of people affected by T1D will provide access to a well characterised group of affected people. However, one of the main reasons for choosing that T1D is that the target antigens attacked in this disease are better characterised than in most other autoimmune conditions. This will help the researchers identify specific changes in the autoimmune disease produced by MSCs. Success in treating T1 D is likely to lead quickly to trials in other autoimmune disorders that are less well characterised.
The researchers are being highly strategic and trying to get the greatest amount of information from the effort and dollars spent. They have aimed to broaden their funding base to include both the spinal cord injury community and the diabetes community as both have long term interests in seeing effective treatments developed. They are trying to be practical and to get to their long-term goal of treating spinal cord injury through working with other groups: Unity is Strength!
Contact SCSNZ by email at enquiries@scsnz.org.nz
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