What Is Being Tested?
These researchers are taking someone's own blood, and then process it before putting it back into the person's body. I'm not sure the exact nature of this processing. The pilot study makes it sound similar to Dr. Zhao's work (exposing the patient's cells to stem cells). However, an interview in ASweetLife.com makes it sound like a filtering process. It may be both. The description in the FDA Clinical Trial record for their upcoming phase-I study talks about donors and "passaging" the cells, which might be a shorthand for the same process used in the pilot study. Whatever their process is, it focuses on three types of immune cell markers: CD34+, CD133+, and CD271+. The process is similar to Dr. Zhao's and also to the T-Rex study. This is not a classic transplant, because the patient is getting their own cells back, and immune suppression drugs are not used.
These researchers are taking someone's own blood, and then process it before putting it back into the person's body. I'm not sure the exact nature of this processing. The pilot study makes it sound similar to Dr. Zhao's work (exposing the patient's cells to stem cells). However, an interview in ASweetLife.com makes it sound like a filtering process. It may be both. The description in the FDA Clinical Trial record for their upcoming phase-I study talks about donors and "passaging" the cells, which might be a shorthand for the same process used in the pilot study. Whatever their process is, it focuses on three types of immune cell markers: CD34+, CD133+, and CD271+. The process is similar to Dr. Zhao's and also to the T-Rex study. This is not a classic transplant, because the patient is getting their own cells back, and immune suppression drugs are not used.
Results from Stem Cells of Arabia's Pilot Trial of Stem Cells
The only information I have is from an abstract. I think it is from a talk given at the 2015 International Cord Blood Symposium conference, and was published in the journal Transfusion (abstract only).
The patients' average age was 35 years old, but ranged from 13-52, but there was no information on their honeymoon status. The average A1c at start was 9.0, average Fasting Blood Sugar 350 (although I'm not sure what that means in a type-1 diabetic), C-peptide average was 0.06 (three people had 0.00 and one had 0.23.
Here is the complete results section of the abstract:
The only information I have is from an abstract. I think it is from a talk given at the 2015 International Cord Blood Symposium conference, and was published in the journal Transfusion (abstract only).
The patients' average age was 35 years old, but ranged from 13-52, but there was no information on their honeymoon status. The average A1c at start was 9.0, average Fasting Blood Sugar 350 (although I'm not sure what that means in a type-1 diabetic), C-peptide average was 0.06 (three people had 0.00 and one had 0.23.
Here is the complete results section of the abstract:
There were no complications over the follow up period (14-51 months). Three out of four patients completely stopped their insulin requirement at 6 months. All 4 patients showed significant improvements in Fasting Blood Sugar (average 145), C-peptide (average 1.01), and HbA1c (average 7.0), during 12 months post transplantation.Discussion
This is a study where only having the abstract really hurts. Obviously, these results look very good, but there are key details missing. If the reported C-peptide numbers are fasting, and measured in ng/ml, those are excellent, but if they are in response to eating, then they are not particularly strong. (The abstract does not say.) Having 3 out of 4 patients not using insulin at six months is great, but there is no information on how long each person did not need to use insulin. The results are great for established type-1 diabetes, but the abstract doesn't say how many people are established vs. honeymooners.
Based on those results, it is easy to see why this group is excited about doing a larger study. I'm excited too!
Based on those results, it is easy to see why this group is excited about doing a larger study. I'm excited too!
University of Jordan Starts a Phase 1 Trial of Stem Cells
This is the start of the study which was previously discussed on ASweetLIfe:
http://ift.tt/2q9eOk1
Now the study has officially started and there is a FDA Clinical Trial Record with the details of how the study will work.
This is a 20 person study, which will enroll adults (between 18 and 35) who have been diagnosed within 3 years, or are still generating C-peptide at a rate of 0.5 ng/ml or more. They expect to finish the study in July 2018. Some people will get a small dose of stem cells, while others get a larger dose. There is no control group. Patients will be followed for 36 weeks. The primary outcome is safety after 6 months. No effectiveness outcomes are mentioned.
Cell Therapy Center, Amman, Jordan, 11942
Contact: Abdalla Awidi, MD 0096265355000 ext 23960 abdalla.awidi@gmail.com
(I think this phone number would be +96265355000 ext 23960, where + means "whatever you need to do to get an international number".)
Web site: http://ift.tt/2pEmpna and http://ift.tt/2q9mEdB
Clinical trial registry: http://ift.tt/2pEykBG
Discussion
This is a quick study. Expecting to have results in less than 18 months is much faster than most clinical trials, and from my point of view, that's a good thing. On the other hand, there is no mention of reporting on the things that people with type-1 would care about. No A1c data, no C-peptide data, and no insulin usage data is listed in the secondary outcomes. Hopefully those things will be reported on, but most studies (even phase-I studies) list these as secondary outcomes.
This research is based on the same basic ideas which also led to Dr. Zhao's "Cell Educator" research, but the two approaches are not the same treatment. Dr. Al-Zoubi's group is taking stem cells from a person with type-1 diabetes, treating them, and then injecting them back into that patient. Dr. Zhao is taking stem cells from third parties, and then exposing people's immune cells to proteins made by those cells, but the stem cells themselves are never injected into the patient. But both approaches are trying to harness proteins created by stem cells.
Joshua Levy
http://ift.tt/2fs7dVR;
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.
This is the start of the study which was previously discussed on ASweetLIfe:
http://ift.tt/2q9eOk1
Now the study has officially started and there is a FDA Clinical Trial Record with the details of how the study will work.
This is a 20 person study, which will enroll adults (between 18 and 35) who have been diagnosed within 3 years, or are still generating C-peptide at a rate of 0.5 ng/ml or more. They expect to finish the study in July 2018. Some people will get a small dose of stem cells, while others get a larger dose. There is no control group. Patients will be followed for 36 weeks. The primary outcome is safety after 6 months. No effectiveness outcomes are mentioned.
Cell Therapy Center, Amman, Jordan, 11942
Contact: Abdalla Awidi, MD 0096265355000 ext 23960 abdalla.awidi@gmail.com
(I think this phone number would be +96265355000 ext 23960, where + means "whatever you need to do to get an international number".)
Web site: http://ift.tt/2pEmpna and http://ift.tt/2q9mEdB
Clinical trial registry: http://ift.tt/2pEykBG
Discussion
This is a quick study. Expecting to have results in less than 18 months is much faster than most clinical trials, and from my point of view, that's a good thing. On the other hand, there is no mention of reporting on the things that people with type-1 would care about. No A1c data, no C-peptide data, and no insulin usage data is listed in the secondary outcomes. Hopefully those things will be reported on, but most studies (even phase-I studies) list these as secondary outcomes.
This research is based on the same basic ideas which also led to Dr. Zhao's "Cell Educator" research, but the two approaches are not the same treatment. Dr. Al-Zoubi's group is taking stem cells from a person with type-1 diabetes, treating them, and then injecting them back into that patient. Dr. Zhao is taking stem cells from third parties, and then exposing people's immune cells to proteins made by those cells, but the stem cells themselves are never injected into the patient. But both approaches are trying to harness proteins created by stem cells.
Joshua Levy
http://ift.tt/2fs7dVR;
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.
via Cure Research
No comments:
Post a Comment