Dakota15
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Bateman Horne Center in Salt Lake City, Utah
Cortene Peptide for MECFS? "Curative"?!
- Thread starter Ema
- Start date
shannah
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From the Cortene site:
Trial Specifics
Protocol: The trial design involves 18 patients, subjected to 2 exercise stresses (on a stationary bicycle), each followed by a 4-week recovery period, and separated by treatment (2x 3-hour infusions of the sterile drug solution, at 1 of 3 dose-levels—low, intermediate or high).
Endpoints: The study will compare pre- and post-treatment differences, in exercise performance and function during recovery, using a combination of objective and subjective endpoints. Objectively, we will measure exercise performance (via blood gases, work, time to ventilatory threshold, etc), and function during recovery (via continuous Fitbit monitoring providing data on activity, sleep, heart rate, etc, and daily online cognitive tests). Subjectively, we will measure daily symptom scores (and narratives on unusual activity and effects).
Progress: The Clinical Site (BHC) has identified several good candidates for treatment, and an initial 5-6 patients are potentially ready to start the trial. BHC is also recruiting other patients for a non-interventional trial, and many of these patients will be eligible for our trial.
In sum, if all goes well, we hope to start the trial at the beginning of July, have the first patient exit by early October and ideally, complete the low dose-level by end of October.
https://cortene.wordpress.com/2018/06/
Trial Specifics
Protocol: The trial design involves 18 patients, subjected to 2 exercise stresses (on a stationary bicycle), each followed by a 4-week recovery period, and separated by treatment (2x 3-hour infusions of the sterile drug solution, at 1 of 3 dose-levels—low, intermediate or high).
Endpoints: The study will compare pre- and post-treatment differences, in exercise performance and function during recovery, using a combination of objective and subjective endpoints. Objectively, we will measure exercise performance (via blood gases, work, time to ventilatory threshold, etc), and function during recovery (via continuous Fitbit monitoring providing data on activity, sleep, heart rate, etc, and daily online cognitive tests). Subjectively, we will measure daily symptom scores (and narratives on unusual activity and effects).
Progress: The Clinical Site (BHC) has identified several good candidates for treatment, and an initial 5-6 patients are potentially ready to start the trial. BHC is also recruiting other patients for a non-interventional trial, and many of these patients will be eligible for our trial.
In sum, if all goes well, we hope to start the trial at the beginning of July, have the first patient exit by early October and ideally, complete the low dose-level by end of October.
https://cortene.wordpress.com/2018/06/
wigglethemouse
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Cort quoted the following on July 8th in answer to a question in a recent blog on Health Rising.
https://www.healthrising.org/blog/2...me-cfs-research-center-fulfills-crucial-need/
FYI - the comment covers the planned Klimas trial in addition to the Bateman Cortene trials. Klimas mentioned in a Montreal Q&A video that she was hoping to start small trial in ME women in October and men by end of year using treatment based on her computer models and GWI experience.
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This is all dragging on; I know rationally what research and the academy is like, but for the sick it is just very difficult.
wigglethemouse
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Thanks Wigglethemouse,
I think I read today or yesterday that the trial will NOT begin of July. Was it on Cort's site? I can't recall. And I don't know the reason.
Dakota15
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@perrier I don't know if we (the public) are going to be privy to these details for why the delay...I'd love to be proven wrong though. Just don't want to get your hopes up
I'm very dejected these days because due to a lack of money and researchers young people are suffering excruciatingly, losing their best years. I was hanging on to the Rituximab trials, but that did not work out.
Thanks Dakota.
Dakota15
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@perrier I know all of us have a high urgency level for research/trials and rightly so, but I do believe there is a lot of hope to hang on to. Ron Davis's recent NIH grant with Mark Davis and T-Cell Activation, this Cortene trial that will eventually take place, Robert Phair's ongoing metabolic trap findings and research to name a few.
I just saw this article today too that came out yesterday with Dr. Ian Lipkin....I think this shows how much headway has recently been made.
"A study led by researchers at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health has identified a constellation of metabolites related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Combining this data with data from an earlier microbiome study, the researchers now report they can predict whether or not someone has the disorder with a confidence of 84 percent."
https://www.sciencedaily.com/releases/2018/07/180709120146.htm
All in all, I know it sounds like lip service but try to find hope in all of this.
I just saw this article today too that came out yesterday with Dr. Ian Lipkin....I think this shows how much headway has recently been made.
"A study led by researchers at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health has identified a constellation of metabolites related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Combining this data with data from an earlier microbiome study, the researchers now report they can predict whether or not someone has the disorder with a confidence of 84 percent."
https://www.sciencedaily.com/releases/2018/07/180709120146.htm
All in all, I know it sounds like lip service but try to find hope in all of this.
Thank you for your kindness Dakota (always loved that name-D_A_K_O_T_A)
The info is really moving, and that's great but there is nothing and no one as far as I know working on how to get rid of flu feeling, or malaise. But I'll try to be OK, it's just waiting decades isn't washing
Mary
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Cort posted today that the trial has received the go-ahead from the FDA and IRB and will commence "shortly" (no exact date, unfortunately!) https://www.healthrising.org/blog/2...ic-fatigue-syndrome-me-cfs-drug-trial-begins/
Thank you Mary. I really have to wonder what Dr Davis and his team think about this.
Mary
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Good question! @Janet Dafoe (Rose49), @Ben H, @JaimeS , do any of you know what Ron and his team think of the Cortene trial? or know who would know?
hamsterman
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Wow, it's getting there. As Cort says, once it becomes easy to diagnose.... suddenly the research for cures follows. Kinda like with migraines.
JaimeS
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Not sure right now, but good to ask...
Dakota15
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I'm also very curious to their initial / preliminary thoughts...
Actually there is, Frank comhaire is researching the correct dose of DCA, which gets rid of OEM, including the fluey feeling.