It's been two years since we first announced we'd be launching clinical trials for SCD-101, the drug equivalent of our supplement Xickle RBC-Plus. A necessary part of our journey toward FDA-approval, the initial phase of our clinical trial has already demonstrated the effectiveness of Xickle on patients with sickle cell disease.
In fact, in the December 2016 issue of Blood, the American Society of Hematology’s weekly medical journal, an article was published illustrating the initial successes of our trial. The feature, “SCD-101: A New Anti-Sickling Drug Reduces Pain and Fatigue and Improves Red Blood Cell Shape in Peripheral Blood of Patients with Sickle Cell Disease,” points out that participants in phase one of the trial not only showed reduced occurrences of cell sickling, but also reported an increase in exercise ability, as well as improved sleep and ulcer healing, leading the researchers to conclude that SCD-101 is a “promising new drug for the treatment of sickle cell disease.”
Fast forward a few months, and because of the success of the initial round, we are now preparing to enter the next phase in our dose-escalation study: a randomized, double-blind, placebo-controlled crossover. Here’s how it’ll work: Participants will be randomized to two treatments—placebo and SCD-101. Some will receive 28 days of the placebo first, followed by 28 days of SCD-101, while others will receive the drug first, followed by the placebo. This method helps compare the two treatments using a relatively small sample size. To ensure accuracy, a 28-day “washout” period—when clinical trial participants are completely taken off a study treatment for a set amount of time—will follow each 28-day treatment period. This just guarantees that there will be no “carry-overs” or leftover effects of the first treatment into the second one.
This next phase of the trial will continue to test the safety and effectiveness of escalating doses of SCD-101—things like changes in sleep and exercise activity, pain incident and pain reliever usage, fatigue symptoms, and of course, sickling frequency. We expect to continue to see positive reactions from sickle cell warrior participants.
The best news, though? While FDA approval for the official drug development of SCD-101 may take another four years, you can purchase and use SCD-101 in its supplement form, Xickle RBC-Plus. With no known toxicity, Xickle helps prevent sickling in both children and adults. Why wait to get started?
For even more info on Xickle RBC-Plus/SCD-101, check out the video below:
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Clinical Trial Update: Our Product Has Been Recognized as an Effective Treatment for SCD
April 18, 2017 by AndreaCategory: Clinical Trials Tags: clinical trials, SCD-101, sickle cell treatment | Comments Off on Clinical Trial Update: Our Product Has Been Recognized as an Effective Treatment for SCD
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Another Milestone in Our Quest for FDA Approval
March 9, 2015 by Andrea
Just three months in and already 2015 has been off to a good start for Xickle. In January, we announced plans for a clinical trial; in February, we published a brief preview of our research; and this month, we've not only been a part of an amazing sickle cell-centric radio show, but now, we're excited to share that our clinical trial has officially been published on clinicaltrials.gov!
To summarize, our clinical trial is studying the safety and clinical effects of SCD-101 (the drug equivalent of Xickle RBC-Plus) in adults with sickle cell disease. Effectively identical to Xickle RBC-Plus -- it's made in the same plant, by the same process, and bottled by the same company -- SCD-101 "inhibits sickling of red blood cells containing Hb S (sickle hemoglobin) under low oxygen conditions ... SCD-101 may inhibit red blood cell sickling in patients with sickle cell disease and reduce symptoms and slow disease progression."
We believe so strongly in our product and have seen how it has positively affected our current users, so this trial is quite significant since it's bringing us one step closer to FDA approval, ultimately giving us solid credibility as a treatment for SCD. While we work through the approval process (which can take 4-6 years), we will continue to offer Xickle RBC-Plus as a supplement via our website.
To learn even more about our current clinical trial, including criteria, outcome measures, and important dates, read more here -- and of course, spread the word!
Are you excited about this clinical trial? Have any questions? Tell us in the comments below!Category: Clinical Trials, Sickle Cell Disease Tags: clinical research, clinical trials, FDA approval, innovation, patients, Red Blood Cell Health, sickle cell disease, technology | Comments Off on Another Milestone in Our Quest for FDA Approval
