Chronic Kidney Disease and Dialysis patients are eager for the Human Trials to begin for the Artificial Implantable Kidney. The logic is that the sooner the trials begin, the sooner they can determine if (1) the device will be viable, and (2) if there are issues with the device they can be corrected and it may be available for possible market release more immediately. The Research Team for the device that could save hundreds-of-thousands of Chronic Kidney Disease and Dialysis patients' lives has just made a major announcement that has left some patients optimistic for possible trials and others more demoralized and exacerbated (make a person feel worse).
After months of anticipation, the Artificial Implantable Kidney Research Team announced that they received feedback from the Research Ethics boards at the University of California San Francisco (UCSF) and Vanderbilt University, and have been requested to provide more material safety evidence before proceeding with their first patients. "To do this, we will conduct additional preclinical experiments. The bioartificial kidney will be the first-ever blood-contacting device with silicon membranes, and there is no data from other similar devices, said Researchers"
While the Team suggested that the request for additional evidence was not anticipated, they noted that "It is a measure of the revolutionary nature of our project that there is no precedent for safety reviews of similar technology and materials." In that light, it is understandable that the Research Ethics Boards are requesting additional data to document the safety of the Artificial Implantable Kidney.
Once they have more safety data, their findings will be reviewed by the Food and Drug Administration (FDA) and resubmitted to the Research Ethics Boards for possible approval. While this seems like a large undertaking, the Researchers suggested, "It is difficult to estimate exactly when the Clinical (Human) Trial will begin, but we are hopeful that we will have approval for the first Human Trial in 2018 or early 2019."
Recommended Reading: What Happened To The Artificial Implantable Kidney Corporation?
This is a major date change from the "Early 2018" date set previously. Date changes as it relates to groundbreaking research can be expected and the Research Team mentioned that the patients following the Artificial Implantable Kidney "have been part of our journey, and you know how far we have already come!" They are committed to keeping the Chronic Kidney Disease Community up-to-date on progress and thank patients "for your continued patience and support." Still, the news was met with very mixed feedback from patients, including the following real-life comments:
Joan Von Metzinger: Exciting times ahead. God bless you in your testing and keen to see/hear about your successes.
Joy Puglisi: Thank you for your hard work. Sadly my husband passed away to kidney-related complications and was on dialysis. The sooner a replacement for the kidney organ is availaBLE THE BETTER.
Aster Isk: In my personal opinion though, I think this is a bit of bait and switch. You have been asking funding from people at least for the last four years promising clinical trials in 2017. Many people donated to you because of that...
Rachel Taylor: Keep up the good work. You will change so many lives!
Mario Strianese: Been hearing the same story for years!!
Mahendra Ghorpade: Wish you all the best
Colin Roberts: A whole lot of blah blah blah was it approved or not when will it Be approved people are dying and they are playing with lives if anybody in their family needed this they wouldn’t be procrastinating.
Abhishek Singh: Great news!
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