By Bob Marshall, Chief Editor, Med Device Online
In my first year in the Chief Editor’s chair at MDO, one article received more audience comments than any other, by far, but it’s nothing that I can take credit for. It was a news story from early 2016, World’s First Implantable Artificial Kidney Could Enter Human Trials By 2017. As we are poised to enter 2018, it is now obvious that human trials will not begin in 2017, a big disappointment for many of our readers that commented on the article.
Many of the 155 readers who have commented were interested in volunteering for the clinical trials for the artificial implantable kidney, while others are eagerly awaiting commercial availability of the device because they are on hemodialysis due to chronic kidney disease (CKD). My heart goes out to all of them.
I previously worked at a company that developed a home dialysis system, and I learned a lot about renal patients and their lifestyle. Unfortunately, many renal patients have to visit a dialysis clinic every other day, for three or more hours, to have toxins filtered from their blood and have waste fluid removed from their circulatory systems. The whole process is inconvenient at best, and in many cases unsettling; the body builds up the fluid and toxins slowly over several days, and then has them abruptly removed in a few hours. The rapid removal of fluid and toxins from the body is life-saving, but often leaves the patient feeling disoriented, or “washed out,” with what is known as dialysis hangover.
According to the National Kidney Foundation, the top five side effects of dialysis are: low blood pressure, nausea and vomiting, dry or itchy skin, restless leg syndrome, and muscle cramping. People receiving hemodialysis also are at increased risk for sepsis (blood poisoning) and localized infections at the access site(s) on their bodies.
What Is The Kidney Project?
The Kidney Project is a national research team developing a surgically implanted, free-standing bioartificial kidney to perform the vast majority of the filtration, balancing, and other biological functions of the natural kidney. The two-part device leverages recent developments in silicon nanotechnology, membrane filtration, and cell science. It is powered by the body’s own blood pressure, without the need for external tubes and tethers or immunosuppressant drugs.
Unlike conventional hemodialysis, the predicted side effects of an implanted bioartificial kidney include complications like surgical trauma, scars, and infections typical of any implant or transplant surgery. Longer term, patients using the implanted bioartificial kidney might need to increase fluid consumption. The Kidney Project team is led by Shuvo Roy, PhD, a bioengineer and faculty member in the Department of Bioengineering and Therapeutic Sciences in the Schools of Pharmacy and Medicine at the University of California, San Francisco (UCSF).
Kidney Project Timeline
The Kidney Project web page explains why the clinical trials did not start in 2017: “When we said clinical trials would begin in 2017, that was our most favorable scenario at the time. Our projected timeline has always been dependent on obtaining the required funding, and not encountering unanticipated scientific hurdles. We finally raised sufficient money to complete preclinical trials for the Hemofilter just earlier this year. We are now working as fast as we can to complete the preclinical work and have started fundraising specifically for the clinical trials. As such, we have had to adjust our clinical trial timeline accordingly.”
The initial clinical investigation will be a materials safety test of the Hemofilter. During this study, the research team will confirm that all the materials included in the Hemofilter component are safe for human blood exposure. This is the first step of many to receive FDA approval for a completed bioartificial kidney device. Once the initial clinical study is complete and the data analyzed, the research team will apply for a follow-up study to test the Hemofilter’s functional components — namely, its ability to filter human blood.
Subsequent clinical tests will focus on verifying individual components of the Hemofilter before implantation in humans, which is anticipated to occur as soon as late 2018. A truncated series of clinical trials will then be required for the combined Hemofilter and Bioreactor device (i.e., the bioartificial kidney). After these trials are completed, the bioartificial kidney will be commercially available. The research team expects to arrive at this final stage of clinical trials by 2020. This scenario assumes sufficient funding and no unanticipated scientific, technical, or regulatory drawbacks.
Getting Involved In The Clinical Trial
If you are interested in potentially participating in the clinical trials for the implant bioartificial kidney, you should complete this form to submit your information into the Kidney Project’s [confidential] database. Realize that the Kidney Project cannot guarantee anyone’s participation since this is not an official wait-list. They will contact everyone in their database after they receive clinical trial approval, and each clinical trial will include a round of patient selection for involvement.
Until the research team has clearance from its Institutional Review Board (IRB), they are unable to release any patient involvement criteria for their studies. Once each trial receives approval, a team of doctors will begin the recruitment process. Again, the Kidney Project will message all individuals in its database to alert them of progress and provide information concerning next steps. Clinical trials are likely to take place at multiple locations within the United States. As with patient criteria, the location of each clinical trial will not be confirmed until trial approval is granted. However, The first clinical trial likely will take place in San Francisco, CA or Nashville, TN, as these are the locations where the majority of The Kidney Project team is based.
International patients will be considered, but it is likely that the first round of patients will be located in the United States, due both to hospital logistics and operating under FDA guidelines.
Keeping Up To Date With The Kidney Project
The Kidney Project maintains a Facebook page that is a great place to connect with the development team and others in the CKD community. It also helps you to stay informed about the progress and status of the project. In addition you can post items and ask questions.