Human Trials For Artificial Kidney To Begin At The End of 2019, With First Patient Implants In 2020

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"The End Of An Era Of dialysis", this is the suitable title for this medical innovation, artificial kidneys will be ready for human trials at the end of 2019 with first implants in 2020 according to a recent update from the researches responsible for this project.

If approved by the FDA, the breakthrough creation could save thousands of patients currently on the transplant list for a new kidney.

The Kidney Project, which is the coalition heading the contraption’s development, published an update today saying that they have been asked to conduct additional preclinical testing before receiving approval for human trials.

“While the request for additional evidence was not anticipated, it is a measure of the revolutionary nature of our project that there is no precedent for safety reviews of similar technology and materials,” wrote the organization. “In that light, it is understandable that the research ethics boards are requesting additional data to document the safety of the bioartificial kidney.”

The project, which is headed by researchers from the University of California San Francisco (UCSF), the University of Vanderbilt, and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), says that they are optimistic about receiving approval for the trials by late 2019.

The coalition first started causing buzz on the internet after they published their groundbreaking research back in February.

Creating an artificial implantable kidney would be an epic advance in medicine and could address a chronic shortage of donor kidneys needed for transplant. Researchers have been at this quest for the past 15 years and keep coming upon one extremely knotty problem: how to keep the blood flowing smoothly through the artificial device without clotting. In such devices, as blood platelets respond to mechanical forces, they have a natural tendency to clot, causing a device malfunction.

While dialysis saves thousands, if not millions, of lives each year, it is not an ideal solution for kidney disease. Instead of continuous blood filtration, which keeps blood chemistry within a healthy range, dialysis results in ultra-cleansed and nutrient-depleted blood, which becomes gradually more toxic until the following dialysis treatment.

An artificial kidney would provide the benefit of continuous blood filtration. It would reduce kidney disease illness and increase the quality of life for patients. While researchers have made progress on wearable models, to make the device implantable—driven by the body’s own blood flows—the clotting problem would need to be resolved.

The implantable artificial kidney—a bioengineered device that combines a high-efficiency silicon filter and a bioreactor of kidney tubule cells– is designed to accommodate up to a liter of blood per minute, filtering it through an array of silicon membranes. The filtered fluid contains toxins, water, electrolytes, and sugars. The fluid then undergoes a second stage of processing in a bioreactor of lab-grown cells of the type normally lining the tubules of the kidney. These cells reabsorb most of the sugars, salts, and water back into the bloodstream. The remainder becomes urine that is directed to the bladder and out of the body.

The researchers generated simulation and optimization results for two device designs that each channel blood through the artificial kidney filter system. Through simulation, they calculated that an individual platelet may flow through the artificial kidney as many as 1,000 times, accumulating stress and increasing the tendency to clot with each pass. One design distributes blood through parallel channels that pass across multiple layers of filtering membranes. The other channels blood back and forth through a single serpentine path.

Both designs met the researchers’ predetermined criteria for the uniform flow of blood through the devices and accumulation of shear stress forces on the platelets against the walls of the device flow channels.

The simulation approach has accelerated the project by saving on animal experimentation and offering a viable alternative to examine the pros and cons of different devices that contact blood. “To do that in animal studies is time consuming, expensive, and at some level you never know if it is going to work out—because animal blood is not the same as human blood,” said Shuvo Roy, one of the study’s co-authors.

Will the device have all the functions of a native kidney? “No,” Roy said. “But the goal is for it to perform the functions that are critical, and to be a device that, once implanted, will allow a patient to eat and drink freely, have mobility, better health overall, and unlike a transplant, not require immunosuppressant drugs.”

“We are hopeful that the first clinical trial will begin this year,” Roy told Snopes back in March. “If all goes well and funds are available, we could be on the market as early as 2020.”

The Kidney Project says that they have already received an abundance of applications for the human trials. Screenings will proceed once they receive approval from the board of ethics.

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So do it now, lets make history. My son is on dialysis awaiting a transplant at 12 years old. Had his cath put in today and dialysis starts soon. Lost his kidneys to a rare autoimmune wegenera disease.

 

How can I apply for a chance of getting a bionic kidney. Very interested in this project. Thanks, Jacquelyn Dale
[email protected]

 

Please contact [email protected]

 

I lost my left Kidney to clear cell cancer. My right Kidney has chronic Kidney disease. Please help me. 469-235-2477. [email protected].

 

My name is Janet Elton and I have stage 4 kidney failure and am on the kidney transplant list. I have a viable fistula in case my kidneys shut down. I am very interested in getting a bionic kidney. I am open to any clinical trials as well.

 

I am wondering if you're still taking candidates for a bionic kidney ??
Thanks, -jen

 

Hi I am a 46 year old man from baton rouge, La. I have agressive pkd and I am very interested in possibly participating in the clinical trials of the bionic kidney. My kidney function is at about 25 percent. So I am stage 4 renal. Please contact me if at all possible. Thank you.

 

My husband discovered he had a congenital defect of being born with only one kidney when his only kidney failed. Due to aggressive, non-malignant tumors he had that kidney removed. He is not being considered for a transplant. I have been doing his hemodialysis at home for three years. Please. We jave three children who have been watching their father die befor them for 3.5 years.

 

As both dialysis patient and retired Physician's Assistant this scares me b/c the insu companies and Big Pharma will control the market let alone make it so expensive that the common man won't be able to afford it.

 

Bs Bs Bs Bs.. They've beend saying theor going to start clinical trials for years .. literally. Don't believe the BS. Their just out to sell you a dream and take your money.

 

Im Cronic 3B hope that this might be something I can use. Have two Kidneys so on electronic should be easy to compare!

Jeff

 

Where can I find the application in order to be considered for the clinical trials?

 

My husband suffers from stage 3 chronic kidney failure due to systemic lupus nephritis. He has only one failing kidney. Would these trials be available to those who suffer from advanced kidney disease and how do we find out more information.

 

I am stage 5 renal failure with no chance of a transplant because I have antibodies in my blood. I would love to be chosen for the trial.

 

How do patient's contact the The Kidney Project? I am a dialysis patient. I was diagnosed with lupus in 2005 and by 2016 I started dialysis. I have lupus nephritis SLE. And was wondering what I need to do and what many others are wanting to know how do we sign up to be a potential candidate for the trial of this artificial kidney that has been designed. I understand that there are many people that are very curious due to the fact several of us have been waiting on a transplant list or struggle being able to get on one due to health conditions. My email is [email protected].

Thank you for any information that would help myself and others.

 

My husband has been on dialysis for 17 years. He is currently 52 years old. He is very much interested in participating in the trial phase. How does he go about getting an application?