Posted on 01/27/2016 3:33:39 PM PST by PJ-Comix
A national research project is under way to create a small, surgically implanted, and free-standing bioartificial kidney to treat end stage renal disease (ESRD).
The bioartificial kidney will give ESRD patients new hope beyond the short-term solution of renal dialysis and the longer-term, but impermanent, solution of a living kidney transplant for which donor organs are limited.
As well, the bioartificial kidney is expected to save national health care dollars.
When Orlando got back to Miami from almost a year of working as an expert welder in Western Virginia last Spring, I was shocked at his physical appearance. Although he is relatively young at 45, he looked beat. It turned out he was diagnosed with kidney problems. For awhile, it looked like he was successfully fighting the deterioration of his kidneys (genetic since his mother also suffered from kidney failure) by taking baking soda. However, last Christmas Day while I was staying at his home in Miami, he woke up in extreme pain and had to be taken to the hospital. Not long after that he was put on dialysis. We spent New Year's Eve at Jackson Memorial Hospital with him. (I brought a bottle of champagne there but he could not drink it).
Anyway, he will do anything to get off dialyses so I began investigating and found some info, including this article (and video) about bioartificial kidneys. Perhaps I am wrong but it seems only a few months away from becoming a reality as an implant.
Orlando is willing to take the risk and be among the first bioartificial kidney implant patients.
If anybody out there has info on when these implants can become a reality or other info, please FreepMail me. I would like to get Orlando into a program for this as soon as it can become a reality.
Thanx in advance.
I saw this site and it says it is not yet ready for “standard use”. Your brother-in-law’s best bet is to let his nephrologist know that he is interested in this and find out if the doctor can refer him or possibly point the way to getting on a list of volunteers for any experimental treatments involving the bioartificial kidney.
http://www.med.umich.edu/humes/
Prayers up for your brother-in-law.
Thanx for the info but I notice that website is dated Summer 2013. Therefore we are almost 3 years closer from that date. Most of the reports I see now say 2017 for when clinical trials can begin but there is an effort to move up the date. My brother-in-law is willing to take the risk to be among the first for the transplant. I am hoping by perhaps this summer if they move up the start date on the trials.
bump
http://www.ncbi.nlm.nih.gov/pubmed/25553375
Front Biosci (Elite Ed). 2015 Jan 1;7:215-28.
Current strategies and challenges in engineering a bioartificial kidney.
Kim S1, Fissell WH1, Humes DH1, Roy S1.
Abstract Renal replacement therapy was an early pioneer in both extra-corporeal organ replacement and whole organ transplantation. Today, the success of this pioneering work is directly demonstrated in the millions of patients worldwide successfully treated with dialysis and kidney transplantation. However, there remain significant shortcomings to current treatment modalities that limit clinical outcomes and quality of life. To address these problems, researchers have turned to using cell-based therapies for the development of a bioartificial kidney. These approaches aim to recapitulate the numerous functions of the healthy kidney including solute clearance, fluid homeostasis and metabolic and endocrine functions. This review will examine the state-of-the-art in kidney bioengineering by evaluating the various techniques currently being utilized to create a bioartificial kidney. These promising new technologies, however, still need to address key issues that may limit the widespread adoption of cell therapy including cell sourcing, organ scaffolding, and immune response. Additionally, while these new methods have shown success in animal models, it remains to be seen whether these techniques can be successfully adapted for clinical treatment in humans.
Doesn't sound like it will be available anytime soon, but I did not read the article, just the abstract.
God bless your brother-in-law.
Which animals? If it works in them it hopefully will work with humans.
From the article:
To date, the only bioartificial kidney that has shown efficacy in human trials has been the RAD developed by Humes. The RAD demonstrated the proof-of-concept that a biomimetic device could be used to treatment kidney failure. However, the extra-corporeal RAD is impractical for implantable therapy due to characteristics of hollow-fiber dialysis membranes and cumbersome machinery used in the system. Therefore, SNM were developed with unprecedented hydraulic permeability that negates the need for an internal pump and compact geometry that enables an implantable system. Additionally, the BRECS demonstrates that it is possible to overcome many of the logistical obstacles associated with cell therapy. Together, the iRAD concept and advances in the BRECS are advancing towards the goal of making an implantable bioengineered kidney a viable reality.
Conclusions
Renal replacement therapy is an early pioneer in organ replacement. Dialysis, to this day, remains the only long-term extra-corporeal treatment system that is able to provide life-sustaining therapy for a failing organ. This in turn has allowed patients to live for years awaiting a donor kidney on the transplant list. Currently, innovative research is being conducted to address the numerous shortcomings of current renal replacement therapy. These approaches aim to create a fully functional kidney replacement utilizing a cell based therapy approach. Early work has shown promise by developing functional kidney tissue and even prolonging survival following transplantation in animals. Human studies have shown that a cell bioreactor can improve patient’s mortality in acute kidney injury. Despite these early successes, there are obstacles to overcome before a bioartificial kidney will become standard of care. A major issue for the field is cell sourcing. There are ethical concerns over using human embryos and fetal cells for organ development. Furthermore, logistical problems regarding cell-sourcing including cell quantity, cryopreservation, storage and distribution remain before wide-spread adoption can occur. There also remain questions regarding scaffold design and architecture. Additionally, transplantation of donor cells will always raise concerns over immune response in the recipient. Finally, the field will need to move beyond rodents and demonstrate the feasibility of their techniques in larger animals and eventually humans. The current landscape for the development of a bioartificial kidney remains robust with promising new technologies on the horizon. However, the development is still nascent with additional work needed to demonstrate viability in human patients.
Sounds like this technology is not ready for human use yet, but what do I know? I’m not a research nephrologist.
Sounds like he would be better off with standard renal transplant.
Just so you understand, medical device clinical trials go through several phases and it can be a long process that lasts anywhere from several years to a decade. Typically Phase 1 will only demonstrate safety for having the device implanted, but not specifically function. The devices may actually be explanted at the end of Phase 1. Usually a Phase 1 trial will be 6 months to a year.
Phase 2 will study efficacy, but the patient exclusion and inclusion criteria will be very strict. This is where patients are selected by how sick they are (sick, but not so sick they won’t benefit or survive the trial period), they don’t have any past or present mitigating disease, they fill a quota by age and gender, they don’t have a history of smoking or drinking, etc. Phase 2 may last a couple of years. Phase 2 may have a randomized control group that gets a sham device with no functionality (but usually not for life-sustaning devices).
If the results from Phase 2 meet the study endpoints and there is money available to continue, the study then goes to Phase 3 and recruits a much larger patient population with less restrictions on exclusion and inclusion. The Phase 3 endpoints need to be achieved and FDA approval needs to be sought and obtained in order to proceed to Phase 4. Phase 3 testing may last a couple more years.
Finally, in Phase 4 the device is commercially produced and made available to the public, but testing for efficacy and safety still continue.
Therefore we are almost 3 years closer from that date. Most of the reports I see now say 2017
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That’s good news. Remind your brother in law that sometimes “the squeeky wheel gets the oil” when it comes to getting in on medical trials. Good luck!
Thanx. I'm doing the squeaking for him.
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