This isn't actually about stem cells, but I think it's relevant enough to post here. For people like me with osteoarthritis, a renowned bioengineer by the name of Dr. Kyriacos Athanasiou, Chairman of the Department of Bioengineering at UC Davis, has developed the technology to biologically resurface an arthritic joint using tissue-engineered articular cartilage fabricated in the laboratory, and has succeeded in using it to resurface the joints of animals.
Photo:
http://postimg.org/image/tjgqw1igj/
Video (his part starts at 20:00):
https://www.youtube.com/watch?v=1wveBKa815A
I recently contacted Dr. Athanasiou to inquire about the status of this technology and ask when it will be used in humans. I've pasted the relevant excerpts from the exchange below (his replies are in bold text):
_____________________
Dear Brian,
Below in your original email you will find very brief responses. I am sorry in advance that I cannot provide fuller responses to such inquiries. The best of health.
Kyriacos (Kerry)
Kyriacos A. Athanasiou, Ph.D., P.E.
Distinguished Professor of Biomedical Engineering and Orthopaedic Surgery
Child Family Professor of Engineering
University of California Davis
Editor-in-Chief, Annals of Biomedical Engineering
xxxxxx@ucdavis.edu
http://bme.ucdavis.edu/people/departmental-faculty/athanasiou/ (BME)
http://www.bme.ucdavis.edu/athanasioulab/ (lab)
http://www.ucdmc.ucdavis.edu/orthopaedics/ourteam/biodetail.asp?bioid=1481 (Orthopaedic Surgery)
On 7/2/2015 4:26 PM, Brian Gates wrote:
>
> My questions:
>
> 1. What is the status of tissue engineering with respect to the goal of resurfacing entire joints afflicted with OA? In a 2012 speech at the UC Davis Stem Cell Dialogues, you announced that your lab has succeeded in creating the entire articular surface of a human distal femur; however, your book “Articular Cartilage” published the following year states that there is still no successful tissue engineering approach to treating OA. Can you explain the apparent contradiction? Will your “HyCart” product include constructs capable of resurfacing whole joints as opposed to ones intended to repair focal defects only? And if biological whole-joint repair it isn’t already on the horizon, can you comment on whether you see it as a future likelihood and how distant the prospect is? Is it a goal of yours?
>
I am not pursuing commercialization of any products currently. In the lab we have been able to resurface entire joints of animals, but we have not done so beyond the lab. It is a goal of ours but with the way the FDA requirements are it will take a long time to achieve. The reason is that engineered biological tissue is one of the most complicated pursuits in terms of regulatory processes. I am glad that the FDA has rules and regulations; it is just this particular objective is one of the most difficult ones to pursue. Because of the regulatory complications, there is no funding by investors toward this goal (they prefer snapchat and facebook). I cannot provide any timelines for commercialization.
>
>
>3. I am deeply concerned that that regulatory burdens will delay patient access to tissue engineering and regenerative therapies for long after they become technologically feasible. My understanding is that the FDA considers every diseased joint a discrete “indication,” implying that biological joint resurfacing products may have to go through separate approval processes for all of the different joints in which they are to be used. If this is the case, it seems that there is likely to be a very long wait before a tissue engineering therapy for OA can be used anywhere in the body it is needed. Is this inference correct, or do you see a way around this?
>
>
I guess I anticipated this question in my answer 1 above. I share your opinion fully
Photo:
http://postimg.org/image/tjgqw1igj/
Video (his part starts at 20:00):
https://www.youtube.com/watch?v=1wveBKa815A
I recently contacted Dr. Athanasiou to inquire about the status of this technology and ask when it will be used in humans. I've pasted the relevant excerpts from the exchange below (his replies are in bold text):
_____________________
Dear Brian,
Below in your original email you will find very brief responses. I am sorry in advance that I cannot provide fuller responses to such inquiries. The best of health.
Kyriacos (Kerry)
Kyriacos A. Athanasiou, Ph.D., P.E.
Distinguished Professor of Biomedical Engineering and Orthopaedic Surgery
Child Family Professor of Engineering
University of California Davis
Editor-in-Chief, Annals of Biomedical Engineering
xxxxxx@ucdavis.edu
http://bme.ucdavis.edu/people/departmental-faculty/athanasiou/ (BME)
http://www.bme.ucdavis.edu/athanasioulab/ (lab)
http://www.ucdmc.ucdavis.edu/orthopaedics/ourteam/biodetail.asp?bioid=1481 (Orthopaedic Surgery)
On 7/2/2015 4:26 PM, Brian Gates wrote:
>
> My questions:
>
> 1. What is the status of tissue engineering with respect to the goal of resurfacing entire joints afflicted with OA? In a 2012 speech at the UC Davis Stem Cell Dialogues, you announced that your lab has succeeded in creating the entire articular surface of a human distal femur; however, your book “Articular Cartilage” published the following year states that there is still no successful tissue engineering approach to treating OA. Can you explain the apparent contradiction? Will your “HyCart” product include constructs capable of resurfacing whole joints as opposed to ones intended to repair focal defects only? And if biological whole-joint repair it isn’t already on the horizon, can you comment on whether you see it as a future likelihood and how distant the prospect is? Is it a goal of yours?
>
I am not pursuing commercialization of any products currently. In the lab we have been able to resurface entire joints of animals, but we have not done so beyond the lab. It is a goal of ours but with the way the FDA requirements are it will take a long time to achieve. The reason is that engineered biological tissue is one of the most complicated pursuits in terms of regulatory processes. I am glad that the FDA has rules and regulations; it is just this particular objective is one of the most difficult ones to pursue. Because of the regulatory complications, there is no funding by investors toward this goal (they prefer snapchat and facebook). I cannot provide any timelines for commercialization.
>
>
>3. I am deeply concerned that that regulatory burdens will delay patient access to tissue engineering and regenerative therapies for long after they become technologically feasible. My understanding is that the FDA considers every diseased joint a discrete “indication,” implying that biological joint resurfacing products may have to go through separate approval processes for all of the different joints in which they are to be used. If this is the case, it seems that there is likely to be a very long wait before a tissue engineering therapy for OA can be used anywhere in the body it is needed. Is this inference correct, or do you see a way around this?
>
>
I guess I anticipated this question in my answer 1 above. I share your opinion fully