One of my sources which I read up on the latest biotechnology news is the website www.fiercebiotech.com. The type of reader who usually reads these websites are people who are trying to learn about startup companies which are still at a stage where they are willing to accept small investments/funding by semi-rich investors as a type of Angel Investor. The news aggregator website gives small pieces of news that are being released by the startup’s PR department to get people talking.

Something that was mentioned in a few posts from 2-4 years ago was this company called Histogenics which has been trying to get the implanted hyaline cartilage to work out for people who are suffering from osteoarthritis pain. Refer to this article written back in 2012 “Histogenics Closes $49 Million Series A Fundraising to Support Commercial Development of Transformational Cartilage Repair Products“. This is when i started the website and back then I wrote about the technology/product that they have. The old post is “NeoCart Autologous Cartilage Tissue Implant For Cartilage Regrowth And Replacement“. 3 Years later, I think I can give a much more detailed look at their research and give a more educated guess on their future endeavors.

In some ways, what they are doing or trying to do is very, VERY similar to at least half a dozen other research labs I have discovered in the last 3 years. I wrote a post just a few weeks ago about a university research team who is doing something very similar, but the other team has not decided to take their technique out of the lab yet for a larger scale application.

Refer to this section I took from the first link above…

“….Histogenics’ flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implant’s effectiveness is compared to that of standard microfracture surgery.”

Of course this article was from 3 years ago. Now, if you go to the products page (Here) of the Histogenics website, you can see that they are now doing Phase 3. Phase 3 has its description on the website ClinicalTrials.gov, which we are all very familiar with. – Confirmatory Study of NeoCart in Knee Cartilage Repair

It would seem that the information for the Clinical Trial of the NeoCart platform was just updated last month.

Like they said, their approach is… “implantation of an cartilagenous tissue implant derived from the patients own cells.” this is in comparison, to the other well known approach of microfracture surgery.

They even give a contact information if you want to be a subject/patient in their phase 3 clinical trials – Kathleen Large – 18559636227 – NeoCartContactCenter@UBC.com or at NeoCartImplant.com.

From the UBC part, it seems that the implantation process will take place at UBC, which might stand for British Columbia, Canada.

It seems that for the previous Phase, Phase II, the entire process took them 2 full years, You can read up on the results of that full 2 years from this source – Crawford et al. J Bone Joint Surg Am. 2012;94:979-89. This previous clinical trial Phase was done at San Antonio Orthopaedic Group (TSAOG) and headed by Orthopedic surgeon Brad S. Tolin, M.D. They even had a commercial done on asking for people who wanted to join in the treatment.

Let’s summarize the findings of Phase 2, as reported by Histogenics to the SEC (Securities and Exchange Commition), which is what is required for most public companies each quarter. This is what they stated at the very end. (source)

“…Our preliminary findings strongly suggest that using the NeoCart autologous cartilage tissue implant significantly decreases knee pain and improves function within six months after treatment and provides significantly greater improvements than microfracture.”

The Big Questions We Should Be Asking Now

So if you are a regular reader of this website, and you understand the scientific words I use, then you obvious would have realized that I reported in a post just last month of a research team from Ohio State Universtiy who has done what seems to be the exact same thing.

I am referring to the post “Scientists Have Gotten Cartilage To Grow In The Lab From Explanted Seed Chondrocyte Cells And Reimplanted Back Into Patient“. Here, it was from the Wexner Medical  Center and the research group leader (or maybe just spokemen) was a David C Flanigan. A person scraped their knee from a skateboard accident and they lost some meniscus and articular cartilage. The guys as Wexner Medical Lab took some of chondrocytes from his body as a seed, grew it to cartilage, and implanted it into his knee and he seems to okay now.

So are these two groups doing the exact same thing? 

For the final result, no, they are the same thing. However, on their approach, it is slightly different. In the previous post, I wrote that the in-vitro cartilage from OSU when implanted back into the cartilage defect, the most likely result is that while the ACI (Autologous Cartilage Implant) would fuse/bind with the cartilage around it, it generally will eventually develop into fibrocartilage tissue. This is the criticism I gave in that post, and showing that the research that was done at OSU is a step in the right direction, but they just haven’t pushed to a point where I should be giving them too much credit.

At the end of that post, I said that microfracture surgery might be easier, and better than what Wexner has created. Well, in Phase II of Histogenics clinical trials, they showed that their autologous cartilage implantation is better than microfracture surgery. Based on the transitive property (where A>B, and B>C thus A>C), this shows that the Histogenics approach is better than what is available at OSU. Of course, this is assuming that my suggestion at the end of the first post is accurate, that microfracture surgery would be more effective than the stuff Flanigan’s team offered.

The people at Histogenics are able to make a structure that is very similar to hyaline cartilage. This is where they are ahead, at least 1 step ahead. Keep in mind that in the older post, in 2012, they said that they got the in-vitro generated cartilage to be just like hyaline cartilage. I would assume that after 3 more years of research, and then reaching Phase 3, they got the hyaline cartilage down.

To see how far they are at, You can go a little further and do a quick Google Patent Search and type in the word “Histogenics” into the Patent Database. There was a patent called “Acellular matrix implanted into an articular cartilage or osteochondral lesion protected with a biodegradable polymer modified to have extended polymerization time and methods for preparation and use thereof – WO 2005018429 A8“. A 30 second read of the abstract tells you that while creating bone implants is very easy, they state that the patent is technically to treat articular cartilage.

For us, we are now 1 step further!!!

It just seemed like 2 week ago I said that we were maybe 2-3 steps away. Well 2 weeks later, I report to the readers that 1 more step has been taken. We are now essentially 1-2 steps away.

There is seriously just 1 last step to go, but that last step to go from hyaline cartilage for articular cartilage to epiphyseal type will be a big leap. Alsberg is working on it, as well as people like Gordana Novakovic. Alsberg has already jumped into the last step, trying to get it to work. However, no one has yet been willing to go from the 2nd to last step to the final step yet. This is where we will see real funding into the venture come about.

What do we need to see to make take the final step?

We would need the funding from a billionaire source. I read just today from MIT Technology Review that the Paypal billionaire Peter Thiel has put in funding to the cancer fighting startup StemCentrx. He talked about the fact that Biotech funding is very tricky. Conventional biotech research is sort of like a shotgun approach, where you try thousands of combinations of stuff and hope one has a useful result. Thiel realises that to make biotech startups less costly, and easier to fund, biotechnology has to evolve to a point, where research is more of a sniper-approach, where the element of randomness is reduced, and you can actually predict and design out what you want for a result. The book that I am writing currently, which I predict won’t be finished for another 3-4 years, will be the step that Thiel is talking about, where we predict and design the exact steps to take the final step.