Welcome, Guest
Username: Password: Remember me
Adult Stem Cell News and Developments other than Cytori
  • Page:
  • 1

TOPIC: Centeno on MSB starting P3 spinal disk

Centeno on MSB starting P3 spinal disk 05 Aug 2015 13:03 #4930

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3299
  • Thank you received: 1110
I think that the blog post he did today on the announcement by MesoBlast that they will start the Phase III of their spinal disk clinic is very important for an orthopedic application.

Sofar - stem cells, at least the kind that MSB, OSIR and ATHX produces have not delivered up to the promise of the pre-clinical- that is large animal-studies.

That caused a shift to deliverables going to creating new "bone" or new cartilage/pulposis tissue, into reducing pain type of clinical goals.

With OA Cytori is to some extent on the same track, but is that enough for a costly treatment versus pain pills??

Time will tell....




This past week Mesoblast, a company pursuing the business model of selling someone else’s mass produced stem cells in a vial launched a major PR campaign to announce their phase III FDA disc degeneration trial. From reading the press releases, you would think that the phase 2 trial showed pure magic. I had reviewed the results of this study last year and was unimpressed, but did I miss something? After all, even for a seasoned physician involved in research, the spin the company put on phase 2 while announcing phase III looked at least superficially impressive. What gives?

I’ve blogged many times about the challenges that companies producing stem cells as a mass produced drug face. The clinical trial results to date have been generally much less impressive than what was sold to investors, who believed that these first stage stem cell companies were going to make the blind see and the crippled walk. However in reality, many companies were left having to “spit shine” trial results that were lackluster and bury negative findings deep in data dumps. One of the issues brought up by a few is that while everyone believed (or was sold) a bill of goods that these mass manufactured cells from someone else’s body would be invisible to the host’s immune system, in reality the host’s immune system does “take out” the cells. In addition, there’s also the issue of what I’ve called the dose arms race, meaning that the companies have such high regulatory approval and manufacturing costs that each claims to be able to grow more doses than the other out of a single donor (to reduce the cost per dose). In the end, cell quality is likely suffering.

So what did the Mesoblast Stem Cell Disc trial phase 2 results for degenerative disc disease show? The therapy involves an off the shelf mass manufactured stem cell injection into a painful and degenerative disc. The press releases tout improvements in pain, function, and disc stability, so let’s dissect those one by one.

First, anyone who follows this company and it’s disc repair technology has to note that something is curiously missing from the press release – MRI changes in the disc. Huh? This company touted that their animal models showed that they could take a dark degenerated, dead disc on MRI and demonstrate disc regeneration on MRI. Why was this important? Because the major US insurers can purchase pain relief for back pain patients with a 5 dollar per month script for a cheap narcotic at Walmart. However, what insurers would pay big bucks for is objective evidence that a stem cell product performed in humans like it did in animals by regrowing new discs. This would surely save the companies potentially hundreds of thousands in future invasive surgeries. However, in both FDA trial press releases (phase 1 and 2), these “holy grail” MRI changes are curiously absent. Note to investors -this is a very big deal. So off the bat, the company has moved it’s product from the “game changing” category to the “super duper expensive pain reliever” category. In the former classification there are no FDA approved drug competitors at any price, in the latter the competition is a plethora of cheap generic narcotic and other pain drugs. Not good…



Continue reading on Centeno´s blog: MSB trial criticized by Centeno

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Centeno on MSB starting P3 spinal disk 05 Aug 2015 13:46 #4931

  • mr5874
  • mr5874's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 80
  • Thank you received: 19
Fas et al,

Do we have any idea on data points that can or will come out of Okyanos? I, for one, am interested because of the amazing results / stories that have been posted to their success page. Realizing they treated their first patient in the Oct/Nov '14 time frame, we are approaching 12 months most likely filled with data points. Just curious... especially when you hear Feshbach talking about how they went with the stem cell leader for cell isolation technology in his recent July interview on Bay 9 News.

Please Log in or Create an account to join the conversation.

Centeno on MSB starting P3 spinal disk 05 Aug 2015 22:30 #4932

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2768
  • Thank you received: 199
Fas, are you wavering on the potential market in OA for Cytori ?

mr5874...some stories have been better than others out of Okyanos.

Please Log in or Create an account to join the conversation.

Centeno on MSB starting P3 spinal disk 06 Aug 2015 01:21 #4933

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3299
  • Thank you received: 1110
Mr5874-

The population of patients treated is highly heterogeneous, so you probably can hardly speak of a distinct population which merits the collation of data and comparing that with something (there obviously are no placebo´s either)

Maybe Lesley Miller will put something together in due course for cardiac patients, which are likely the biggest client base, but am not sure- will ask when the occasion arises. But for the time being its likely to be anecdotal only.

Hedge-

I do admit - that in the present form in which apps are being developed, I think stem cell technology be it the fresh stuff from Centeno or Cytori or the cultured stuff of everybody else, have NOT delivered on the promise that once was there.

That also has a lot to do with the techniques- as mentioned many many times, I see the future of the field not ONLY with paracrine therapeutic action (going now mainly in the autoimmune/anti-inflammatory field) but also in tissue trans-differentiation by using growth factors and other means to coax the cells into what is needed. Regulatory rules presently are too inflexible to accommodate that direction.

On OA- well, KOOS (the primary endpoint) is only partially pain- there is also a lot of inflammation and immune issues in the app that pain killers cannot handle....,

What is the KOOS?

The KOOS questionnaire was developed in the 1990s as an instrument to assess the patient’s opinion about their knee and associated problems. Since the first publication in 1998, the psychometric properties of the KOOS have been assessed in more than twenty individual studies from all over the world. Furthermore, KOOS has been evaluated and compared to other instruments in several reviews (1-8).

KOOS is widely used for research purposes in clinical trials, large-scale databases and registries. KOOS is also extensively used for clinical purposes. In the clinic, KOOS is used to monitor groups and individuals over time. Due to its comprehensiveness, when the questionnaire is completed prior to a consultation, it can be used to guide the consultation as to the symptoms and difficulties experienced by the patient.

KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); i.e. ACL (anterior cruciate ligament) injury, meniscus injury, chondral injury, etc.

KOOS is also used in knee OA. An advantage of the KOOS is the inclusion of two different subscales of physical function relating to daily life, and sport and recreation. This enhances the instrument’s validity for patients with a wide range of current and expected physical activity levels.

KOOS is intended to be used over short- and long-term time intervals; to assess changes from week to week induced by treatment (medication, operation, physical therapy) or over years following a primary injury or OA.

KOOS can be used in research to assess groups and to monitor individuals.

KOOS’ content validity was based upon a literature search, a pilot study and an expert panel (from US and Sweden) consisting of patients, orthopedic surgeons and physical therapists.

KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document: KOOS Scoring). A total score has not been validated and is not recommended. For the purpose of an RCT, KOOS subscale scores can be aggregated and averaged as the primary outcome. The five individual KOOS subscale scores are then given as secondary outcomes to enable clinical interpretation. Please see FAQ for further information on this procedure. The results of the 5 subscales can be plotted as an outcome profile (order of subscales from left to right: Pain, Symptoms, ADL, Sport/Rec and QOL), preferably in a graph with scores from 0-100 on the y-axis and the five subscales on the x-axis (an example is presented in the KOOS User’s Guide, under the heading of KOOS Profile).


KOOS info

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Centeno on MSB starting P3 spinal disk 06 Aug 2015 09:04 #4938

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2768
  • Thank you received: 199
Fas....I once had lofty expectations here, note never the hyper valuations of some, but still quite lofty. I have severely lowered those expectations twice and was just this week considering if those lowered expectations would need lowering again so I was curious on your post. Thanks for the reply !.

Please Log in or Create an account to join the conversation.

Centeno on MSB starting P3 spinal disk 06 Aug 2015 11:49 #4945

  • Wall Street Titan
  • Wall Street Titan's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 875
  • Thank you received: 148
I had corresponded with Mr. Ceteno when these results were released and I agree with his assessment. The back pain data from Mesoblast were unimpressive. However, how is it that Arnold Caplan went out of his way to mention Mesoblast in his latest paper? To reiterate, his main point was that the medicinal benefits of allgeneic MSC therapies do not diminish with successive passes. There are many opinions flying around out there and two of the heavyweights are on opposite sides. We know that Ceteno has an interest in autologous but his analysis seems sound to me. I don't know where Caplan's financial interests lie but we all know his background. Hard to figure.

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 0.101 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites