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TOPIC: ROBUST trial data

ROBUST trial data 16 Jul 2017 07:58 #9587

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Here is a piece of info that I have come across which is quite interesting. Although the trial did not enrol the specified {270) number of patients, some were enrolled and the data that was recently published is quite interesting.

www.ncbi.nlm.nih.gov/pubmed/27538760

clinicaltrials.gov/ct2/show/NCT01532076?term=robust&cntry1=EU%3ACH&rank=1

Alhough the Basel trial was terminated the initial findings where positive. I suspect that the use of bmp would make this treatment a no brainer.

OA and bone regeneration as per this trial are not so different. We also have positive data from the Dutch bone/dental trial.
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ROBUST trial data 16 Jul 2017 10:00 #9589

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rongside wrote: Here is a piece of info that I have come across which is quite interesting. Although the trial did not enrol the specified {270) number of patients, some were enrolled and the data that was recently published is quite interesting.

www.ncbi.nlm.nih.gov/pubmed/27538760

clinicaltrials.gov/ct2/show/NCT01532076?term=robust&cntry1=EU%3ACH&rank=1

Alhough the Basel trial was terminated the initial findings where positive. I suspect that the use of bmp would make this treatment a no brainer.

OA and bone regeneration as per this trial are not so different. We also have positive data from the Dutch bone/dental trial.


Thanks John- to me extremely interesting. And for the pessimists amongst us- the reason why it was terminated at 8 patients was that there were no takers- i.e. elderly patients do not know -back 5 years ago- about fat cells and their potency. That should change- at least in the US- in due course, as regenerative technology develops.

We knew about ROBUST back in 2011 already and were really excited about it. Actually Calhoun even told me, he didnt know about the trial until I told him. Whatever that statement was worth.

Just to dwell on the difference to OA a bit- both the MSFE study in Amsterdam and ROBUST in Basel are different in that they are surgical procedures instead of non-invasive injections, where you can use osteo-stimulating or osteo-conductive matrices.

That is you sprinkle the cells on a matrix- Basel used hydroxylapatite and Amsterdam β-tricalcium phosphate - the best known osteo-conductive materials around, stuck together with or without a biomaterial type of glue (fibrin) with apparent highly promising results.

For that you need surgery obviously and you cannot get that stuff through a needle.

Anyway- key from the abstract-

We demonstrate that SVF cells, without expansion or exogenous priming, can spontaneously form bone tissue and vessel structures within a fracture-microenvironment. The gained clinical insights into the biological functionality of the grafts, combined with their facile, intra-operative manufacturing modality, warrant further tests of effectiveness in larger, controlled trials.


Conclusion when reviewing this image-



I take this back - I do not know what "BONE REPAIR" could be - we have 2 candidates know, who full fill the conditions.

My guess is now 60% chance bone repair in the elderly with osteoporosis - 40% MSFE. I guess- ( I dont know) the former application has the largest potential.
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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:

ROBUST trial data 17 Jul 2017 23:03 #9598

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Fas et al:

Here is another piece of research from the team at University of Basel:

www.ncbi.nlm.nih.gov/pubmed/27460849

Although it was a trial on mice and not humans the result was quite impressive.

''In the calvarial model, SVF activation of HC using 12 million cells per milliliter of gel induced efficient merging among implanted pellets and strongly enhanced (7.3-fold) de novo bone tissue formation within the defects. Our findings outline a bone augmentation strategy based on off-the-shelf devitalized allogeneic HC, intraoperatively activated with autologous SVF cells''

The above in conjunction with the previous data on humans from the same group would address a huge patient population.
Any rational state/national health care system, not to mention private health care insurance providers should be falling over themselves to fund such trials.

Here is a suggestion to mangement ......... why not go see a couple of insurance companies and offer them some shares. An opporunity to get in early. Wouldn't hurt one way or another. Also how about playing the California based company card wih CIRM. I cannot believe that they don't appreciate the potential of the therapy (and it wouldn't hurt from the PR point of view either - for them & us)

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ROBUST trial data 18 Jul 2017 00:45 #9599

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*** the reason why it was terminated at 8 patients was that there were no takers- i.e. elderly patients do not know***

Sure, I'll be a pessimist.
Your right about no takers but its not like potential takers skim clinicaltrials.gov for potential treatment improvements.
It was my understanding they were comfortable with the current standard of care and didn't want to participate in the trial. ie, no lipo I guess !
Can success in scleroderma and maybe Raynuald's change that ? Perhaps.

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ROBUST trial data 18 Jul 2017 06:04 #9600

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myownhedgefund wrote: *** the reason why it was terminated at 8 patients was that there were no takers- i.e. elderly patients do not know***

Sure, I'll be a pessimist.
Your right about no takers but its not like potential takers skim clinicaltrials.gov for potential treatment improvements.
It was my understanding they were comfortable with the current standard of care and didn't want to participate in the trial. ie, no lipo I guess !
Can success in scleroderma and maybe Raynuald's change that ? Perhaps.


You are probably right in your assessment. It probably makes sense to determine the profiles of the elderly, who tend to get into this 30% category where standard of care fails and the fracture doesnt heal. Or take patients who are into this category and therefore require second surgery. For high risk patients a lipo sure would be more comfortable than another 2 weeks stay in the clinic.

Anyway- on the theme- awareness of the potency of SVF, I think the wild wild west of SC clinics has had positive aspects. At least I can imagine knowledge has increased somewhat. In Japan surely great progress is made in general.

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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:
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