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TOPIC: Post-mortem ROBUST

Post-mortem ROBUST 14 Nov 2017 11:14 #10510

  • fas
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Old-timers will remember the YoungFoxes/Cytx-Investor article I wrote on ROBUST, the planned 230 patient clinical trial by Saxer/Ivan/Jakob at the University of Basel, to heal broken collar bones in the elderly with SVF and a matrix. Calhoun at the time even did not know about the clinic until I told him. LOL :grin: That was around 2009/2010 if I recall right.

Many years have gone by- we know now that the procedure works, but there were few takers amongst the patients to be guinea pigs for an unknown technology, so the clinic was abandoned after 8 patients. Still -scientifically sound, a pre-clinical was undertaken and a peer reviewed paper was written on the results, which Cytori claims is one of the reasons that they started the Mayo- hip clinic.

So- as a P. M. so that I will find this back again, when I want to expand on fat-cell.com (assuming Cytori survives) , the abstract from the Basel scientists on ROBUST and its preceding pre-clinical.

Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study

Abstract

Stromal Vascular Fraction (SVF) cells freshly isolated from adipose tissue include osteogenic-and vascular-progenitors, yet their relevance in bone fracture healing is currently unknown. Here, we investigated whether human SVF cells directly contribute to the repair of experimental fractures in nude rats, and explored the feasibility/safety of their clinical use for augmentation of upper arm fractures in elderly individuals. Human SVF cells were loaded onto ceramic granules within fibrin gel and implanted in critical nude rat femoral fractures after locking-plate osteosynthesis, with cell-free grafts as control. After 8 weeks, only SVF-treated fractures did not fail mechanically and displayed formation of ossicles at the repair site, with vascular and bone structures formed by human cells. The same materials combined with autologous SVF cells were then used to treat low-energy proximal humeral fractures in 8 patients (64-84 years old)along with standard open reduction and internal fixation. Graft manufacturing and implantation were compatible with intra-operative settings and led to no adverse reactions, thereby verifying feasibility/safety. Biopsies of the repair tissue after up to 12 months, upon plate revision or removal, demonstrated formation of bone ossicles, structurally disconnected and morphologically distinct from osteo-conducted bone, suggesting the osteogenic nature of implanted SVF cells.We demonstrate that SVF cells, without expansion or exogenous priming, can spontaneously form bone tissue and vessel structures within a fracture micro-environment. 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


Significant Statement


We demonstrate that fat-derived progenitor cells, without expansion or exogenous priming, can spontaneously form bone tissue and vessel structures within a fracture-micro-environment.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.

Link to paper (cost money) - HERE

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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:

Post-mortem ROBUST 14 Nov 2017 15:22 #10511

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Amazing, all the positive things this has going for it and yet the company continues to flounder. The science appears to have worked but management apparently not through the years.

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Post-mortem ROBUST 14 Nov 2017 15:37 #10512

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b7
This also showed the huge acceptance and learning curve in a product like Cytori's
There have been several examples so far.
Incredibly slow SUI enrollment
Limited sick and well off patients flocking to the Bahamas.
India completely fell off the map...big touts there at one time.
The ever revising BARDA contract criteria causing many delays.
We haven't even gotten into all the world governments having their say !

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