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TOPIC: Some more OA data with SVF

Some more OA data with SVF 03 Jul 2016 08:36 #7366

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I presume it will not take all that long before the OA data will be released (again- the 48 weeks point was Mid May or so), so we might as well take a look whats out there from similar technologies....

Hedrick´s former colleagues at Pittsburgh (who own the composite of matter IP on adipose stromal cells i.e. the 231 patent ) founded several years back the Company- The GID Group- Those colleagues were Adam Katz and William Futrell with whom he also founded StemSource.

They do not seem to be going anywhere fast, but already did a feasibility study on 10 knees which they reported upon last year-

Objective: Autologous adipose-derived stromal vascular fraction (SVF) was used to treat ten osteoarthritic knees of grades II or III (K-L scale) under an IRB-approved protocol in a feasibility and safety study. The primary objective of this study was to determine if adipose-derived SVF can be safely used for intra-articular injection of the knee. The secondary objective of this study was to evaluate the feasibility of an intra-articular injection of adipose-derived SVF for pain relief in osteoarthritic knees.

Methods: 10 knees in 6 patients were treated with an intra-articular injection of adipose-derived SVF; patient ages ranged from 52-69 years with a mean of 59 years. Adverse events were monitored for indication of safety. Patient pain data was obtained at 2, 4, 6, and 12 weeks follow up using the PROMIS questionnaire and a pain and mobility questionnaire. The t-test for paired data (2-tailed) was used to assess statistical significance of the PROMIS data and Wilcoxon Ranked Sums nonparametric testing was used to access statistical significance for the pain and mobility questionnaire. Stromal vascular fraction was obtained through disaggregation of lipoaspirate and resuspension of the cell pellet in 3 ml of Lactated Ringer’s Solution, with a mean of 48 million nucleated SVF cells and a mean viability of 78%, injected per knee. Cell suspension was injected into the intra-articular space using ultrasound guidance.

Results: (1) No infections, acute pain flares, or other adverse events were reported related to an intra-articular injection of adipose-derived SVF in the knee. (2) At 12 weeks post-op all 10 knees showed decreased pain and increased mobility (α=0.01). Nine of ten knees reported either maximum possible or very significant decrease in pain.

Conclusions: Use of autologous adipose-derived SVF in the knee is a promising cell-based therapy that addresses a significant clinical need with no known regenerative solution. A larger clinical efficacy study is needed that includes a control arm and extended follow-up data at time points including six months and one year.


Anyway- they started a study with 37 patients this year- the record you can find here : HERE


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Some more OA data with SVF 03 Jul 2016 08:47 #7367

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Another recent reporting event came from the ADIPOA consortium in Europe, which is a group of French and German academic investigators lead by this guy Christian Jorgensen from the Montpellier University, who also presented at the European Cellsociety meeting in Marseille.

They use cultured ADRCs i.e. culture the MSCs only. I read some statements from the guy and he seems convinced that the future ONLY is into cultured stuff. Totally silly and inflexible thought processes applied, in my view.

For your info the paper which was recently published- keep in mind both technologies have to go the drug route of regulatory approval... :whistle:


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Some more OA data with SVF 03 Jul 2016 09:34 #7369

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Purpose
This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.

How is this a pivotal study? It reads like a phase II-b dosing study just like ACT-OA. Any thoughts, Fas?

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Some more OA data with SVF 03 Jul 2016 09:52 #7370

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DOV wrote: Purpose
This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.

How is this a pivotal study? It reads like a phase II-b dosing study just like ACT-OA. Any thoughts, Fas?


Yes- I read that too, but opted to simply ignore that, since you simply cannot have a pivotal study with 37 patients and they even do not have a pilot, since the feasibility study was without the GID 700 device. On top of that- everything except Celution will be drug and not PMA device, so maybe we should not take them too seriously - just take note that they are there, which I know already for 3-4 years or so.

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Some more OA data with SVF 04 Jul 2016 09:30 #7375

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fas wrote: On top of that- everything except Celution will be drug and not PMA device....


I have to correct myself- from the Cytori notes of the draft legislation :

The draft guidelines contain several points worthy of highlight:
· The clinical use of cells isolated from human tissue, no matter the isolation process, and including cells derived from adipose tissue, will require FDA oversight.
· The process of extracting any cell population or cellular subset from adipose tissue will be considered beyond the technical process of ‘minimum manipulation’. Minimal manipulation means a process that does not change the relevant biological characteristics of a cell or tissue.
· The clinical use of an isolated cell population will not be considered exempt under the technical definition of ‘same surgical procedure’. The same surgical procedure exemption is important because it was the legal mechanism that allowed physicians to legally utilize cell isolates from tissue on the same patient. This exemption has now been redefined to require ‘minimum manipulation’ as a new requirement for the exemption.
· Adipose derived cellular products may be regulated through the investigational drug pathway (as a drug or biological product) or as a PMA device at the discretion of the FDA.
· Any party, in the US, extracting cells from adipose tissue for use as a therapeutic will be required to obtain a biologics license from FDA to commercialize the product or obtain approval for an IND or IDE to pursue a clinical investigation. Products with formal device designation from FDA are eligible to proceed to market through a PMA device pathway where device regulations are applied versus the very different pharmaceutical regulations.
· Physicians can no longer make their own cell therapies from adipose tissue without FDA oversight.


So -others doing PMA´s when allowed by CBER is a possibility. :whistle:

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