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TOPIC: Any information on knee OA phase 2?

Any information on knee OA phase 2? 08 Oct 2016 16:06 #7747

  • b767cpt
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Has anyone heard any information on the phase 2 OA?

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Any information on knee OA phase 2? 08 Oct 2016 20:40 #7748

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Test...sorry b767...looks like my reply failed to post

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Any information on knee OA phase 2? 09 Oct 2016 09:00 #7749

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C'mon Hedgefund, try again to post re B767's question! :really:

Fas, are you ever coming back - hope all is well with you!

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Any information on knee OA phase 2? 09 Oct 2016 10:41 #7750

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Yeah, I am back already for a few days. Just extended my holidays a bit, which were the best I had in a very very long time... :grin: I even got a tan-



Been rather busy learning about the next steps in my self healing program, which so far had tremendous results, but a long ways still to go.

B767- On OA. Hedrick presented some more data, which none of us can interpret- surely Paul - the ortho doctor-can, but he kind of disappeared, but Hedrick´s statement- based on the pilot = phase 2 results now known, a partner deal should very well be possible, we simply have to wait for that to happen. Only than- I repeat only than- will Cytori spend the 20+ Mio$ required for a pivotal= Phase 3 clinic.

Maybe DOV picked up some more information, but thats the status quo that I have in my head.
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Any information on knee OA phase 2? 09 Oct 2016 13:46 #7751

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Fas, you great in that picture! Welcome back! :joy:

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Any information on knee OA phase 2? 09 Oct 2016 16:28 #7752

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Thanks FAS

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Any information on knee OA phase 2? 17 Oct 2016 08:49 #7781

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FAS,

Normally we think the placebo is saline for perenteral administration and corn starch or glucose for oral doses. In the OA and schleroderma and alopecia trials, what do you think the placebo maybe.

If the placebo choice (should be inactive) is incorrect, the study outcome maybe confusing. (Note: I start to think if Kesten was really up for the job.)

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Any information on knee OA phase 2? 17 Oct 2016 09:08 #7782

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FAS

Another thought:

Regarding the phase 3 schleroderma trial, U of M. did not enroll any patients, As Dr Khana had indicated the study outcomes in this trial depend heavily on the patient selection and I think that study subjects are not the most severe types (no organ involvement and moderate to less severe types). U of M usually sees the most serious kind in which stem cells are used in combination with cytoxan - this combination could lead to death, as reported from both Northwestern and Michigan.

As Hedrick indicated before the current French schleroderma multicenter trials have been slow, primarily due to IRB approvals. I think in view of the lack of acceptable therapy for schleroderma, some IRBs may not accept placebo for the trials, just in many life threatening disease or illness conditions.

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Any information on knee OA phase 2? 18 Oct 2016 03:36 #7787

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franshei wrote: FAS,

Normally we think the placebo is saline for perenteral administration and corn starch or glucose for oral doses. In the OA and schleroderma and alopecia trials, what do you think the placebo maybe.

If the placebo choice (should be inactive) is incorrect, the study outcome maybe confusing. (Note: I start to think if Kesten was really up for the job.)


Franshei-

The clinicaltrials.gov records provide detail on the Placebo used-

OA- Sterile Lactated Ringers Solution (5mL) mixed with ≤ 0.20 ml of the study subject's own freshly drawn blood.
STAR- Sterile Lactated Ringers Solution mixed with small amount of study subject's own freshly drawn blood and administered in 2 injections per digit on both hands.


Ringers solution should be neutral i.e. thats the stuff they use in Puregraft to dissolve fat.

Anyway- in my view, any placebo procedure involving injections into a body part, is somewhat invasive and creates limited damage to the tissue which is involved. That by my definition creates a, albeit limited,response by endogeneous cells at the site of injury. You do not have that with drugs which are orally taken of course... :whistle:

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Any information on knee OA phase 2? 18 Oct 2016 04:15 #7788

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Lets not forget lactated ringers was used in the burn trial for the control...woohoo...still love that one ! :evil:

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Any information on knee OA phase 2? 18 Oct 2016 05:11 #7790

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Fas, scary picture. :really: :grin:

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Any information on knee OA phase 2? 18 Oct 2016 06:01 #7791

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franshei wrote: FAS

Another thought:

Regarding the phase 3 schleroderma trial, U of M. did not enroll any patients, As Dr Khana had indicated the study outcomes in this trial depend heavily on the patient selection and I think that study subjects are not the most severe types (no organ involvement and moderate to less severe types). U of M usually sees the most serious kind in which stem cells are used in combination with cytoxan - this combination could lead to death, as reported from both Northwestern and Michigan.

As Hedrick indicated before the current French scleroderma multicenter trials have been slow, primarily due to IRB approvals. I think in view of the lack of acceptable therapy for scleroderma, some IRBs may not accept placebo for the trials, just in many life threatening disease or illness conditions.


Franshei-
The severe systemic scleroderma treatments at Northwestern were all hematopoietic SC transplants, like they do with leukemia. With other words- the whole marrow is replaced and killed by chemo lethal stuff like Cytoxan (Dr. Burt- link: HERE . The holy grail surely would be treatment without chemo, but why would you take risks with clinics where they outcome is not sure and dose might be a big issue. The sure way as we saw in France is where the cells nicely stick into the fingers. :grin:

I also think the IRB argument for the slow progress in Scleradec II does not apply, since it is only one location- all in Marseille at Assistance Publique Hopitaux De Marseille. The Scleradec III trial starts there too in January 2017 and I still do not understand why they start that one. :whistle:

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Any information on knee OA phase 2? 20 Oct 2016 10:13 #7799

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FAS

Regarding Hedrick's mention of OA partnership discussion (see slides for the Rodman presentation), my thoughts are:

1. The talk may take place in Japan, where OA stem cells treatment is combined with other supportive therapy and life style modification.

2. The talk may not take place in the US. It is foolish for a US device manufacturer to go after the celution - OA indication, based on single dose data. I think a US medical device company would go after a package: scleroderma marketing rights, phase 2 -3 in OA, other celution (local dosing) and CTX-2 (iv dosing) related indications (excluding BARDA thermal and radiation/military uses).

Just my thoughts.

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Any information on knee OA phase 2? 20 Oct 2016 10:35 #7800

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Franshei, I totally agree - any partnership on OA will be in Japan::yep:

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Any information on knee OA phase 2? 20 Oct 2016 11:48 #7801

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franshei wrote: FAS

Regarding Hedrick's mention of OA partnership discussion (see slides for the Rodman presentation), my thoughts are:

1. The talk may take place in Japan, where OA stem cells treatment is combined with other supportive therapy and life style modification.

2. The talk may not take place in the US. It is foolish for a US device manufacturer to go after the celution - OA indication, based on single dose data. I think a US medical device company would go after a package: scleroderma marketing rights, phase 2 -3 in OA, other celution (local dosing) and CTX-2 (iv dosing) related indications (excluding BARDA thermal and radiation/military uses).

Just my thoughts.


I am sticking to Arthrex- to me , they have the right size and expertise to really commit to the science and application. See my posts in the topic OA partner possibilities

Mind you- Japan is a separate case- you do not tackle that market without a Japanese based partner- so those two clinics in Japan probably will become local partners too.

Franshei- you do recall that Hedrick already stated that they DECLINED an offer to partner on Scleroderma in the US, since they want to do that by themselves.

That statement really really upset me tremendously in view of past events. :cry: :cry:

Anyway- if you read the posts in that thread- I raised the money for website publishing through Gofundme in October 2015 and from that perspective a next round should be due this month- I decided to postpone that until the stock price exceeds 15$ though... should be soon enough. :grin:
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