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TOPIC: Scleradec-I news question

Scleradec-I news question 13 Apr 2015 07:58 #4165

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Fas, what do you think about this last line in today's news?

**While the average hand pain at 12 months was lower than that at baseline (reflecting overall symptom improvement over baseline), there was an approximately 50% reduction in the average therapeutic benefit on hand pain from six to twelve months **

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Scleradec-I news question 13 Apr 2015 08:07 #4166

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Fas, what do you think about this last line in today's news?

**While the average hand pain at 12 months was lower than that at baseline (reflecting overall symptom improvement over baseline), there was an approximately 50% reduction in the average therapeutic benefit on hand pain from six to twelve months **


That the therapeutic benefit decreases over time for a localized procedure is not all that surprising. The root cause does lie in the auto-immune disorder itself of which the symptoms- the impact on hands for 90% of patients are treated.

Either the patients get "top ups" from cryopreserved material in the hands or at a later stage a systemic (IV) treatment to combat the underlying cause.

Rongside will tell you that this surely is to come with lots of other auto immune disorders... :grin:
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Scleradec-I news question 13 Apr 2015 08:20 #4169

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But we are not doing (IV) treatment in this pivotal, are we? or is it yet to be decided?

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Scleradec-I news question 13 Apr 2015 08:24 #4170

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I'm surprised that the pain benefit decreased without other decreases in benefits as well in that inflammation etc causes the pain, but I hope these sufferers can regain--or keep--the initial benefits in hand function with another treatment of ADRCs and that the pain can be managed with less medication.

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Scleradec-I news question 13 Apr 2015 10:26 #4172

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But we are not doing (IV) treatment in this pivotal, are we? or is it yet to be decided?


Correct. We are not doing IV.

That is fine really- we have to take step by step by step and take the FDA by the hand to prove safety and effectiveness in the micro-infrastructure of different tissues.

IV will than come X years later X at least > 5, after more experience is gathered across the globe including Okyanos etc etc...

Problem is- these first steps should have already been taken many many years ago and not in 2015... :cry:

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Scleradec-I news question 13 Apr 2015 11:38 #4174

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***Problem is- these first steps should have already been taken many many years ago and not in 2015... :cry:***

Agree but CC thought he could sit back and do little and leave it to the academics to run the trials for him and everyone would be screaming to partner. A flawed plan from the beginning that I never liked but was supported by even some here. Now, they have taken control, but focus must be limited with the always present cash situation and the ever increasing number of outstanding shares. I still believe CYTX will never be what it could have been but we still have a chance of success in improving lives and hopefully a investment reward.
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Scleradec-I news question 14 Apr 2015 20:54 #4202

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FAS is right that the overall development for the scleroderma indication would be stepwise over many years.

I personally think that the EU 12 patients data at 12 months is very meaningful-the response duration with just one dose appears to be at least 12 months. Can patients receive another dose to extend duration?

In the future with more universal clinical experiences, maybe patients will be dosed locally and then by iv route (to enhance the nature of response and duration). But, first thing first.

I think all the PIs and co-PIs may have a plan, which should have been presently to the FDA before and during the IND submission. The fact that 20 out of 35 scleroderma centers in the US are now involved in the study is very meaningful: the IDB must be very convincing for a proposed treatment of this dreadful sickness (while there is no current cure/even palliation).
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Scleradec-I news question 15 Apr 2015 07:47 #4207

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I think all the PIs and co-PIs may have a plan, which should have been presently to the FDA before and during the IND submission.


Franshei-

Remember, there was no IND (drug) submission even if the output of Celution now have different product names.

Cytori applied for - that is for OA and scleroderma- an Investigational Device Exemption- i.e IDE (Class III PMA) clinics. Cytori would have pursued orphan status too in the US if they would have to do an IND. However Hedrick mentioned that the device pathway is simply less cumbersome and expensive and can be expedited in a timely fashion relative to IND and orphan status.

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Scleradec-I news question 16 Apr 2015 06:57 #4222

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The 12 month data was excellent in my opinion. It showed that the benefits of the single dose continued for 12 months as depicted in the CHFS, RCS, and SHAQ scores, These were similar to the initial 6 month scores which showed substantial improvement. These scores are considerably less subjective than pain and for that reason of greater value.

As regards pain, this is very much a subjective measure. I would hazard a guess that patients have reset in their own minds the "new normal" level of pain. As they attempt ever more strenuous attempts of hand movement (because they now can) this is reflected in their assessment of pain. Also the "new normal" level of pain in their minds reverts to the level prior to treatment ......... all very subjective conjecture no doubt (like pain) :bash:

It would be great to test the benefit of additional injections into the fingers using cryo-preserved SVF. This will no doubt happen very quickly at the first indication of success on the basis of the single treatment.

Our penetration of the major Scleroderma treatment centers is crucial in getting this trial completed quickly, something I believe is very possible. It will also facilitate the quick introduction of the product to the US patient population. It goes wihtout saying that if successful in the hand manifestation we will very quickly see it tested intravenously in more severe cases of systemic scleroderma.

My personal hope (for 10XWD) is to see this treatment adopted for rheumatoid arthritis and similar AI diseases. Given the initial success in Scleroderma and the testing of SVF in osteoarthritis there is a good chance the Celution device could totally change the way these conditions are treated. :grin:

My expectations for 10XWD are considerably diminished from when Dean first used the term :cry: , but if successful can still be quite substantial.
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Scleradec-I news question 21 Apr 2015 14:23 #4305

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Rongside, I agree with you in part. But, these questionnaires often ask things like "Are you able to ...". That is less subjective than "Do you feel pain when..."

That brings me to my question: does anyone know what the "Scleroderma Health Assessment Questionnaire" actually looks like?

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Scleradec-I news question 21 Apr 2015 16:19 #4311

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This link leads to an article "Measures of Systemic Sclerosis (Scleroderma)", including information, but no details on the SHAQ.

onlinelibrary.wiley.com/doi/10.1002/acr.20598/epdf

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