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TOPIC: What if OA/Scel fail the same way as ADV/PREC?

What if OA/Scel fail the same way as ADV/PREC? 02 Jun 2015 09:01 #4601

  • cytxer
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We had several trials that had great results but failed to impress in a bigger study, did someone twist the numbers? I don't know, but the bigger studies did not have the same AVG outcome...

What if OA/Scleroderma end up the same way?

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What if OA/Scel fail the same way as ADV/PREC? 02 Jun 2015 09:56 #4602

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You need to be more specific as to which you are referring to.

The early cardiac stuff was stopped with a handful of participants due to safety endpoint. Phase 2 had some complications due to patient high risk set. All cardiac trials had horrible enrollment times.

Breast reconstruction was a questionaire on satisfaction and simply was too expensive.

SUI numbers stink...but as stated before...this is my personal take on the data.

Many small trial data is hidden and seems will always be so.

Not unusual for any company to have late stage trials fail on what earlier looked promising....hence the stages of trials and increase in trial size.
If scleroderma/OA fail its game over. Even if they get approval we need patients willing to have the procedure performed and appropriate reimbursement rates. Cytori has always been a speculative play.

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What if OA/Scel fail the same way as ADV/PREC? 02 Jun 2015 10:07 #4603

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As Hedge indicated, there never have been a "bigger" study which failed. So far everything was tiny tiny and impressive.

With OA at least there is a bit of outside evidence- see : OA thread

The Cellthera results must be repeatable and beatable due to the superiority of Celution.. :yep:

STROMAL VASCULAR FRACTION CELLS FOR THERAPY OF 275 PATIENTS WITH OSTEOARTHRITIS
Presenter: Jaroslav Michalek, MD, PhD
Authors: Michalek J, Kristkova Z, Skopalik J,
Cibulka M, Holek M, Moster R
Cellthera Ltd
Therapy of osteoarthritis relies on non-steroid analgesics, chondroprotectives and in late stages total joint replacement is considered a standard of care. We performed a pilot study using novel stem cell therapy approach that was performed during one surgical procedure. It relies on abdominal lipoaspiration and processing of connective tissue to stromal vascular fraction (SVF) cells that typically contain relatively large amounts of mesenchymal stromal and stem cells. SVF cells are injected immediately to the target joint or to the connective tissue of the target joint. Since 2011, total of 275 patients have been recruited and followed for up to 24 months to demonstrate the therapeutical potential of freshly isolated SVF cells. At the same time, one to four joints (knees and hips) were injected with SVF cells per patient. A total number of 433 joints were treated. Semiquantitative clinical scale evaluation and non-steroid analgesics dependence was used as measurement of the clinical effect, all patients were diagnosed with stage II-IV osteoarthritis using X-ray and ultrasound, in some cases MRI was also performed to monitor the changes before and after stem cell therapy. After 3 months from SVF
therapy, at least 50% clinical improvement was recognized in 95%, at least 75% clinical improvement in 68%, and complete remission in 54% of patients, respectively. Within 1-2 weeks from SVF therapy 85% of patients were off the non-steroid analgesics and remain such for at least 6 months. No serious side effects, infection or cancer was associated with SVF cell therapy. In conclusion, here we report a novel and promising therapeutical approach that is safe, cost effective, and relying only on autologous cells.
This work was supported in part by the International Consortium for Cell Therapy and Immunotherapy ( www.iccti.eu ) and Czech Ministry of Education Grant No.

The following user(s) said Thank You: d9dozrman, fatboy

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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:

What if OA/Scel fail the same way as ADV/PREC? 02 Jun 2015 10:45 #4606

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That's been the major frustration Fas.

If I placed my bet and the trials failed...I don't mind.

The problem has always been execution !!!!!!!!!!!!!!!!!!

Lets hope we get decent enrollment times in the scleroderma trial and it starts at the stated time. I am glad the OA trial enrollment has been going well. Market will recognize this progress and the stabilization of the balance sheet at some point this year. Besides, our new Sabby want to be will want to cash out ASAP I am sure. That alone should mean higher pricing on perhaps mysterious volumes. :bang:

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