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TOPIC: Osteonecrosis Study to start at 3 Mayo Clinic Locations

Osteonecrosis Study to start at 3 Mayo Clinic Locations 26 Sep 2017 08:25 #10091

  • fas
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Surprise surprise. Sometimes it pays to check out my own sites. Cell-therapy.info brings all new developments in the stem cell field- so also this study (works with RSS feeds)

Study name: Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis

25 patients- works with FDA. Link here. HERE

Preclinical and clinical data suggest that ADRC may serve as a safe and efficacious adjuvant agent for the treatment of ON. However, no randomized control study in the United States has formally evaluated safety of ADRC in the setting of ON. Therefore, the primary endeavor of this Phase I pilot study will be to evaluate safety of ADRC for pre-collapse ON of the femoral head.
The Celution System (Cytori Therapeutics, San Diego, USA) for preparation of ADRC from lipoaspirate is currently being evaluated in FDA approved clinical trials including an orthopedic indication (osteoarthritis). In addition, the device has a registration in Europe and Class I approval in Japan. As such, it serves as a known platform that produces a clinical grade product for human use. Other devices on the market process lipoaspirate by either mechanical, washing, or centrifugation methods; however, the remaining components of original adipose tissue are significant and impair the regenerative process. Derivation of relatively pure ADRC has been achieved by few devices and the Cytori Celution System is the only one to our knowledge with a sufficient safety and efficacy track record enabling multiple investigational device exemption (IDE) approvals. The reagent used (Celase®) is of a clinical and pharmacologic grade for use in humans. The production of Celase is free of mammalian products.

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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:

Osteonecrosis Study to start at 3 Mayo Clinic Locations 26 Sep 2017 08:31 #10092

  • b767cpt
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Great find FAS, thank you!
They still have a lot of things in the mill, question for now is financing.

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Osteonecrosis Study to start at 3 Mayo Clinic Locations 29 Sep 2017 18:46 #10098

  • franshei
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Rodney

I am away to see my children and grandchildren in Ann Arbor.

I personally think that the ostereonecrosis study at 3 Mayo locations very interesting.
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