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TOPIC: Mayo - Femoral Head Osteonecrosis trial

Mayo - Femoral Head Osteonecrosis trial 07 Mar 2018 09:12 #11457

  • rongside
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This is the current trial for which we could/should have efficacy results by EOY, of course i is an IIS so we are dependent on their urgency to publish:

clinicaltrials.gov/ct2/show/NCT03269409?term=adipose+celution&cond=Osteonecrosis&cntry=US&rank=1

Past trial undertaken at Mayo using bone marrow was positive:

www.mayoclinic.org/medical-professionals/clinical-updates/endocrinology/stem-cells-studied-as-minimally-invasive-treatment-for-avascular-necrosis-of-the-femoral-head

Chinese investigators had great trial results using BMSC: (BMMSCs were subjected to proliferation in vitro for two weeks, after which about 2 × 106 BMMSCs were harvested)

www.orthonline.com.cn/sites/default/files/bone%20.pdf

Their conclusion:
In summary, obtaining a significantly larger number of BMMSCs
through ex vivo expansion of autologous BMMSCs from a relatively
small volume of subtrochanteric bone marrow aspirated through
the core decompression tunnel is a safe, reliable, and highly effective
procedure. The present study demonstrates the efficacy and safety of
autologous implantation of ex vivo expanded BMMSCs into the femoral
head for the treatment of early-stage ONFH.


The Mayo trial addresses he expansion stage by using ADRC which are readily available in much larger volume and do not require culture expansion. Also the use of Celution addresses the following issues beautifully:

Few hospitals or universities are equipped with cer-tified current GMP laboratories that are suitable for the isolation, expansion, characterization and processing of MSCs. Although private current GMP contract research organizations have emerged to fill this gap, their numbers and locations are limited. Furthermore, cells are being produced, stored and shipped under multiple environ-mental conditions, ranging from room temperature to –196° C (by use of liquid nitrogen); however, not all hos-pitals or outpatient surgical centres have the capability of storing cell products reliably at low temperatures.

Just looked at the CYTX home page banner photos........ just wondering : Take your sweet time geing well ! :bash: :KO:

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Mayo - Femoral Head Osteonecrosis trial 07 Mar 2018 09:35 #11458

  • rodney.strongg
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Rongside, thanks for the informative post - CYTX should have the "get well soon" on the IR page as well -LOL.:grin:

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