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TOPIC: Update- bone clinical in Amsterdam The Netherlands

Update- bone clinical in Amsterdam The Netherlands 31 Dec 2012 10:55 #24

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In the blog tool I wrote about Marco Helder´s clinical trial - About biomaterials, ADRCs, Bone experts etc
This clinic is pretty much completed and we might expect results any time soon- at IFATS in Quebec- Helder already provided a glimpse- unexpected but very promising, was his assessment. Here the abstract from the meeting on his study-
BONE AUGMENTATION WITH ADIPOSE STEM CELLS AND CALCIUM PHOSPHATE CARRIERS FOR HUMAN MAXILLARY SINUS FLOOR ELEVATION: UPDATE ON A PHASE I CLINICAL TRIAL
Presenter: Marco N. Helder, PhD
Authors: Helder MN, Prins HJ, Overman JR, ten Bruggenkate CM, Klein Nulend J, Schulten EA VU University Medical Center
For patients with maxillary atrophy, transplantation of autologous bone into the maxillary sinus is the ‘golden
standard’ to achieve sufficient alveolar bone volume (‘sinus floor elevation’) for dental implants. However, autografting has disadvantages, such as limited graft availability, patient discomfort, and donor-site morbidity. Synthetic bone substitutes are used as an alternative strategy, but only allow osteoconduction, since viable osteogenic cells are lacking.
Last year, we presented the outline and some initial findings of our phase I trial, in which osteoinductive implants
consisting of a calcium phosphate (CaP) carrier seeded with freshly isolated adipose tissue-derived stem cells are
generated during a one-step surgical procedure. This novel concept is performed within hours in the operating theatre using a Celution® 800/CRS device, thereby avoiding costly GMP stem cell expansions and a second intervention. Where possible, we use a “split mouth design” with CaP + stem cells on the test side and CaP only on the contralateral control side (allowing efficacy evaluation as well).
Occurrence of any adverse events related to the product and/or procedure are monitored, and from preoperative
phase until one year after implant placement clinical, X-ray, and Cone-beam CT data are collected. After six months biopsies are obtained during the preparation for dental implant placement, and evaluated for bone formation by histomorphometry and μCT.
Currently (May 1), we have included 10 patients. No adverse effects have been observed and/or reported by the patients sofar. Biopsies have been collected from 5 patients, which are now being analyzed with μCT and histomorphometry. Preliminary outcomes show some unexpected but promising efficacy data. B) We will be able to report on the full outcomes of at least these five patients in the October meeting.

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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:

Update- bone clinical in Amsterdam The Netherlands 31 Dec 2012 12:47 #25

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At the same meeting the scientists from the VU (Vrije Universiteit) also presented their results on a pre-clinical study how to improve the trans-differentiation of ADRCs into bone tissue. This is somewhat technical, so just the introduction and the conclusion-

Intro: A one-step concept for bone regeneration has been postulated in which human adipose tissue mesenchymal stem cells (hASCs) are harvested, triggered to differentiate, seeded on biosynthetic substitute carriers, and implanted in the same operative procedure. Toward this goal it was investigated whether short incubation with a physiological dose of BMP- 2 suffices to trigger osteogenic differentiation of hASCs seeded on calcium phosphate carriers.

Conclusion: this study revealed that 15 minutes incubation with a physiological dose BMP-2 had a long-lasting
stimulating effect on osteogenic differentiation of hASCs after culturing on BCP or fl-TCP scaffolds. Our findings
indicate that this short pre-treatment with BMP-2 is a very promising tool for its use in a clinical one-step surgical
procedure, and strongly support a one-step clinical concept for bone regeneration.

In short- adding a growth factor to the cells and let them "culture" by themselves for 15 minutes significantly improves outcomes in differentiation to bone. :woohoo:

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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:
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