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TOPIC: VU Amsterdam Bone Study Published

VU Amsterdam Bone Study Published 19 Jul 2016 07:42 #7431

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This is what Marco Helder has been talking about at IFATS for the past 3-4 years. Follow up on patients was now for 3 years- this obviously works too... :grin:

Jul 19, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of the results from an investigator-initiated Phase I trial using Cytori Cell Therapy in patients with insufficient maxillary bone prior to dental implantation. The publication reported approximately 42% greater bone formation in maxillary sinus floor elevation (MSFE) procedures treated with cells in combination with scaffolds versus those that received scaffold alone.
The study, conducted by investigators from Departments of Orthopedic Surgery, Oral and Maxillofacial Surgery, and Oral Cell Biology of the VU University in Amsterdam, The Netherlands, enrolled 10 patients requiring dental implants but who had insufficient bone into which the implant could be inserted. The maxillary bone deficiency was treated with two different commonly-used, off-the-shelf bone calcium phosphate scaffolds that were used either alone or pre-loaded with Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori’s Celution™ System. In six patients, the patient served as their own control as one side of the mouth was treated with scaffold alone and the other side was treated with ADRC-supplemented grafts. Six months after treatment all patients underwent dental implant placement at which time a biopsy of the regenerated bone at the graft site was performed.
The trial results reported approximately 42% greater bone formation in grafts that were supplemented with ADRCs. Specifically, in patients who received both a control scaffold and a contralateral ADRC- supplemented scaffold, the ratio of bone volume to total graft volume as measured by micro computerized tomography (microCT) was 19.5% ± 3.8% in grafts supplemented with ADRCs versus 13.7% ± 4.4% for the control grafts (p = 0.03). A similar trend was seen by histologic assessment of biopsies. They also noted that all 10 patients were treated uneventfully, with no adverse effects reported or detected in a large set of safety parameters through =3 years of follow-up.
Regarding the findings, the authors stated: “A striking observation from the histomorphometric and micro-CT analyses was the active bone formation observed at the cranial side of the biopsies in 7 out of 10 of the selected bone biopsies taken from the study [ADRC-treated] side, but only in 1 case from the control side. To our knowledge, this phenomenon has never been described before and may be unique to the current set-up.”
The American Academy of Implant Dentistry reports that approximately 500,000 patients receive dental implant surgeries in the USA every year. A recent report estimated that the global market for dental implants is projected to reach $5.8 billion by 2022. Use of calcium phosphate scaffolds for bone repair and reconstruction is also common in orthopaedic surgery.
The paper is titled: “Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics” published in the journal Stem Cells Translational Medicine. A link to the abstract can be found here. A full copy can be obtained without charge by registering with the publisher.

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VU Amsterdam Bone Study Published 19 Jul 2016 07:46 #7432

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Helder is a vehement proponent of the "one-step-surgical-procedure" as he calls it....that was nicely depicted in the paper, which you will find attached..

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VU Amsterdam Bone Study Published 20 Jul 2016 06:52 #7437

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I received a few comments from dentists about this press release. All stated the market is large. Here is one quote:

Very promising, Lewis. This is a huge market. When a tooth is lost, the supporting bone, called alveolar bone, just goes away. The longer a patient waits to have the tooth replaced, the greater the defect becomes. This occurs regardless of age. Replacing this bone would be huge both in the terms of function, but also aesthetics when the missing tooth is in the anterior region of the mouth.
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VU Amsterdam Bone Study Published 20 Jul 2016 08:29 #7439

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DOV wrote: I received a few comments from dentists about this press release. All stated the market is large. Here is one quote:

Very promising, Lewis. This is a huge market. When a tooth is lost, the supporting bone, called alveolar bone, just goes away. The longer a patient waits to have the tooth replaced, the greater the defect becomes. This occurs regardless of age. Replacing this bone would be huge both in the terms of function, but also aesthetics when the missing tooth is in the anterior region of the mouth.


Yes- I also happen to know that a dental application study started in Japan about 3 years ago too. This was in the timeframe when Chris C. was so proud that 20% of the SC studies in Japan was fat cell based with the cells prepared by Celution.

I never understood why Olympus snubbed Cytori- it still does not make sense from a strategic perspective, especially with the new regenerative law in force. Besides being the global market leader in gastro devices, their JV with Terumo- i.e. Olympus-Terumo Biomaterials -link HERE has all the marketed and successful synthetic bone replacement materials - and I always said and still say- that bone replacement materials also need the living cell. :whistle:

This study proves I am right- the article on fat-cell.com is also on the same theme... :grin: :nice:

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VU Amsterdam Bone Study Published 20 Jul 2016 11:14 #7441

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Dov,

I had a root canal go bad on me. I had to have the tooth extracted and get an implant. When they extracted the tooth they filled the cavity left by the root in the jaw with cadaver bone in a paste. This is done to keep the underlying scaffold of the bone structure intact until healing occurs and the implant can be done. I think that the additional of stem cells to the mix is a way to promote autologous tissue growth. With the increasing number of implant procedures taking place this could be a very large market.

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VU Amsterdam Bone Study Published 20 Jul 2016 11:50 #7442

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On the dental subject, few may remember Cytori doing work on receding gum disease.
Cant remember if we ever got beyond rat treatment but the results were very good.
I find it similar to acute MI treatment....getting to the problem before even more damage is done.

Anyway, with aging populations imagine the size of such a market.
BTW, there have been those who have linked gum disease and general dental health with cardiac health !!!!

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VU Amsterdam Bone Study Published 20 Jul 2016 12:19 #7443

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myownhedgefund wrote: On the dental subject, few may remember Cytori doing work on receding gum disease.
Cant remember if we ever got beyond rat treatment but the results were very good.
I find it similar to acute MI treatment....getting to the problem before even more damage is done.

Anyway, with aging populations imagine the size of such a market.
BTW, there have been those who have linked gum disease and general dental health with cardiac health !!!!


Receding gum- my youngest sun had that as a problem. Even had very painful surgery where some tissue from the bottom jaw was transplanted to the upper jaw (or the other way- do not recall). Did not work though and he was about to do a "face job" on the attractive female surgeon. Fortunately Vitamin D3 resolved all the issues. I have the same observation- all teeth simply seem to be "locked up steadier" compared to the past.

Anyway- on the bone growth stuff- as fatboy mentioned cadaver bone is used, auto bone (from the iliac crest) and several synthetic things like the things I linked to the Olympus Terumo pages and the BMP 2 &7 compounds. The last ones have substantial issues, which Medtronic & Co nicely shove under the bushells due to their financial power. What I am trying to get at- the musculoskeletal system has a few more parts- after water, muscle and fat I believe number 4 with 10-12% or so of the human body. Fat cells as therapeutic, are still unknown to most- I notice that when I talk to medical folks, they do not have a clue- but that will not stay forever that way.

Plenty opportunity here. :vegas:

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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:

VU Amsterdam Bone Study Published 20 Jul 2016 12:36 #7444

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maxim.bluematrix.com/sellside/EmailDocViewer?encrypt=0893988c-a12d-4745-95e5-7cc30ae486de&mime=pdf&co=maxim&id=mroth619@aol.com&source=mail

Link is for Maxim report on topic. Have to laugh Kolbert has target price for CYTX at $5, which is where he had it pre reverse split, I guess he knew it was coming and never has changed his target.

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VU Amsterdam Bone Study Published 21 Jul 2016 07:10 #7445

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Fatboy,

I have had the same procedure done with no issues. The addition of stem cells may make even better, but would add a few thousand dollars to the cost. Dental insurance is usually capped at some level so I would think this additional step would be self pay. This phase one study was completed over 3 years ago. Is there anyone stepping up to the plate to take it further through the pipeline? Once again safety is not an issue and the cells work well.

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VU Amsterdam Bone Study Published 21 Jul 2016 09:52 #7446

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Dov,
I agree there would be additional costs. And those costs have to come down in order to move the science. However there are cases where multiple implants are done during one procedure. I would think that the assistance of stem cells could overcome the price issue when the overall surgery is in the tens of thousands. And of course there are those who have no issues with cost. More than we know of. Ask Bernie Sanders!

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VU Amsterdam Bone Study Published 26 Jul 2016 07:18 #7477

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For those who may not be aware, allogeneic stem cell enhanced bone allografts are already on the market by RTI Biologics. RTI uses technology of MAPCs licenced from Athersys. It is still a small market but growing. www.rtix.com/en_us/products/product-implant/map3-cellular-allogeneic-bone-graft

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VU Amsterdam Bone Study Published 26 Jul 2016 07:24 #7478

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Wall Street Titan wrote: For those who may not be aware, allogeneic stem cell enhanced bone allografts are already on the market by RTI Biologics. RTI uses technology of MAPCs licenced from Athersys. It is still a small market but growing. www.rtix.com/en_us/products/product-implant/map3-cellular-allogeneic-bone-graft


I presume that is one of these self-proclaimed 361 products? or did they go thru clinical trials?

Wonder what will happen to all that stuff after the new CBER rules come in force :whistle:

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VU Amsterdam Bone Study Published 26 Jul 2016 07:40 #7480

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I presume that is one of these self-proclaimed 361 products? or did they go thru clinical trials?


Yes they are and for good reason. The cells come from bone marrow and are used in bone repair. Both the bone chips and MAPCs come from the cadaver.

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VU Amsterdam Bone Study Published 26 Jul 2016 07:48 #7481

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Hot off the press


RTI Surgical® Continues to Advance Science Behind Allograft Implantation
Peer-Reviewed, Pre-Clinical Study Published in Journal of Tissue Engineering

July 25, 2016 04:35 PM Eastern Daylight Time
ALACHUA, Fla.--(BUSINESS WIRE)--RTI Surgical, Inc. (RTI) (Nasdaq: RTIX), a leading global surgical implant company, announced that a peer-reviewed, pre-clinical study titled Multipotent adult progenitor cells on an allograft scaffold facilitate the bone repair process has been published in the latest edition of the Journal of Tissue Engineering.

“We are proud of our advancements in the allograft industry and this study’s results that support the science behind our map3 implant.”

The pre-clinical study, conducted by Amanda LoGuidice, PhD., used similar materials to the proprietary, patented MAPC®-based technology used in RTI Surgical’s map3® Cellular Allogeneic Bone Grafts. The study is the first peer-reviewed, published pre-clinical study comparing multipotent adult progenitor cells (MAPCs) to mesenchymal stem cells (MSCs) in bone healing.

Results demonstrated MAPCs exhibited a more robust angiogenic protein release profile compared to MSCs in vitro. In addition, MAPCs demonstrated enhanced revascularization and new bone formation in vivo in an orthotopic defect model when compared to MSCs when placed on a DBM scaffold.

“We value research that helps us continue to provide surgeons with safe, high-quality implants,” said Carrie A. Hartill, executive vice president and chief scientific officer of RTI Surgical. “We are proud of our advancements in the allograft industry and this study’s results that support the science behind our map3 implant.”

The full study can be viewed here.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com .

MAPC® is a registered trademark of Athersys, Inc.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management's beliefs and certain assumptions made by our management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company's SEC filings may be obtained by contacting the company or the SEC or by visiting RTI's website at www.rtix.com or the SEC's website at www.sec.gov .

Contacts
RTI Surgical, Inc.
Wendy Crites Wacker, APR, 386-418-8888
Vice President, Global Communications

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VU Amsterdam Bone Study Published 26 Jul 2016 10:16 #7484

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Wall Street Titan wrote:

I presume that is one of these self-proclaimed 361 products? or did they go thru clinical trials?


Yes they are and for good reason. The cells come from bone marrow and are used in bone repair. Both the bone chips and MAPCs come from the cadaver.


To me - all things allo do not fall under the non-cultured self bone marrow exemption

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