Stem Cell Articles - Page 504

manouli · 08-01-2012, 12:39 PM

Defects And Injuries To Head, Mouth May In Future With Treated By Stem Cell Therapy
Main Category: Dentistry
Also Included In: Stem Cell Research; Bones / Orthopedics
Article Date: 01 Aug 2012 - 0:00 PDT

In the first human study of its kind, researchers found that using stem cells to re-grow craniofacial tissues - mainly bone - proved quicker, more effective and less invasive than traditional bone regeneration treatments.

Researchers from the University of Michigan School of Dentistry and the Michigan Center for Oral Health Research partnered with Ann Arbor-based Aastrom Biosciences Inc. in the clinical trial, which involved 24 patients who required jawbone reconstruction after tooth removal

more...

http://www.medicalnewstoday.com/releases/248449.php

manouli · 08-04-2012, 02:12 PM

We don't want falls hope, deeply inside us we know if it's real therapy or phony one.

Fears over 'stem cell tourism'
Date
August 5, 2012

A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted

Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly.

The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month.

read...

http://www.smh.com.au/national/healt...804-23m9s.html

manouli · 08-05-2012, 12:00 PM

Aaron Curry of Raiders underwent stem-cell therapy
By Brian McIntyre NFL.com
Around the League writer
Published: Aug. 5, 2012 at 08:40 a.m.
Updated: Aug. 5, 2012 at 09:57 a.m.

By Brian McIntyre NFL.com

Oakland Raiders linebacker Aaron Curry remains on the "Active/PUP" list due to a pair of injured knees, but feels he's close to coming back after undergoing stem-cell therapy this offseason, Paul Gutierrez of CSN Bay Area reports.

It's the only thing that's helping me recover," Curry said on Saturday. "Without it, I'd be a lost cause. For sure."

Curry might not have lived up to his "best linebacker prospect in a decade" billing was coming out of Wake Forest and selected fourth overall by the Seattle Seahawks in the 2009 NFL Draft. In fact, some could have called Curry a "lost cause" during the final days of his tenure with the Seahawks, but he has been durable.

more...

http://www.nfl.com/news/story/0ap200...emcell-therapy

manouli · 08-06-2012, 06:35 PM

Brain's Stem Cells 'Eavesdrop' to Find out When to Act

ScienceDaily (Aug. 6, 2012) — Working with mice, Johns Hopkins researchers say they have figured out how stem cells found in a part of the brain responsible for learning, memory and mood regulation decide to remain dormant or create new brain cells. Apparently, the stem cells "listen in" on the chemical communication among nearby neurons to get an idea about what is stressing the system and when they need to act.

The researchers say understanding this process of chemical signaling may shed light on how the brain reacts to its environment and how current antidepressants work, because in animals these drugs have been shown to increase the number of brain cells. The findings are reported July 29 in the advance online publication of Nature.

"What we learned is that brain stem cells don't communicate in the official way that neurons do, through synapses or by directly signaling each other," says Hongjun Song, Ph.D., professor of neurology and director of Johns Hopkins Medicine's Institute for Cell Engineering's Stem Cell Program. "Synapses, like cell phones, allow nerve cells to talk with each other. Stem cells don't have synapses, but our experiments show they indirectly hear the neurons talking to each other; it's like listening to someone near you talking on a phone."

read...

http://www.sciencedaily.com/releases...806093934.htm?

manouli · 08-07-2012, 10:38 AM

press release

Aug. 7, 2012, 8:30 a.m. EDT

University Hospitals Case Medical Center to Study Stem Cell Therapy for Stroke Treatment
National study uses MultiStem® therapy developed by Athersys

CLEVELAND, Aug. 7, 2012 /PRNewswire via COMTEX/ -- A new national study looking at the safety and effectiveness of new medication developed from adult stem cells for the treatment of ischemic stroke has opened at University Hospitals (UH) Case Medical Center. The Phase 2 study will use a cell therapy product called MultiStem® developed by the Cleveland-based biotechnology company Athersys. Ischemic stroke is caused by blockage in an artery in or to the brain, that impedes blood flow, and that can result in serious disability or even death.

more....

http://www.marketwatch.com/story/uni...ent-2012-08-07

manouli · 08-07-2012, 05:47 PM

Quote:

Originally Posted by vothanhcam

thanks for share Stem Cell Articles

welcome to this site vothanhcam!

manouli.

ineedmyelin · 08-07-2012, 06:30 PM

Most all chronic sci will need to replace or rebuild atrophied muscles if and when a therapy that helps one walk again becomes available. Read the following article on trials being conducted by Pluristem.

Clinical Trial to Demonstrate Safety and Efficacy of PLX Cells for Regeneration of Injured Gluteal Muscle Following Total Hip Replacement

HAIFA, Israel, Aug. 7, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), the medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of its PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.

Muscle damage is a common result of hip replacement surgery, which is rising in incidence in Europe and other developed nations. The incidence of hip replacement surgery in the European Union is approximately 150 per every 100,000 people. On average, the number of hip replacement surgeries in the EU increased one-third between 1998 and 2008. The company believes that in the United States there are 300,000 total and partial hip replacements each year.

18 patients scheduled to undergo a total hip replacement will participate in this study. The subjects will randomize to one of three treatment arms, including two active-treatment arms and one placebo arm. On day one of the study, subjects will undergo total hip replacement surgery. Subjects will receive either PLX cells or placebo, through intramuscular injection, during the procedure. The expected total active duration of the study for each subject is 12 months.

"This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine," said Zami Aberman, Chairman and CEO of Pluristem. "We are very pleased with the growing number of new indications and new clinical trials currently initiated for our PLX cells around the world."

About Pluristem Therapeutics

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.

Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-RAD for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.

Pluristem has a strong patent portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, Follow Pluristem on Twitter@Pluristem, the content of which is not part of this press release.

http://www.nasdaq.com/article/pluris...20120807-00055

manouli · 08-07-2012, 07:09 PM

Quote:

Originally Posted by ineedmyelin

Most all chronic sci will need to replace or rebuild atrophied muscles if and when a therapy that helps one walk again becomes available. Read the following article on trials being conducted by Pluristem.

Clinical Trial to Demonstrate Safety and Efficacy of PLX Cells for Regeneration of Injured Gluteal Muscle Following Total Hip Replacement

HAIFA, Israel, Aug. 7, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), the medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of its PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement.

Muscle damage is a common result of hip replacement surgery, which is rising in incidence in Europe and other developed nations. The incidence of hip replacement surgery in the European Union is approximately 150 per every 100,000 people. On average, the number of hip replacement surgeries in the EU increased one-third between 1998 and 2008. The company believes that in the United States there are 300,000 total and partial hip replacements each year.

18 patients scheduled to undergo a total hip replacement will participate in this study. The subjects will randomize to one of three treatment arms, including two active-treatment arms and one placebo arm. On day one of the study, subjects will undergo total hip replacement surgery. Subjects will receive either PLX cells or placebo, through intramuscular injection, during the procedure. The expected total active duration of the study for each subject is 12 months.

"This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine," said Zami Aberman, Chairman and CEO of Pluristem. "We are very pleased with the growing number of new indications and new clinical trials currently initiated for our PLX cells around the world."

About Pluristem Therapeutics

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.

Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-RAD for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.

Pluristem has a strong patent portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, Follow Pluristem on Twitter@Pluristem, the content of which is not part of this press release.

http://www.nasdaq.com/article/pluris...20120807-00055

This is a good 1 article!

ineedmyelin · 08-07-2012, 07:12 PM

Here good info for those who battle chronic pressure sores/wounds.

GAITHERSBURG, MD — (MARKETWIRE) — 08/06/12 — Cytomedix, Inc. (CMXI:$1.61,00$0.35,0027.78%) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has issued a final National Coverage Determination (“NCD”) for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma (“PRP”) in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development (“CED”) program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes. In the final decision memo, CMS noted that it ” …has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment,” and concluded that, “when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS.” “We are extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. This determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel™ System, experience clinically significant health outcomes,” commented Martin P. Rosendale, Chief Executive Officer of Cytomedix (CMXI:$1.61,00$0.35,0027.78%) . “Importantly, we believe this decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for a favorable long-term arrangement in the U.S. wound care market, as clarity around the CED evidentiary requirements was a necessary element of the commercial market assessment,” added Mr. Rosendale. “In the meantime, our discussions for a distribution agreement to be executed prior to month’s end are progressing well.” Related to the evidentiary requirements, CMS outlined in the final decision memo that a research study that uses data collected by a registry can enhance its persuasiveness if it has the following attributes: It is a prospectively collected clinical research database for wound care that acquires certain standardized data elements. The information about the intervention is controlled and standardized, (i.e., the method of preparation of the PRP including the volume and concentration of platelets, lysate, anticoagulant or other additives, method and length of time of storage, centrifuge time, amount of blood taken for preparation, application schedule, etc.). There is longitudinal follow up whereby registry patients would have to be followed for pre-specified and well defined outcomes measured using standardized methods including: percentage of patients completely healed, time to healing, ulcer area reduction, durability of recovery, adverse events, and changes in functional status and mobility. There is a source of comparable patients who are treated with standard of care and for whom the data collection would have to be equivalent to that of the patients receiving PRP. Mr. Rosendale added, “This decision appears to indicate that our recent interactions with CMS have been productive, as CMS has acknowledged the rationale we presented for a comprehensive research study that can appropriately encompass practical study designs to meet the evidentiary requirements of CMS. We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program.” The complete final decision memo is available on the CMS website at: http://www.cms.gov/medicare-coverage...aspx?NCAId=260. About Coverage with Evidence Development Program CED is a process through which CMS provides conditional payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program. First introduced in 2005 and then refined in 2006, CED links Medicare coverage of specific promising technologies to a requirement that patients participate in a registry or clinical trial. Ultimately, the data generated is intended to be used as the basis for future coverage decisions once it is determined whether a treatment is reasonable and necessary. CED has also been referred to as a way to develop a “learning-based health care system” and the coverage to support it. About AutoloGel™ System The AutoloGel System utilizes a proprietary unique technology that enables rapid isolation and activation of PRP from a patient’s own blood. The PRP is subsequently processed to produce a gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be low and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors. The AutoloGel System is used at the point-of-care and is the only PRP system cleared by the U.S. Food and Drug Administration for use on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and for the management of mechanically or surgically-debrided wounds. Cytomedix’s (CMXI:$1.61,00$0.35,0027.78%) clinical studies have shown that AutoloGel rapidly and more effectively improved healing compared with control-treated wounds. This has been demonstrated in a variety of clinical studies including a systematic review of 21 comparison studies and a number of other observational and case series publications as well. About Cytomedix, Inc. (CMXI:$1.61,00$0.35,0027.78%) Cytomedix, Inc. (CMXI:$1.61,00$0.35,0027.78%) is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body’s natural healing processes. The Company’s advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company’s patient-derived PRP systems are marketed by Cytomedix (CMXI:$1.61,00$0.35,0027.78%) in the U.S. and distributed internationally. Our commercial products include the AutoloGel™ System, cleared by the FDA for wound care and the Angel® Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell (“ALDHbr”) technology to isolate a unique, biologically active population of a patient’s own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway.

http://investorstemcell.com/featured...ic-wound-care/

manouli · 08-08-2012, 09:53 AM

We want stem cell companies to make profit because they will continue their stem cell research.

International Stem Cell Corporation to Host Second Quarter 2012 Financial Results Conference Call at 11:00 am

CARLSBAD, CA — International Stem Cell Corporation (OTCQB: ISCO) www.internationalstemcell.com, a California-based biotechnology company focused on therapeutic and research products, announced today that it will host a conference call on Friday, August 10, 2012 at 11:00 am ET to discuss its financial results for the three months ended June 30, 2012.

Dr. Simon Craw, Executive Vice President of Business Development, and Ms. Linh Nguyen, Chief Financial Officer, will host the conference call.

To attend the call, please use the dial in information below:

read...

http://www.msnbc.msn.com/id/48567523

08-07-2012, 06:30 PM	#5037
ineedmyelin Senior Member Join Date: Dec 2004 Location: Central Texas Posts: 467	Pluristem Receives Approval to Commence a Phase I/II Study for Muscle Regeneration in Most all chronic sci will need to replace or rebuild atrophied muscles if and when a therapy that helps one walk again becomes available. Read the following article on trials being conducted by Pluristem. Clinical Trial to Demonstrate Safety and Efficacy of PLX Cells for Regeneration of Injured Gluteal Muscle Following Total Hip Replacement HAIFA, Israel, Aug. 7, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), the medical regulatory body in Germany, to commence a Phase I/II randomized, double blind, placebo controlled study to assess the safety and efficacy of its PLX cells, through intramuscular injections, for the regeneration of injured gluteal musculature following total hip replacement. Muscle damage is a common result of hip replacement surgery, which is rising in incidence in Europe and other developed nations. The incidence of hip replacement surgery in the European Union is approximately 150 per every 100,000 people. On average, the number of hip replacement surgeries in the EU increased one-third between 1998 and 2008. The company believes that in the United States there are 300,000 total and partial hip replacements each year. 18 patients scheduled to undergo a total hip replacement will participate in this study. The subjects will randomize to one of three treatment arms, including two active-treatment arms and one placebo arm. On day one of the study, subjects will undergo total hip replacement surgery. Subjects will receive either PLX cells or placebo, through intramuscular injection, during the procedure. The expected total active duration of the study for each subject is 12 months. "This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine," said Zami Aberman, Chairman and CEO of Pluristem. "We are very pleased with the growing number of new indications and new clinical trials currently initiated for our PLX cells around the world." About Pluristem Therapeutics Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route. Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-RAD for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis. Pluristem has a strong patent portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, Follow Pluristem on Twitter@Pluristem, the content of which is not part of this press release. http://www.nasdaq.com/article/pluris...20120807-00055 __________________ "And, in the end, the love you take is equal to the love you make."

08-07-2012, 07:12 PM	#5039
ineedmyelin Senior Member Join Date: Dec 2004 Location: Central Texas Posts: 467	Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care Here good info for those who battle chronic pressure sores/wounds. GAITHERSBURG, MD — (MARKETWIRE) — 08/06/12 — Cytomedix, Inc. (CMXI:$1.61,00$0.35,0027.78%) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has issued a final National Coverage Determination (“NCD”) for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma (“PRP”) in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development (“CED”) program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes. In the final decision memo, CMS noted that it ” …has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment,” and concluded that, “when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS.” “We are extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. This determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel™ System, experience clinically significant health outcomes,” commented Martin P. Rosendale, Chief Executive Officer of Cytomedix (CMXI:$1.61,00$0.35,0027.78%) . “Importantly, we believe this decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for a favorable long-term arrangement in the U.S. wound care market, as clarity around the CED evidentiary requirements was a necessary element of the commercial market assessment,” added Mr. Rosendale. “In the meantime, our discussions for a distribution agreement to be executed prior to month’s end are progressing well.” Related to the evidentiary requirements, CMS outlined in the final decision memo that a research study that uses data collected by a registry can enhance its persuasiveness if it has the following attributes: It is a prospectively collected clinical research database for wound care that acquires certain standardized data elements. The information about the intervention is controlled and standardized, (i.e., the method of preparation of the PRP including the volume and concentration of platelets, lysate, anticoagulant or other additives, method and length of time of storage, centrifuge time, amount of blood taken for preparation, application schedule, etc.). There is longitudinal follow up whereby registry patients would have to be followed for pre-specified and well defined outcomes measured using standardized methods including: percentage of patients completely healed, time to healing, ulcer area reduction, durability of recovery, adverse events, and changes in functional status and mobility. There is a source of comparable patients who are treated with standard of care and for whom the data collection would have to be equivalent to that of the patients receiving PRP. Mr. Rosendale added, “This decision appears to indicate that our recent interactions with CMS have been productive, as CMS has acknowledged the rationale we presented for a comprehensive research study that can appropriately encompass practical study designs to meet the evidentiary requirements of CMS. We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program.” The complete final decision memo is available on the CMS website at: http://www.cms.gov/medicare-coverage...aspx?NCAId=260. About Coverage with Evidence Development Program CED is a process through which CMS provides conditional payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program. First introduced in 2005 and then refined in 2006, CED links Medicare coverage of specific promising technologies to a requirement that patients participate in a registry or clinical trial. Ultimately, the data generated is intended to be used as the basis for future coverage decisions once it is determined whether a treatment is reasonable and necessary. CED has also been referred to as a way to develop a “learning-based health care system” and the coverage to support it. About AutoloGel™ System The AutoloGel System utilizes a proprietary unique technology that enables rapid isolation and activation of PRP from a patient’s own blood. The PRP is subsequently processed to produce a gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be low and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors. The AutoloGel System is used at the point-of-care and is the only PRP system cleared by the U.S. Food and Drug Administration for use on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and for the management of mechanically or surgically-debrided wounds. Cytomedix’s (CMXI:$1.61,00$0.35,0027.78%) clinical studies have shown that AutoloGel rapidly and more effectively improved healing compared with control-treated wounds. This has been demonstrated in a variety of clinical studies including a systematic review of 21 comparison studies and a number of other observational and case series publications as well. About Cytomedix, Inc. (CMXI:$1.61,00$0.35,0027.78%) Cytomedix, Inc. (CMXI:$1.61,00$0.35,0027.78%) is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body’s natural healing processes. The Company’s advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company’s patient-derived PRP systems are marketed by Cytomedix (CMXI:$1.61,00$0.35,0027.78%) in the U.S. and distributed internationally. Our commercial products include the AutoloGel™ System, cleared by the FDA for wound care and the Angel® Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell (“ALDHbr”) technology to isolate a unique, biologically active population of a patient’s own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. http://investorstemcell.com/featured...ic-wound-care/ __________________ "And, in the end, the love you take is equal to the love you make."

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08-01-2012, 12:39 PM	#5031
manouli Senior Member Join Date: Nov 2004 Location: florida Posts: 9,356	Defects And Injuries To Head, Mouth May In Future With Treated By Stem Cell Therapy Main Category: Dentistry Also Included In: Stem Cell Research; Bones / Orthopedics Article Date: 01 Aug 2012 - 0:00 PDT In the first human study of its kind, researchers found that using stem cells to re-grow craniofacial tissues - mainly bone - proved quicker, more effective and less invasive than traditional bone regeneration treatments. Researchers from the University of Michigan School of Dentistry and the Michigan Center for Oral Health Research partnered with Ann Arbor-based Aastrom Biosciences Inc. in the clinical trial, which involved 24 patients who required jawbone reconstruction after tooth removal more... http://www.medicalnewstoday.com/releases/248449.php

08-04-2012, 02:12 PM	#5032
manouli Senior Member Join Date: Nov 2004 Location: florida Posts: 9,356	We don't want falls hope, deeply inside us we know if it's real therapy or phony one. Fears over 'stem cell tourism' Date August 5, 2012 A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly. The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month. read... http://www.smh.com.au/national/healt...804-23m9s.html

08-05-2012, 12:00 PM	#5033
manouli Senior Member Join Date: Nov 2004 Location: florida Posts: 9,356	Aaron Curry of Raiders underwent stem-cell therapy By Brian McIntyre NFL.com Around the League writer Published: Aug. 5, 2012 at 08:40 a.m. Updated: Aug. 5, 2012 at 09:57 a.m. By Brian McIntyre NFL.com Oakland Raiders linebacker Aaron Curry remains on the "Active/PUP" list due to a pair of injured knees, but feels he's close to coming back after undergoing stem-cell therapy this offseason, Paul Gutierrez of CSN Bay Area reports. It's the only thing that's helping me recover," Curry said on Saturday. "Without it, I'd be a lost cause. For sure." Curry might not have lived up to his "best linebacker prospect in a decade" billing was coming out of Wake Forest and selected fourth overall by the Seattle Seahawks in the 2009 NFL Draft. In fact, some could have called Curry a "lost cause" during the final days of his tenure with the Seahawks, but he has been durable. more... http://www.nfl.com/news/story/0ap200...emcell-therapy

08-06-2012, 06:35 PM	#5034
manouli Senior Member Join Date: Nov 2004 Location: florida Posts: 9,356	Brain's Stem Cells 'Eavesdrop' to Find out When to Act ScienceDaily (Aug. 6, 2012) — Working with mice, Johns Hopkins researchers say they have figured out how stem cells found in a part of the brain responsible for learning, memory and mood regulation decide to remain dormant or create new brain cells. Apparently, the stem cells "listen in" on the chemical communication among nearby neurons to get an idea about what is stressing the system and when they need to act. The researchers say understanding this process of chemical signaling may shed light on how the brain reacts to its environment and how current antidepressants work, because in animals these drugs have been shown to increase the number of brain cells. The findings are reported July 29 in the advance online publication of Nature. "What we learned is that brain stem cells don't communicate in the official way that neurons do, through synapses or by directly signaling each other," says Hongjun Song, Ph.D., professor of neurology and director of Johns Hopkins Medicine's Institute for Cell Engineering's Stem Cell Program. "Synapses, like cell phones, allow nerve cells to talk with each other. Stem cells don't have synapses, but our experiments show they indirectly hear the neurons talking to each other; it's like listening to someone near you talking on a phone." read... http://www.sciencedaily.com/releases...806093934.htm?

08-07-2012, 10:38 AM	#5035
manouli Senior Member Join Date: Nov 2004 Location: florida Posts: 9,356	press release Aug. 7, 2012, 8:30 a.m. EDT University Hospitals Case Medical Center to Study Stem Cell Therapy for Stroke Treatment National study uses MultiStem® therapy developed by Athersys CLEVELAND, Aug. 7, 2012 /PRNewswire via COMTEX/ -- A new national study looking at the safety and effectiveness of new medication developed from adult stem cells for the treatment of ischemic stroke has opened at University Hospitals (UH) Case Medical Center. The Phase 2 study will use a cell therapy product called MultiStem® developed by the Cleveland-based biotechnology company Athersys. Ischemic stroke is caused by blockage in an artery in or to the brain, that impedes blood flow, and that can result in serious disability or even death. more.... http://www.marketwatch.com/story/uni...ent-2012-08-07

08-08-2012, 09:53 AM	#5040
manouli Senior Member Join Date: Nov 2004 Location: florida Posts: 9,356	We want stem cell companies to make profit because they will continue their stem cell research. International Stem Cell Corporation to Host Second Quarter 2012 Financial Results Conference Call at 11:00 am CARLSBAD, CA — International Stem Cell Corporation (OTCQB: ISCO) www.internationalstemcell.com, a California-based biotechnology company focused on therapeutic and research products, announced today that it will host a conference call on Friday, August 10, 2012 at 11:00 am ET to discuss its financial results for the three months ended June 30, 2012. Dr. Simon Craw, Executive Vice President of Business Development, and Ms. Linh Nguyen, Chief Financial Officer, will host the conference call. To attend the call, please use the dial in information below: read... http://www.msnbc.msn.com/id/48567523