Category Archives: Regenerative Medicine

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A short and sweet note to point you to a great article on bioreactor technologies related to cell therapy bioprocessing by CTG consultant and Director of Stem Cell-based Drug Discovery, John E. Hambor, who you can now follow on Twitter @StemCellonDrugs.


"Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing" was published in the June issue of BioProcess International.  


The BPI team has made a real and meaningful commitment to representing cell therapy bioprocessing and we applaud them for their contribution to this emerging discipline.




If this is a topic of interest to you, I recommend you also check out a conference being held this Fall by BPI's sister company, IBC LifeSciences, entitled "Cell Therapy BioProcessing" to be held September 11-12 in Arlington, Virginia.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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SAN DIEGO, CA--(Marketwire -06/06/12)-

Bio-Matrix Scientific Group (BMSN) (BMSN) announced today that its Regen BioPharma unit has appointed three internationally renowned regenerative medicine experts to its Scientific Advisory Board (SAB). The new SAB members appointed are David White, M.D., PhD; Wei-Ping Min, M.D., PhD and Vlad Bogin, M.D.

Dr. White is a member of the Surgery and Immunology faculty of The Schulic School of Medicine, University of Western Ontario. He is one of the leading experts on using regenerative medicine transplant procedures to treat pancreatic conditions, including diabetes. He is also the Chief Scientific Officer of Sernova Corp and was formerly a Therapeutic Area Head for Novartis. He received the B.Sc. degree from the University of Surrey and the M.D. and PhD degrees from Cambridge University.

Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.

Dr. Bogin is the President and CEO of Cromos Pharma, a contract research organization that specializes in biopharmaceutical clinical outsourcing. He was formerly the Director of Boehringer Ingelheim in charge of the phase IV program for Dabigatran Etexilate. He studied at the Yale University School of Medicine and the University of Rochester School of Medicine and Dentistry.

Regen BioPharma has also entered into a Letter of Intent with Clinartis LLC, a global contract research organization (CRO). Clinartis is a full service global CRO serving pharmaceutical, biotech and medical device companies to support Phase I - IV drug and device clinical trials in the US and Europe.

The SAB and Clinartis will assist the Company in its acquisition of intellectual property related to stem cells, translation of the intellectual property into treatments, and optimizing the value of these new therapies.

"The potential of regenerative medicine products is significant," says Christopher Mizer, the President of Regen BioPharma. "We believe that strategic collaborative relationships between Regen BioPharma, our SAB and Clinartis will facilitate our efforts to create value from that potential by developing proprietary, life sciences technologies and demonstrating their clinical utility."

"Our strong SAB has scientific and regulatory expertise, coupled with Clinartis' access to world-class researchers and investigators will be very instrumental for accelerated commercialization of the cutting-edge biotechnology research on which Regen BioPharma is focused," according to Bio-Matrix Scientific Group's Chairman & CEO David Koos.

About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:

The rest is here:
Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in ...

SAN DIEGO, CA--(Marketwire -06/06/12)-

Bio-Matrix Scientific Group (BMSN) (BMSN) announced today that its Regen BioPharma unit has appointed three internationally renowned regenerative medicine experts to its Scientific Advisory Board (SAB). The new SAB members appointed are David White, M.D., PhD; Wei-Ping Min, M.D., PhD and Vlad Bogin, M.D.

Dr. White is a member of the Surgery and Immunology faculty of The Schulic School of Medicine, University of Western Ontario. He is one of the leading experts on using regenerative medicine transplant procedures to treat pancreatic conditions, including diabetes. He is also the Chief Scientific Officer of Sernova Corp and was formerly a Therapeutic Area Head for Novartis. He received the B.Sc. degree from the University of Surrey and the M.D. and PhD degrees from Cambridge University.

Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.

Dr. Bogin is the President and CEO of Cromos Pharma, a contract research organization that specializes in biopharmaceutical clinical outsourcing. He was formerly the Director of Boehringer Ingelheim in charge of the phase IV program for Dabigatran Etexilate. He studied at the Yale University School of Medicine and the University of Rochester School of Medicine and Dentistry.

Regen BioPharma has also entered into a Letter of Intent with Clinartis LLC, a global contract research organization (CRO). Clinartis is a full service global CRO serving pharmaceutical, biotech and medical device companies to support Phase I - IV drug and device clinical trials in the US and Europe.

The SAB and Clinartis will assist the Company in its acquisition of intellectual property related to stem cells, translation of the intellectual property into treatments, and optimizing the value of these new therapies.

"The potential of regenerative medicine products is significant," says Christopher Mizer, the President of Regen BioPharma. "We believe that strategic collaborative relationships between Regen BioPharma, our SAB and Clinartis will facilitate our efforts to create value from that potential by developing proprietary, life sciences technologies and demonstrating their clinical utility."

"Our strong SAB has scientific and regulatory expertise, coupled with Clinartis' access to world-class researchers and investigators will be very instrumental for accelerated commercialization of the cutting-edge biotechnology research on which Regen BioPharma is focused," according to Bio-Matrix Scientific Group's Chairman & CEO David Koos.

About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:

See the original post here:
Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in ...

CLEARWATER, FL--(Marketwire -06/01/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine science sector, has made its Scientific and Medical Board of Advisors publications available on the company website, http://www.biostemus.com.

Chief Executive Officer Dwight Brunoehler stated, "The company is very proud of the many contributions its SAMBA members have made, and continue to make, to the medical community. As their publications and credentials show, this is a very prestigious and influential group. Having worked with them in past projects and now at Biostem, I know them all to be active participants in the development and guidance of the company's objectives. Their diversified areas of expertise and backgrounds are already playing a major role in assisting the company as it moves forward into the expanding field of regenerative medicine."

About Biostem U.S., Corporation Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S., Corporation is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group 310-974-6821.

Read more:
Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

But Reviewers Urge Caution in Development and Clinical Use of Adipose Stem Cells

Newswise Philadelphia, Pa. (May 29, 2012) Adipose stem cells (ASCs)stem cells derived from fatare a promising source of cells for use in plastic surgery and regenerative medicine, according to a special review in the June issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

But much more research is needed to establish the safety and effectiveness of any type of ASC therapy in human patients, according to the article by Dr. Rod Rohrich of University of Texas Southwestern Medical Center, Dallas, and colleagues. Dr. Rohrich is Editor-in-Chief of Plastic and Reconstructive Surgery.

Adipose Stem CellsExciting Possibilities, but Proceed with Caution The authors present an up-to-date review of research on the science and clinical uses of ASCs. Relatively easily derived from human fat, ASCs are "multipotent" cells that can be induced to develop into other kinds of cellsnot only fat cells, but also bone, cartilage and muscle cells.

Adipose stem cells promote the development of new blood vessels (angiogenesis) and seem to represent an "immune privileged" set of cells that blocks inflammation. "Clinicians and patients alike have high expectations that ASCs may well be the answer to curing many recalcitrant diseases or to reconstruct anatomical defects," according to Dr. Rohrich and coauthors.

However, even as the number of studies using ASCs increases, there is continued concern about their "true clinical potential." The reviewers write, "For example, there are questions related to isolation and purification of ASCs, their effect on tumor growth, and the enforcement of FDA regulations."

Dr. Rohrich and coauthors performed an in-depth review to identify all known clinical trials of ASCs. So far, most studies have been performed in Europe and Korea; reflecting stringent FDA regulations, only three ASC studies have been performed in the United States to date.

Many Different Uses, But Little Experience So Far Most ASC clinical trials to date have been performed in plastic surgerya field with "unique privileged access to adipose tissues." Plastic surgeon-researchers have used ASCs for several types of soft tissue augmentation, such as breast augmentation (including after implant removal) and regeneration of fat in patients with abnormal fat loss (lipodystrophy). Studies exploring the use of ASCs to promote healing of difficult wounds have been reported as well. They have also been used as a method of soft tissue engineering or tissue regeneration, with inconclusive results.

In other specialties, ASCs have been studied for use in treating certain blood and immunologic disorders, heart and vascular problems, and fistulas. Some studies have explored the use of ASCs for generating new bone for use in reconstructive surgery. A few studies have reported promising preliminary results in the treatment of diabetes, multiple sclerosis, and spinal cord injury. No serious adverse events related to ASCs were reported in either group of studies.

Although many of the results are encouraging, the reviewers emphasize that all of these applications are in their infancy. Around the world, for all uses, less than 300 patients have been treatedwith no standard protocol for the preparation or clinical applications of ASCs.

See the rest here:
Fat-Derived Stem Cells Show Promise for Regenerative Medicine, Says Review in Plastic and Reconstructive Surgery(r)

ARLINGTON HEIGHTS, Ill., May 29, 2012 (GLOBE NEWSWIRE) -- Adipose stem cells (ACSs)--stem cells derived from fat--are a promising source of cells for use in plastic surgery and regenerative medicine, according to a special review in the June issue of Plastic and Reconstructive Surgery(R), the official medical journal of the American Society of Plastic Surgeons (ASPS).

But much more research is needed to establish the safety and effectiveness of any type of ASC therapy in human patients, according to the article by ASPS Member Surgeon Rod Rohrich, MD of University of Texas Southwestern Medical Center, Dallas, and colleagues. Dr. Rohrich is Editor-in-Chief of Plastic and Reconstructive Surgery.

Adipose Stem Cells--Exciting Possibilities, but Proceed with Caution

The authors present an up-to-date review of research on the science and clinical uses of ASCs. Relatively easily derived from human fat, ASCs are "multipotent" cells that can be induced to develop into other kinds of cells--not only fat cells, but also bone, cartilage and muscle cells.

Adipose stem cells promote the development of new blood vessels (angiogenesis) and seem to represent an "immune privileged" set of cells that blocks inflammation. "Clinicians and patients alike have high expectations that ASCs may well be the answer to curing many recalcitrant diseases or to reconstruct anatomical defects," according to Dr. Rohrich and co-authors.

However, even as the number of studies using ASCs increases, there is continued concern about their "true clinical potential." The reviewers write, "For example, there are questions related to isolation and purification of ASCs, their effect on tumor growth, and the enforcement of FDA regulations."

Dr. Rohrich and co-authors performed an in-depth review to identify all known clinical trials of ASCs. So far, most studies have been performed in Europe and Korea; reflecting stringent FDA regulations, only three ASC studies have been performed in the United States to date.

Many Different Uses, But Little Experience So Far

Most ASC clinical trials to date have been performed in plastic surgery--a field with "unique privileged access to adipose tissues." Plastic surgeon-researchers have used ASCs for several types of soft tissue augmentation, such as breast augmentation (including after implant removal) and regeneration of fat in patients with abnormal fat loss (lipodystrophy). Studies exploring the use of ASCs to promote healing of difficult wounds have been reported as well. They have also been used as a method of soft tissue engineering or tissue regeneration, with inconclusive results.

In other specialties, ASCs have been studied for use in treating certain blood and immunologic disorders, heart and vascular problems, and fistulas. Some studies have explored the use of ASCs for generating new bone for use in reconstructive surgery. A few studies have reported promising preliminary results in the treatment of diabetes, multiple sclerosis, and spinal cord injury. No serious adverse events related to ASCs were reported in either group of studies.

More here:
Fat-Derived Stem Cells Show Promise for Regenerative Medicine, Says Review in Plastic and Reconstructive Surgery(R)

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Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

• Baxter Therapeutics' Auto-CD34+ cells
• phase III trial actively recruiting
• Indication:  refractory angina and chronic myocardial ischemia
• Estimated enrollment:  444
• Estimated primary completion: June 2016 
• Cytori
• phase II/III trial actively recruiting
• Indication: ST-elevation acute myocardial infarction
• Estimated enrollment: 360
• Estimated primary completion: July 2014

• Miltenyi Biotec
• phase III trial actively recruiting
• Indication: myocardial ischemia or coronary artery disease
• Estimated enrollment: 142
• Estimated primary completion: July 2012

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Tweet


Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.


The data to-date are admittedly confusing.  From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.


Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc. 


All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not.  We will not attempt to do so.


All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions.  So here it is:


Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication.  Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI).  The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.


Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials.  Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.

• Baxter Therapeutics' Auto-CD34+ cells
• phase III trial actively recruiting
• Indication:  refractory angina and chronic myocardial ischemia
• Estimated enrollment:  444
• Estimated primary completion: June 2016 
• Cytori
• phase II/III trial actively recruiting
• Indication: ST-elevation acute myocardial infarction
• Estimated enrollment: 360
• Estimated primary completion: July 2014

• Miltenyi Biotec
• phase III trial actively recruiting
• Indication: myocardial ischemia or coronary artery disease
• Estimated enrollment: 142
• Estimated primary completion: July 2012

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

22-05-2012 16:27 Introduced by CNBC anchor Larry Kudlow, science and medicine reporter Mike Huckman conducts an interview with Dr. Michael West, founder of Geron and CEO of BioTime, about the prospects for the regenerative medicine field and stem cell research under President Obama, shortly after Obama's inauguration.

Go here to see the original:
CNBC interview on prospects for regenerative medicine under Obama administration - Video

ROCKVILLE, Md., May 21, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that Richard Garr, CEO and President, will present at the World Stem Cells & Regenerative Medicine Congress in London (http://www.terrapinn.com/2012/stemcells/index.stm) on Tuesday, May 22nd at 12:30 PM. Mr. Garr's presentation, "Stem Cell Applications for Neurodegenerative Disorders," will review Neuralstem's cellular therapy trial in ALS, its neurogenic small molecule trial in major depressive disorder (MDD), and provide an overview on plans to expand the cellular therapy program.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

For more information, please visit http://www.neuralstem.com or connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2011 and the Form 10-Q for the period ended March 30, 2012.

Read more from the original source:
Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London