Category Archives: Regenerative Medicine

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.

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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

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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

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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.

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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.

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Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London

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MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.

Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).

ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

About SMD, Dry AMD and Degenerative Diseases of the Retina

Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.

The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.

Juventas technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.

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CLI has become a very exciting clinical opportunity, Aras said. Its becoming a growing area of interest for a number of biotech and pharma companies.

Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.

Among the top advantages of Juventas CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the companys therapeutic in an easy procedure at a physician office, and the approach doesnt require bone marrow aspiration to obtain patients own stem cells or complex cell processing as some competing therapeutics do.

Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.

The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.

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Regenerative medicine company begins enrollment in critical limb ischemia trial

Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.

The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.

Juventas technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.

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CLI has become a very exciting clinical opportunity, Aras said. Its becoming a growing area of interest for a number of biotech and pharma companies.

Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.

Among the top advantages of Juventas CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the companys therapeutic in an easy procedure at a physician office, and the approach doesnt require bone marrow aspiration to obtain patients own stem cells or complex cell processing as some competing therapeutics do.

Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.

The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.

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Regenerative medicine company begins enrollment in critical limb ischemia trial