Category Archives: Regenerative Medicine

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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.

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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

MELBOURNE, Australia, May 10, 2012 /PRNewswire/ -- Global regenerative medicine company Mesoblast Limited (MSB.AX) today announced the appointment of Dr Ben-Zion Weiner, Special Adviser to the CEO of Teva Pharmaceutical Industries Ltd, as a non-executive Director of Mesoblast, effective immediately.

Dr Weiner has been Teva's head of global research and development for over three decades, most recently as Chief R&D Officer and a member of the Teva Executive Committee. In this role, he has directly overseen all pharmaceutical R&D and innovative branded product pipeline development.

Dr Weiner has been responsible for the development of hundreds of generic products for the US, EU and other markets. In parallel, he has been responsible for the development and regulatory approval of Teva's innovative product portfolio. Dr Weiner has twice been the recipient of the Rothschild prize for innovation, including for the commercialization of Copaxone in the treatment of multiple sclerosis.

Dr Weiner said: "I am happy and proud to be a Board member of Mesoblast. I trust that stem cell technology is the future of medicine, and that Mesoblast is at the cutting edge of this exciting new field.

"I believe that Mesoblast's unique technology and professional execution capabilities have the potential to deliver multiple innovative biologic products across a broad range of clinical indications," added Dr Weiner.

Mesoblast Chairman, Mr Brian Jamieson, said: "Dr Weiner's extensive pharmaceutical industry experience and his current role as Special Adviser to the Teva CEO make him a very valuable and strategic addition to the Board. We also acknowledge the important contributions and insights provided by Teva's retiring board representative, Kevin Buchi, and wish him well.

"As Mesoblast expands its clinical product portfolio and approaches product commercialization, we will continue to broaden the mix of skills and international expertise of our Directors to ensure that the Board is in the best position to deliver maximal shareholder value."

About Mesoblast Mesoblast Limited (MSB.AX) is a world leader in commercialising biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). http://www.mesoblast.com

For further information, please contact: Julie Meldrum Corporate Communications Mesoblast Limited E: julie.meldrum@mesoblast.com

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New Teva Representative Joins Mesoblast Board of Directors

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South Korea's government is focused on boosting funds for stem-cell research this year.

Jo Yong Hak/Reuters

The South Korean health ministry announced last month that research into stem cells and regenerative medicine will receive a funding boost of 33 billion won (US$29 million) in 2012, four times that given in 2011. Overall, six different ministries will invest 100 billion won in stem-cell research this year.

Until last year, public investment in stem cells in South Korea was relatively low and targeted mainly at basic research. But the country's Ministry of Health and Welfare is now expanding its support for clinical research on stem cells, with the money being used to link basic research to intermediate or clinical studies. The aim is to commercialize the research at an early stage.

"From the current research atmosphere and infrastructure, the government has judged that stem-cell studies are now maturing," says Hyung Min Chung, president of Seoul-based biotechnology firm Cha Bio and Diostech and an adviser on the budget plan. He adds that his company is particularly pleased that government investment decisions on developing stem-cell therapies will be made more quickly.

The government money will be allocated to two areas: rare or incurable diseases for which there is little incentive for private investment, such as spinal cord damage; and common chronic conditions, such as arthritis, for which the aim is to help South Korean companies to capture part of the large potential market for treatments.

South Korea has been trying to restore its tarnished image in the field after the fall of one of its stellar stem-cell scientists, Woo Suk Hwang, who was convicted in 2009 for embezzlement and bioethics violations after falsifying results. The country has begun to regain confidence from a series of successful research projects, and is ranked in the world's top ten for stem-cell and regenerative medicine research in terms of number and quality of publications. The South Korean government thinks that the country can be a top global competitor if the field is given enough support.

In the past year, the South Korean Food and Drug Administration (FDA) has approved the worlds first three stem-cell treatments Hearticellgram-AMI, Cupistem and Cartistem which followed on the heels of clinical tests for human embryonic stem-cell therapies approved in 2010, according to the health ministry.

But many are still wary of those therapies. Clearly, there has been increased international focus on what is going on in the Korean regenerative industry since the approval of three stem-cell products in the past year, which I think caught many industry observers off guard, says Douglas Sipp, who works on stem-cell policy and ethics at the RIKEN Center for Developmental Biology in Kobe, Japan. "It appears that the Korean FDA has been focusing on fast-tracking products through the approval pathway, he says, adding that it will be interesting to see what other regulatory authorities think about these products.

Dong Wook Han, a professor of stem-cell biology at Konkuk University in Seoul, is worried about how the country regulates clinical research on stem cells. "Compared to a country like Germany, where I studied and where the regulations on embryonic stem cells are much stricter, South Korea has more freedom in regulation, which means it can explore more opportunities in clinical research. However, he emphasizes that instead of moving too quickly, South Korea needs to adopt the stricter regulations from other countries to test safety and efficacy.

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South Korea steps up stem-cell work

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the Companys three ongoing clinical trials, have recently authorized the Company to move forward with enrollment and treatment of additional patients with Stargardts disease (SMD). In the U.S. SMD trial, ACT will screen and enroll patients for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells - as compared with the 50,000 cell dose used in the patients of the first cohort. The Company has also been approved to treat the final two patients to round out the initial dosing arm in its European trial. The use of pluripotent stem cells to derive RPE cells, and the use of the resulting RPE cells for treating a wide range of macular degenerative disorders, are covered by a robust patent portfolio owned by ACT, including a number of issued broad patents in key world markets.

DSMB authorization to move to the next higher dosage of cells in our U.S. clinical trial and complete the treatment of the first cohort of patient in our European trial represents yet another significant advancement for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. We are pleased with the pace of progress and the continued finding of safety amongst the participants in both the U.S. and European trials. The results so far have been encouraging, and with our SMD programs having been granted orphan medicinal product designation in both the U.S. and Europe, we look forward to eventually reaching a stage at which we can further avail ourselves of all the regulatory and financial benefits this designation brings.

The three procedures comprising the first cohort of patients in the U.S. SMD trial were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. The first procedure in the E.U. trial was conducted at Moorfields Eye Hospital in London, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London.

We are gratified to be moving to the next stage in both of our SMD trials, commented Robert Lanza, M.D., ACTs chief scientific officer. We remain very encouraged by the preliminary data in the first four SMD patients treated with the lowest dose of RPE cells at UCLA and Moorfields Eye Hospital. We are doubling the number of cells that will be transplanted in the next group of patients in the U.S. trial. We will be anxious to see if the higher dosage of RPE cells will impact visual function and photoreceptor rescue.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. On January 20, 2012, the first SMD patient enrolled in the Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006, NCT01469832 and NCT01344993.

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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ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Increase RPE Dosage for Stargardt’s Disease Patients ...