Stem Cell Clinic

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

By Uncategorized

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.

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The fat stopper: Protein that regulates the creation of fat cells identified

By Stem Cell Treatment

ScienceDaily (Apr. 23, 2012) Biological sciences major Adam Reese may have found the key to keep fat cells from forming.

The University of Delaware junior believes he has identified the trigger that turns a stem cell into a fat cell. Located on the surface of cells, the trigger -- a protein called endoglin -- regulates what type of cell an existing stem cell will become.

Working in the UD Department of Biological Sciences' laboratory of cellular signaling and dynamics with assistant professor Anja Nohe, Reese investigates ways to combat osteoporosis. His findings may also have implications for obesity.

Patients afflicted with osteoporosis lose bone mass as they age. Bone is a dynamic tissue, constantly renewed by removal or reabsorption of old bone and formation of new bone. Through this cellular remodeling process, roughly one-fifth of an adult's skeleton is replaced each year. Of the limited treatments developed to reduce bone loss, most have potentially serious side effects, are cost prohibitive, or are difficult to use.

Reese, with the help of graduate student Joyita Dutta, found that the amount of endoglin on a cell's surface indicates whether the cell will become a fat cell or a bone cell.

"What would happen if you could make the cell stop making the protein?" Reese said. "You could affect whether or not it's even a fat cell."

If the amount of endoglin on the cell surface could be decreased, the amount of cells turning into bone would rise, leading to an increase in bone strength, thus ending osteoporosis.

"I didn't really expect it. I expected the data would be the other way around," said Nohe, Reese's undergraduate research adviser. "It's very exciting."

According to Nohe, researchers did not previously know if endoglin was the key controlling the cells' change or if it was just a marker. She believes Reese's data shows endoglin is the driver, and pinpointing that could lead to a cure.

"Now we have a target that we could hit," she said.

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The fat stopper: Protein that regulates the creation of fat cells identified

Regenerative Medicine Institute, Mexico Presents Summary of Clinical Data at the International Society of Stem Cell …

By Stem Cell Treatment

TIJUANA, Mexico, April 23, 2012 (GLOBE NEWSWIRE) -- Regenerative Medicine Institute, Mexico (RMI) will be among top scientists and physicians presenting cutting edge data at the International Society of Stem Cell Research (ISSCR). The ISSCR's annual meeting has become the world's premier stem cell research event. The meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. The ISSCR 10th Annual Meeting will be held June 13 - 16, 2012 at the Pacifico Yokohama in Yokohama, Japan.

A summary of data on the use of adult stem cells from adipose tissue to treat heart failure and COPD will be presented by Kristin Comella, Chief Scientific Officer of Bioheart Inc. Bioheart is focused on the discovery, development, and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. RMI is currently running Phase I/II trials at the Hospital Angeles in collaboration with Bioheart and the Ageless Regenerative Institute.

Dr. Javier Lopez, President and CEO of RMI and a member of ISSCR said that "We are proud to share our initial results with the scientific community at such a prestigious event."

For more information on RMI, visit http://www.regenerativemedicine.mx

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Regenerative Medicine Institute, Mexico Presents Summary of Clinical Data at the International Society of Stem Cell ...

Starr Foundation Continues Support for Stem Cell Research in New York with $50 Million Gift

By Stem Cell Treatment

Tri-Institutional Stem Cell Initiative Pursues Cutting-Edge Stem Cell Research and Therapies

Newswise NEW YORK (April 23, 2012) -- The Starr Foundation is continuing its historic commitment to stem cell research with a $50 million gift in support of the Tri-Institutional Stem Cell Initiative (Tri-SCI), which was established through a generous grant from the Foundation in 2005. The new gift, awarded to the original Tri-SCI members -- Memorial Sloan-Kettering Cancer Center, The Rockefeller University and Weill Cornell Medical College, all in New York City -- will support and enhance collaborative, pioneering stem cell research at the three adjacent Manhattan campuses.

With support from The Starr Foundation, Tri-SCI laboratories are investigating the properties of embryonic stem cells, which have the potential to differentiate into any cell type in the body, and adult stem cells, which are found in various tissues and can give rise to specific cell types. These studies are opening new avenues for understanding a range of health conditions, including developmental disorders, neurodegenerative diseases and cancer. The knowledge gained through this research is also laying the groundwork for the design of regenerative therapies to replenish tissues lost to illness or injury.

Under the Tri-Institutional Stem Cell Initiative, investigators work across institutional and disciplinary boundaries to advance scientific understanding in a rapidly expanding field of biomedicine. The Tri-SCI funds technology development, seminars and symposia to foster intellectual exchange, and fellowships to train future leaders in stem cell research.

"Stem cell research has undergone a remarkable expansion and transformation in the seven years since this initiative was launched," says Maurice R. Greenberg, chairman of The Starr Foundation's Board of Directors. "There are many exciting developments on the horizon, and I am delighted that The Starr Foundation can renew its support of this important collaborative effort at such a promising time."

Based in New York City, the Foundation has long supported medical research, health care, human needs and educational programs in New York City, as well as cultural institutions and public policy projects relating to international relations. Of the nearly three billion dollars in grants made by the Foundation since 1955, more than half has gone to New York-based institutions.

"The goals of the Tri-Institutional Stem Cell Initiative are truly ambitious, and only a collaborative venture of this magnitude could provide the resources and expertise needed to achieve them," said Craig Thompson, MD, President and CEO of Memorial Sloan-Kettering Cancer Center. "All of us at Memorial Sloan-Kettering are deeply grateful to The Starr Foundation for its incredible vision and generosity in supporting this vital area of research."

"We deeply appreciate The Starr Foundation's generosity and commitment to excellence in biomedical research. The Tri-Institutional Stem Cell Initiative will enable our scientists to continue their pursuit of bold new ideas that will better human health," says Dr. Laurie H. Glimcher, the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College.

"To realize the full promise of stem cells in regenerative medicine, we need to understand the molecular mechanisms that determine a stem cell's potential to develop into many types of functional cells in the body," says Dr. Marc Tessier-Lavigne, president of The Rockefeller University. "As the climate for federal funding of stem cell research remains uncertain, we are grateful to The Starr Foundation for its continued commitment to supporting both existing and exciting new collaborative efforts by stem cell researchers at our three institutions."

Research Highlights from the Tri-Institutional Stem Cell Initiative

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Starr Foundation Continues Support for Stem Cell Research in New York with $50 Million Gift

Finding stem cell donor match warden’s ‘only hope’ for fighting cancer

By Stem Cell Treatment

If all goes according to plan in Gregory Sanborns life over the coming weeks, doctors find a matching stem cell donor for him and he undergoes an aggressive year of procedures and solitary recovery, he can return to work cancer-free.

I let my immune system get strong, I come back to work a year from now, and I live to be old, fat and happy in my garden, Sanborn said.

The alternative: a stem cell match is not found or a matching donation fails to produce the desired results. In that case, Sanborn knows what happens.

The cutaneous T-cell lymphoma that is ravaging his body wins.

And Sanborn dies.

Basically, its my only hope, Sanborn said of the stem-cell transplant he has been left to hope for. If it works, Ill be cured. And if it doesnt, I wont be.

Sanborn, a 46-year-old career game warden who now serves as the deputy chief of the Maine Warden Service, remains optimistic. He is also realistic. And after several months of treatment, Sanborn has learned that his self-reliance always one of his attributes of which he was proudest may stand in the way of his recovery.

Thats why last Friday he was willing to say something he never thought hed say.

As people come up to me now, I look right at them and say, You know what? At this point, Ill take whatever help anyone is willing to give me, because I truly cannot do this alone, Sanborn said.

Sanborn wont have to fight the battle alone. His brother wardens have joined forces with the University of Maine football team to hold a stem cell donor drive on Wednesday. The wardens hope to find a matching donor for Sanborn; the drive itself could benefit patients around the world, as the results will be added to a database that serves those in need of a transplant.

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Finding stem cell donor match warden’s ‘only hope’ for fighting cancer

"Housekeeping" Mechanism for Brain Stem Cells Discovered

By Stem Cell Medical Center

Findings offer new insights into neurologic development and regenerative therapies for neurologic disease

Newswise (New York, NY, April 22, 2012) Researchers at Columbia University Medical Center (CUMC) have identified a molecular pathway that controls the retention and release of the brains stem cells. The discovery offers new insights into normal and abnormal neurologic development and could eventually lead to regenerative therapies for neurologic disease and injury. The findings, from a collaborative effort of the laboratories of Drs. Anna Lasorella and Antonio Iavarone, were published today in the online edition of Nature Cell Biology.

The research builds on recent studies, which showed that stem cells reside in specialized niches, or microenvironments, that support and maintain them.

From this research, we knew that when stem cells detach from their niche, they lose their identity as stem cells and begin to differentiate into specific cell types, said co-senior author Antonio Iavarone, MD, professor of Pathology and Neurology at CUMC.

However, the pathways that regulate the interaction of stem cells with their niche were obscure, said co-senior author Anna Lasorella, MD, associate professor of Pathology and Pediatrics at CUMC and a member of the Columbia Stem Cell Initiative.

In the brain, the stem cell niche is located in an area adjacent to the ventricles, the fluid-filled spaces within the brain. Neural stem cells (NSCs) within the niche are carefully regulated, so that enough cells are released to populate specific brain areas, while a sufficient supply is kept in reserve.

In previous studies, Drs. Iavarone and Lasorella focused on molecules called Id (inhibitor of differentiation) proteins, which regulate various stem cell properties. They undertook the present study to determine how Id proteins maintain stem cell identity.

The team developed a genetically altered strain of mice in which Id proteins were silenced, or knocked down, in NSCs. In the absence of Id proteins, mice died within 24 hours of birth. Their brains showed markedly lowered NSC proliferative capacity, and their stem cell populations were reduced.

Studies of NSCs from this strain of mice revealed that Id proteins directly regulate the production of a protein called Rap1GAP, which in turn controls Rap1, one of the master regulators of cell adhesion. The researchers found that the Id-Rap1GAP-Rap1 pathway is critical for the adhesion of NSCs to their niche and for NSC maintenance. There may be other pathways involved, but we believe this is the key pathway, said Dr. Iavarone. There is good reason to believe that it operates in other kinds of stem cells, and our labs are investigating this question now.

This is a new idea, added Dr. Lasorella. Before this study, the prevailing wisdom was that NSCs are regulated by the niche components, conceivably through the release of chemical attractants such as cytokines. However, our findings suggest that stem cell identity relies on this mechanism.

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"Housekeeping" Mechanism for Brain Stem Cells Discovered

Former Alabama football players get stem cell injections from Gulf Shores doctor

By Stem Cell Clinic

MOBILE, Alabama -- At the end of this past season with the Oakland Raiders, an aching Rolando McClain gave an assignment to his agent: Find out more about stem cell therapies for injuries, like other athletes are trying.

Ive been having two seasons of nagging pain in my knee, the former University of Alabama standout said.

Not long afterward, McClain was on his way to Gulf Shores.

There, radiologist Jason R. Williams performed liposuction on McClain and then injected stem cells from the linebackers own fat cells into his knee and into the area of a high ankle sprain.

It feels a lot better, McClain said in an interview last week, adding that hes working out four days a week with the Raiders, running, lifting weights, doing squats and even sprinting with hardly any pain at all.

About three months ago, Williams, 38, began the new procedure in which he injects patients -- two of them being McClain and former University of Alabama receiver Marquis Maze -- with their own stem cells in an effort to repair damaged joints and muscles.

This is going to be the future of medicine, said Williams, who owns Precision StemCell, which includes a diagnostic and interventional radiology practice in Gulf Shores.

Stem cells, sometimes called the bodys master cells, are precursor cells that develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use.

Their promise in medicine, according to many scientists and doctors, is that the cells have the potential to help and regenerate other cells.

While Williams treatments are considered investigational, he said, they meet FDA guidelines since the stem cells are collected from a patients fat tissue and administered back to that patient during the same procedure.

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Former Alabama football players get stem cell injections from Gulf Shores doctor

Pitcher hopes stem cell procedure will get him one last season

By Stem Cell Doctors

When pitching in the Dominican Republic, C.J. Nitkowski said he felt he was back to his normal self on the mound

STORY HIGHLIGHTS

For the full story on C.J. Nitkowski's risky medical procedure and baseball comeback, watch CNN Presents, Sunday night at 8ET.

Alpharetta, Georgia (CNN) -- At 39 years old, Christopher John Nitkowski really has no business trying to pitch in the major leagues. In the harsh reality of professional sports, he's a has-been.

Just don't tell him that.

The former first-round draft pick last pitched for the Washington Nationals in 2005 after a 10-season career spent mostly as a left-handed reliever.

"You go as long as you can," he told CNN. "I had a good friend tell me, 'Man, just make them tear the uniform off of you. You can do whatever you're gonna do for the rest of your life. You can't play baseball forever.'"

A doctor injects C.J. Nitkowski's stem cells into his injured shoulder

In the middle of the 2011 baseball season Nitkowski announced in a first-person article for Sports Illustrated that he would try a comeback. After his brief major league appearance in 2005, he pitched subsequent years for one team in Japan and three in South Korea.

This time, he wrote, he would agree to a risky medical experiment that would involve injecting his own stem cells into his injured pitching shoulder, which he hurt in an initial comeback attempt last spring.

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Pitcher hopes stem cell procedure will get him one last season

New stem cell found in the brain

By Uncategorized

Public release date: 19-Apr-2012 [ | E-mail | Share ]

Contact: Tim Hawkins Tim.Hawkins@vai.org 616-234-5519 Van Andel Research Institute

Grand Rapids, Mich. (April 19, 2012 ) Researchers at Lund University in Sweden have discovered a new stem cell in the adult brain. These cells can proliferate and form several different cell types - most importantly, they can form new brain cells. Scientists hope to take advantage of the finding to develop methods to heal and repair disease and injury in the brain.

Analyzing brain tissue from biopsies, the researchers for the first time found stem cells located around small blood vessels in the brain. The cell's specific function is still unclear, but its plastic properties suggest great potential.

"A similar cell type has been identified in several other organs where it can promote regeneration of muscle, bone, cartilage and adipose tissue," said Patrik Brundin, M.D., Ph.D., Jay Van Andel Endowed Chair in Parkinson's Research at Van Andel Research Institute (VARI), Head of the Neuronal Survival Unit at Lund University and senior author of the study.

In other organs, researchers have shown clear evidence that these types of cells contribute to repair and wound healing. Scientists suggest that the curative properties may also apply to the brain. The next step is to try to control and enhance stem cell self-healing properties with the aim of carrying out targeted therapies to a specific area of the brain.

"Our findings show that the cell capacity is much larger than we originally thought, and that these cells are very versatile," said Gesine Paul-Visse, Ph.D., Associate Professor of Neuroscience at Lund University and the study's primary author. "Most interesting is their ability to form neuronal cells, but they can also be developed for other cell types. The results contribute to better understanding of how brain cell plasticity works and opens up new opportunities to exploit these very features."

The study, published in the journal PLoS ONE, is of interest to a broad spectrum of brain research. Future possible therapeutic targets range from neurodegenerative diseases to stroke.

"We hope that our findings may lead to a new and better understanding of the brain's own repair mechanisms," said Dr. Paul-Visse. "Ultimately the goal is to strengthen these mechanisms and develop new treatments that can repair the diseased brain."

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New stem cell found in the brain

ACT Announces Third Dry AMD Patient Treated in Clinical Trial

By Uncategorized

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The outpatient transplantation surgery was performed successfully, and the patient is recovering uneventfully.

Gary Rabin, chairman and CEO of ACT, commented, The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.

The procedures at UCLA were all conducted by the team led 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 six patients treated at UCLA to date have tolerated the surgical procedure well. commented Dr. Schwartz. There have been no complications in the procedure, nor any issues relating to the safety of the injected stem cell-derived RPE cells in any of the patients. We continue to regularly evaluate all patients in the trial, and while still preliminary, I am encouraged by the patients progress and the relative straightforwardness of the surgical procedure.

We are extremely pleased with the progress being made in all three of our clinical trials here in the U.S. and the U.K., commented Robert Lanza, M.D., ACTs chief scientific officer. The data we are reviewing seems to be pointing in the appropriate direction, With the treatment of the latest two dry AMD patients, we look forward to having more significant points of reference to understand the progress of the trial and consider the endpoint design for the next phase. Both Stargardts disease and dry AMD are progressive diseases that result vision loss and blindness due to the thinning of the layer of RPE cells in the patient's macula, the central portion of the retina responsible for central vision. We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration. We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.

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. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be 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.

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ACT Announces Third Dry AMD Patient Treated in Clinical Trial

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