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Second UM Stem Cell Line Now Available To Help Cure Nerve Condition

Posted: April 25, 2012 at 10:13 pm

ANN ARBOR The University of Michigans second human embryonic stem cell line has just been placed on the U.S. National Institutes of Healths registry, making the cells available for federally funded research. It is the second of the stem cell lines derived at UM to be placed on the registry.

The line, known as UM11-1PGD, was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. That embryo was created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation, and would therefore have otherwise been discarded when it was donated in 2011.

It carries the gene defect responsible for Charcot-Marie-Tooth disease, a hereditary neurological disorder characterized by a slowly progressive degeneration of the muscles in the foot, lower leg and hand. CMT, as it is known, is one of the most common inherited neurological disorders, affecting one in 2,500 people in the United States. People with CMT usually begin to experience symptoms in adolescence or early adulthood.

The embryo used to create the cell line was never frozen, but rather was transported from another IVF laboratory in the state of Michigan to the UM in a special container. This may mean that these stem cells will have unique characteristics and utilities in understanding CMT disease progression or screening therapies in comparison to other human embryonic stem cells.

We are proud to provide this cell line to the scientific community, in hopes that it may aid the search for new treatments and even a cure for CMT, says Gary Smith, Ph.D., who derived the line and also is co-director of the UM Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute. Once again, the acceptance of these cells to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines.

UM is one of only four institutions including two other universities and one private company to have disease-specific stem cell lines listed in the national registry. UM has several other disease-specific hESClines submitted to NIH and awaiting approval, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

Stem cell lines that carry genetic traits linked to specific diseases are a model system to investigate what causes these diseases and come up with treatments, says Sue OShea, professor of cell and developmental biology at the UM Medical School, and co-director of the Consortium for Stem Cell Therapies.

Each line is the culmination of years of preparation and cooperation between UM and Genesis Genetics, a Michigan-based genetic diagnostic company. This work was made possible by Michigan voters November 2008 approval of a state constitutional amendment permitting scientists to derive embryonic stem cell lines using surplus embryos from fertility clinics or embryos with genetic abnormalities and not suitable for implantation.

The amendment also made possible an unusual collaboration that has blossomed between the University of Michigan and molecular research scientists at Genesis Genetics, a company that has grown in only eight years to become the leading global provider of pre-implantation genetic diagnosis (PGD) testing. PGDis a testing method used to identify days-old embryos carrying the genetic mutations responsible for serious inherited diseases. During a PGD test, a single cell is removed from an eight-celled embryo. The other seven cells continue to multiply and on the fifth day form a cluster of roughly 100 cells known as a blastocyst.

Genesis Genetics performs nearly 7,500 PGD tests annually. Under the arrangement between the company and UM, patients with embryos that test positive for a genetic disease now have the option of donating those embryos to UM if they have decided not to use them for reproductive purposes and the embryos would otherwise be discarded.

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Second UM Stem Cell Line Now Available To Help Cure Nerve Condition

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New embryonic stem cell line will aid research on nerve condition

Posted: April 25, 2012 at 10:13 pm

Public release date: 25-Apr-2012 [ | E-mail | Share ]

Contact: Kara Gavin kegavin@umich.edu 734-764-2220 University of Michigan Health System

The University of Michigan's second human embryonic stem cell line has just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research. It is the second of the stem cell lines derived at U-M to be placed on the registry.

The line, known as UM11-1PGD, was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. That embryo was created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation, and would therefore have otherwise been discarded when it was donated in 2011.

It carries the gene defect responsible for Charcot-Marie-Tooth disease, a hereditary neurological disorder characterized by a slowly progressive degeneration of the muscles in the foot, lower leg and hand. CMT, as it is known, is one of the most common inherited neurological disorders, affecting one in 2,500 people in the United States. People with CMT usually begin to experience symptoms in adolescence or early adulthood.

The embryo used to create the cell line was never frozen, but rather was transported from another IVF laboratory in the state of Michigan to the U-M in a special container. This may mean that these stem cells will have unique characteristics and utilities in understanding CMT disease progression or screening therapies in comparison to other human embryonic stem cells.

"We are proud to provide this cell line to the scientific community, in hopes that it may aid the search for new treatments and even a cure for CMT," says Gary Smith, Ph.D., who derived the line and also is co-director of the U-M Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute. "Once again, the acceptance of these cells to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines."

U-M is one of only four institutions including two other universities and one private company to have disease-specific stem cell lines listed in the national registry. U-M has several other disease-specific hESC lines submitted to NIH and awaiting approval, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

"Stem cell lines that carry genetic traits linked to specific diseases are a model system to investigate what causes these diseases and come up with treatments," says Sue O'Shea, Ph.D., professor of Cell and Developmental Biology at the U-M Medical School, and co-director of the Consortium for Stem Cell Therapies.

Each line is the culmination of years of preparation and cooperation between U-M and Genesis Genetics, a Michigan-based genetic diagnostic company. This work was made possible by Michigan voters' November 2008 approval of a state constitutional amendment permitting scientists to derive embryonic stem cell lines using surplus embryos from fertility clinics or embryos with genetic abnormalities and not suitable for implantation.

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New embryonic stem cell line will aid research on nerve condition

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BioTime’s Subsidiary Cell Cure Neurosciences, Ltd. Provides Update on OpRegen® Product Development

Posted: April 23, 2012 at 9:13 pm

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex: BTX) announced today that Charles S. Irving, Ph.D., the CEO of BioTimes subsidiary Cell Cure Neurosciences, Ltd. will provide an update on the development of OpRegen at an investor meeting in New York City. In his presentation, Dr. Irving will describe the unmet medical needs and markets for the treatment of the dry form of age-related macular degeneration (AMD), and the advantages of Cell Cures OpRegen which has been produced from human embryonic stem cells in culture conditions free of animal products, eliminating the need for designating the product as a xenotransplantation therapeutic. Dr. Irving will also discuss Cell Cures collaboration with Teva Pharmaceutical Industries Ltd., under which Teva has the option to develop and commercialize both OpRegen and OpRegen-Plus. Dr. Irving will describe the nature of the ongoing preclinical studies which are expected to lead to regulatory filings for the initiation of human clinical trials in 2013. Dr. Irvings presentation will be available on BioTimes web site http://www.biotimeinc.com as well as Cell Cure Neurosciences web site at http://www.cellcureneurosciences.com.

Background.

Age-related macular degeneration is the leading cause of blindness in an aging population. It is widely believed that the loss or dysfunction of a particular type of cell called retinal pigment epithelial (RPE) cells is the root cause of the disease. While therapies exist to treat what is called the wet form of macular degeneration exist, there are no therapies for the dry form. The transplantation of healthy RPE cells may provide a superior treatment for this devastating disorder. Cell Cures OpRegen is xeno-free, meaning that no animal products were used in the culture of the human embryonic stem cell-derived RPE cells. The use animal products to culture cells often results in the designation of the therapy as a xenotransplantation product, even though the cells themselves are of human origin. Xenotransplantation may raise purity issues, increasing the costs of product development along with other risks and uncertainties. The production of animal product-free OpRegen will therefore eliminate concerns of xenotransplantation and may provide cost savings in development and production should the product successfully complete clinical trials and be approved for human use.

About Cell Cure Neurosciences Ltd.

Cell Cure Neurosciences Ltd. was established in 2005 as a subsidiary of ES Cell International Pte Ltd (ESI), now a subsidiary of BioTime, Inc. (NYSE Amex:BTX). Cell Cure is located in Jerusalem, Israel on the campus of Hadassah University Hospital. Cell Cure's mission is to become a leading supplier of human cell-based therapies for the treatment of retinal and neural degenerative diseases. Its technology platform is based on the manufacture of diverse cell products sourced from clinical grade (GMP) human embryonic stem cells. Its current programs include developing cells for the treatment of macular degeneration, Parkinson's disease, and cells potentially useful in treating multiple sclerosis. Cell Cure's major shareholders include: BioTime Inc. (NYSE Amex:BTX), Hadasit BioHoldings Ltd. (Tel Aviv Stock Exchange:HDST) and Teva Pharmaceuticals Industries Ltd (NASDAQ:TEVA). Additional information about Cell Cure can be found on the web at http://www.cellcureneurosciences.com.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, and therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

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Raiders' Rolando McClain: Stem-cell therapy worked well

Posted: April 23, 2012 at 9:12 pm

Oakland Raiders linebacker Rolando McClain turned to stem-cell therapy to deal with the aches and pains that come with being a professional football player, the Mobile Press-Register reported Sunday.

Reuter: Impact LB prospects

According to the newspaper, McClain, who missed only one game last season but was hampered by knee pain and an ankle injury, had stem cells taken from his own fat and injected into his knee and leg. McClain credits the procedure for helping him do what he needs to do to prepare for the 2012 season.

"It feels a lot better," McClain told the newspaper, adding he has been able to work out "with hardly any pain at all."

Jason R. Williams, the radiologist who performed the procedure in Alabama, called the experimental therapy "the future of medicine." However, the newspaper also reported that the FDA has warned consumers about the possible pitfalls of stem-cell treatments.

"There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body," said Stephanie Simek, deputy director of the FDA's Office of Cellular, Tissue and Gene Therapies, in a statement.

The newspaper reported that McClain and fellow University of Alabama product Marquis Maze have sought the treatment. Peyton Manning, who recently joined the Denver Broncos after missing the 2011 season with neck issues, reportedly also had a similar procedure outside of the country.

While McClain might be feeling healthier, he has other issues to contend with this offseason. The Birmingham News reported earlier this month that the two-year NFL veteran settled with an Alabama student who claimed McClain struck him with a vehicle and physically assaulted him.

According to the News, McClain also is facing a May 17 trial after allegedly firing a gun in an altercation with a man in November.

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In case you missed it: Test cheating, stem cells and lady golfers

Posted: April 23, 2012 at 1:10 pm

MOBILE, Alabama -- Here's what people are talking about this morning:

A lot more generous - It's been two years since the Deepwater Horizon oil spill and some say claimants of a proposed court settlement will likely get a better deal than those who applied at the Gulf Coast Claims Facility run by

Test cheating - The principal and two staff members at Scarborough Middle School in Mobile were fired in 2008 over a cheating incident involving test answers that were erased and changed in what school officials say was the worst case of cheating in the Mobile County School System.

A new therapy - A clinic in Gulf Shores is offering a new stem cell therapy to help repair joint and muscle damage for some famous patients.

The girls are back in town - The Mobile Bay LPGA Classic begins Thursday, and the area will be hosting 144 golfers vying for the title.

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In case you missed it: Test cheating, stem cells and lady golfers

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'Housekeeping' mechanism for brain stem cells discovered

Posted: April 23, 2012 at 1:10 pm

ScienceDaily (Apr. 22, 2012) Researchers at Columbia University Medical Center (CUMC) have identified a molecular pathway that controls the retention and release of the brain's 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 April 22in 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."

More research needs to be done before the findings can be applied therapeutically, Dr. Iavarone said. "Multiple studies show that NSCs respond to insults such as ischemic stroke or neurodegenerative diseases. If we can understand how to manipulate the pathways that determine stem cell fate, in the future we may be able to control NSC properties for therapeutic purposes."

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'Housekeeping' mechanism for brain stem cells discovered

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Raiders' Rolando McClain: Stem-cell therapy worked well

Posted: April 23, 2012 at 1:10 pm

Oakland Raiders linebacker Rolando McClain turned to stem-cell therapy to deal with the aches and pains that come with being a professional football player, the Mobile Press-Register reported Sunday.

Reuter: Impact LB prospects

According to the newspaper, McClain, who missed only one game last season but was hampered by knee pain and an ankle injury, had stem cells taken from his own fat and injected into his knee and leg. McClain credits the procedure for helping him do what he needs to do to prepare for the 2012 season.

"It feels a lot better," McClain told the newspaper, adding he has been able to work out "with hardly any pain at all."

Jason R. Williams, the radiologist who performed the procedure in Alabama, called the experimental therapy "the future of medicine." However, the newspaper also reported that the FDA has warned consumers about the possible pitfalls of stem-cell treatments.

"There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body," said Stephanie Simek, deputy director of the FDA's Office of Cellular, Tissue and Gene Therapies, in a statement.

The newspaper reported that McClain and fellow University of Alabama product Marquis Maze have sought the treatment. Peyton Manning, who recently joined the Denver Broncos after missing the 2011 season with neck issues, reportedly also had a similar procedure outside of the country.

While McClain might be feeling healthier, he has other issues to contend with this offseason. The Birmingham News reported earlier this month that the two-year NFL veteran settled with an Alabama student who claimed McClain struck him with a vehicle and physically assaulted him.

According to the News, McClain also is facing a May 17 trial after allegedly firing a gun in an altercation with a man in November.

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Raiders' Rolando McClain: Stem-cell therapy worked well

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New Stem Cell Discovered In The Brain

Posted: April 23, 2012 at 1:10 pm

April 21, 2012

Researchers have discovered a new stem cell in the adult brain a discovery which could lead to new treatments for strokes and neurodegenerative conditions.

The discovery was made by researchers at Lund University in Sweden, who found the stem cells located around small blood vessels in the brain while analyzing brain tissues obtained from biopsies.

These cells can proliferate and form several different cell types, including new brain cells, and while their exact function is unclear at this point, experts hope they can lead to the discovery of new methods in order to heal and repair diseases and injuries of the brain.

A similar cell type has been identified in several other organs where it can promote regeneration of muscle, bone, cartilage and adipose tissue, Dr, Patrik Brundin, senior author of the study, Head of the Neuronal Survival Unit at Lund University, and Jay Van Andel Endowed Chair in Parkinsons Research at Van Andel Institute (VAI), said in a press release on Thursday.

According to Sue Thoms of MLive.com, stem cells have been proven capable of healing and repairing injuries in other organs, and if Brundin and his colleagues hope to achieve similar results with the stem cells found in the brain, they will first have to try to control and enhance the cells self-healing properties. The goal, they say, will be to carry out therapies targeted to a specific location within the brain itself.

Our findings show that the cell capacity is much larger than we originally thought, and that these cells are very versatile, said Dr. Gesine Paul-Visse, primary author of the study, which has been published in the journal PLoS ONE, and an associate professor of neuroscience at Lund University.

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

Source: RedOrbit Staff & Wire Reports

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New Stem Cell Discovered In The Brain

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Pitcher hopes stem cell procedure will get him one last season

Posted: April 23, 2012 at 1:10 pm

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

Posted: April 23, 2012 at 1:10 pm

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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