Stem Cell Clinic

Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough … – PR Newswire (press release)

By Uncategorized

CAR-T cell therapy is different from typical small molecule or biologic therapies currently on the market because it is manufactured for each individual patient. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.

CTL019 was first developed by the University of Pennsylvania (Penn). In 2012, Novartis and Penn entered into a global collaboration to further research, develop and then commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. Through the collaboration, Novartis holds the worldwide rights to CARs developed with Penn for all cancer indications. In March 2017, Novartis announced that the FDA accepted the company's Biologics License Application filing and granted priority review for CTL019 in the treatment of r/r pediatric and young adult patients with B-cell ALL.

The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study (NCT02445248), which is evaluating the efficacy and safety of CTL019 in adult patients with r/r DLBCL. JULIET is the second global CAR-T trial, following the Novartis ELIANA study (NCT02435849) investigating CTL019 in r/r B-cell ALL. Findings from JULIET are expected to be presented at an upcoming medical congress.

"We are encouraged by the FDA's recognition in the potential of CTL019 for this indication, which follows our promising studies of this therapy for ALL and the FDA filing by Novartis in pediatric and young adult ALL that received priority review," said the Penn team's leader, Carl June, MD, director of the Center for Cellular Immunotherapies in the Perelman School of Medicine at the University of Pennsylvania. "Work with our collaborators at trial sites across the world is paving a path to bring personalized cell therapies to more patients with these devastating blood cancers."

According to FDA guidelines, treatments that receive Breakthrough Therapy designation are those that treat a serious or life threatening disease or condition and demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints based on preliminary clinical evidence. The designation also indicates that the agency will expedite the development and review of CTL019 in adults with r/r DLBCL. This marks the 14th Breakthrough Therapy designation for Novartis since the FDA initiated the program in 2013, underscoring an emphasis to develop innovative treatments in disease areas with significant unmet need.

DLBCL is the most common form of lymphoma and accounts for approximately 30 percent of all non-Hodgkin lymphoma cases1. Ten to 15 percent of DLBCL patients fail to respond to initial therapy or relapse within three months of treatment, and an additional 20 to 25 percent relapse after initial response to therapy2.

Because CTL019 is an investigational therapy, the safety and efficacy profile has not yet been established. Access to investigational therapies is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the therapy. Because of the uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world.

DisclaimerThe foregoing release contains forward-looking statements that can be identified by words such as "Breakthrough Therapy designation," "investigational," "potential," "expected," "eager," "look forward," "priority review," "upcoming," "encouraged," "promising," "yet," "will," or similar terms, or by express or implied discussions regarding potential marketing approvals for CTL019, or regarding potential future revenues from CTL019. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that CTL019 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that CTL019 will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding CTL019 could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisLocated in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis and @NovartisCancer at http://twitter.com/novartiscancer For Novartis multimedia content, please visit http://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com

References

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Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough ... - PR Newswire (press release)

Cell Therapy Report (2017-2026) – Markets & Future Prospects for … – Yahoo Finance

By Uncategorized

DUBLIN--(BUSINESS WIRE)--

Research and Markets has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

The cell-based markets was analyzed for 2016, and projected to 2026. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 305 of these are profiled in part II of the report along with tabulation of 291 alliances. Of these companies, 170 are involved in stem cells. Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 64 Tables and 22 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

Key Topics Covered:

Part I: Technologies, Ethics & Regulations

0. Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit http://www.researchandmarkets.com/research/dw396t/cell_therapy

View source version on businesswire.com: http://www.businesswire.com/news/home/20170417005383/en/

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Cell Therapy Report (2017-2026) - Markets & Future Prospects for ... - Yahoo Finance

First participant treated in trial of stem-cell therapy for heart failure – Medical Xpress

By Stem Cell Treatment

April 18, 2017 by Gian Galassi

A research team at University of Wisconsin School of Medicine and Public Health has treated its first patient in an innovative clinical trial using stem cells for the treatment of heart failure that develops after a heart attack.

The trial is taking place at University Hospital, one of three sites nationwide currently enrolling participants. The investigational CardiAMP therapy is designed to deliver a high dose of a patient's own bone-marrow cells directly to the point of cardiac injury to potentially stimulate the body's natural healing response.

The patient experience with the trial begins with a cell-potency screening test. Patients who qualify for therapy are scheduled for a bone-marrow aspiration. The bone marrow is then processed on-site and subsequently delivered directly to the damaged regions in a patient's heart in a minimally invasive procedure.

"Patients living with heart failure experience a variety of negative symptoms that can greatly impact their day-to-day life," said UW Health cardiologist Dr. Amish Raval, associate professor of medicine and one of the principal investigators for the trial. "By being at the forefront of research for this debilitating condition, we look forward to studying the potential of this cell therapy to impact a patient's exercise capacity and quality of life."

The primary outcome to be measured is the change in distance during a six-minute walk 12 months after the initial baseline measurement.

Heart failure commonly occurs after a heart attack, when the heart muscle is weakened and cannot pump enough blood to meet the body's needs for blood and oxygen. About 790,000 people in the U.S. have heart attacks each year. The number of adults living with heart failure increased from about 5.7 million (2009-2012) to about 6.5 million (2011-2014), and the number of adults diagnosed with heart failure is expected to dramatically rise by 46 percent by the year 2030, according to the American Heart Association (AHA).

The CardiAMP Heart Failure Trial is a phase III study of up to 260 patients at up to 40 centers nationwide. Phase III trials are conducted to measure effectiveness of the intervention, monitor side effects and gather information for future use of the procedure. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack.

Information about eligibility or enrollment in the trial is available at http://www.clinicaltrials.gov, or through a cardiologist.

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Scientists at the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) have discovered a new mechanism of action of metoprolol, a drug that can reduce the damage produced during a heart attack if administered ...

(Medical Xpress)A team of researchers at the University of Nottingham in the U.K. has found that artificial intelligence systems can be better at gauging a patient's risk of a heart attack than doctors using a standard ...

A team of biomedical engineering researchers, led by the University of Minnesota, has created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. The discovery is a major step ...

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People living in areas that restrict trans fats in foods had fewer hospitalizations for heart attack and stroke compared to residents in areas without restrictions, according to a study led by a Yale researcher. This finding ...

UCLA scientists have found that conscious sedationa type of anesthesia in which patients remain awake but are sleepy and pain-freeis a safe and viable option to general anesthesia for people undergoing a minimally invasive ...

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First participant treated in trial of stem-cell therapy for heart failure - Medical Xpress

Cincinnati native hurt in pool party accident accepted into stem cell … – WLWT Cincinnati

By Stell Cell Research

CINCINNATI

An Elder High School grad who was critically injured has been accepted into a stem cell research study at Rush University in Chicago, his family reported.

Ryan Custer, a Wright State University freshman, was injured during a pool party near Miami University earlier this month.

He suffered a traumatic head injury, fracturing his vertebrae and sending him to the intensive care unit at the University of Cincinnati Medical Center.

Family and friends said he's undergone multiple surgeries on his spine, was put on a breathing tube and has had a tracheotomy performed. As of Tuesday, he was talking and breathing on his own for a few hours at a time, and feeling had returned to his feet.

Custer will leave for Chicago to participate in the study as soon as he is able, his family said.

A GoFundMe page has been set up to help Ryan Custer and his family during this difficult time.

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Cincinnati native hurt in pool party accident accepted into stem cell ... - WLWT Cincinnati

5 important ways Henrietta Lacks changed medical science – Stat – STAT

By Uncategorized

H

enrietta Lackss cells have long been familiar to scientists but it was the ethical controversy around those cells that made her famous to the wider world.

Her fame was thanks toan award-winning bookpublished in 2010that explored how, in the course of Lackss treatment for cancer, doctors isolated what becamethe first immortal human cells. The HeLa cells survived, thrived, and multiplied outside her body, so much so that they have been in continual use in labs around the world for 65 years, even though Lacks herself succumbed to cancer in 1951. But their use has raised challenging issuesabout medical samplestaken without consent and how individuals and their familiesshould be compensated for discoveries based on their tissues.

Now, that story is the subject ofan HBO movie coming out later this month, making it an opportune time to reflect on who Henrietta Lacks was and what her cells have contributed to science.Here are just a few of them.

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In the early 1980s, German virologist Harald zur Hausen found that HeLa cells contained multiple copies of human papillomavirus 18 (HPV-18), a strain of HPV later found to cause the type of cervical cancer that killed Lacks. HPV-18 was found to be one of the most dangerous strains of the virus, inserting its DNA into normal cells and forcing them to produce proteins that ultimately lead to cancer. In Lackss case, the virus entered the cells and turned off the gene that would normally have suppressed the formation of tumors. Years later, scientists used that knowledge to developHPV vaccines, which are now widely available and credited with reducing casesof HPV infection in teenage girls by almost two-thirds. Harald zur Hausen won a 2008Nobel prize for his discovery.

The Pap smear: groundbreaking, lifesaving and obsolete?

Because of the seemingly limitless lifespans of Lackss cells, we now understand better how some cells manage to stay young even with the passage of time. Usually, as cells divide either as a person grows or as the body repairs injuries eachdivision lops off the ends of chromosomes, called telomeres. Over time that means that the chromosomes become slightly shorter, which is thought to be a driver of cell aging.

In the 1980s, it was discovered that some animal embryoshad an enzyme called telomerase, whichprotects chromosomes from degrading, allowing the cellsto keep actively dividing. Then, in 1989, Yale scientist Gregg Morin used HeLa cells to isolate the same enzyme in human cells for the first time. Morin hypothesized that this enzyme, found in cancer cells, was also how embryonic cells were able to rapidly divide at the beginning of life. And in 1996, he was proven right, when scientists found telomerase in human embryos which is what allows them to grow so rapidly until birth, when human bodies stop making it.

At the time of Lackss death, polio was one of the worlds most devastating viral diseases. HeLa cells helped make the vaccine available sooner. In the early 1950s, Jonas Salk had already figured out how the vaccine worked; the problem was testing it. Ordinarily, Salk would have tested the vaccine on cells from monkeys. But monkeys and their cells were expensive, especially considering that testing the vaccine actually killed the cells in the process. Ideally, the best cells for testing would be susceptible to infection by the poliovirus, but wouldnt be killed by it. No such cells existed until researchers found HeLa cells. Not only were these cells more susceptible to the virus than the cells scientists previously used, the fast-growing cells were nearly impossible to kill. Scientists at the Tuskegee Institute built a factory to reproduce HeLa cells, allowing Salk to successfully test the vaccine, which in the last 60 years has effectively eliminated polio in most of the countries of the world.

Thousands of studies used the wrong cells, and journals are doing nothing

In in mid-1960s, HeLa cells were fused with mouse cells, creating the first documentedhuman-animal hybrid cells. Those cells, in turn,became important in the early days of gene mapping. Because every hybrid would have a different assortment of human and mouse genes, scientists could look at what proteins a cell did or didnt produce and deduce which human gene they were produced by. Those techniques evolved over time into the fine-scale map of the human genome thatemerged from the Human Genome Project.

European scientists laterpublishedLacks genome, but removed it from public view after her family protested. In 2013, the National Institutes of Health and Lackss descendants releaseda special set of rules for handling the Lacks genome.

Over the years, scientists have infected hardy HeLa cells with various viruses HIV, herpes, Zika, measles, and mumps, to name a few to better understandhow to battle them. They discovered, for instance, that the type of white blood cell called a T cell sports a surface protein called CD4, which is what HIV usesto enter the cell. When CD4 was added to HeLa cells they could be infected with HIV, allowing HIV drugs to be tested on HeLa cells.

Researchers also learned that the measles virusconstantly mutates when it infects HeLa cells, making the disease harder to fight. More recently, microbiologists found that Zika cannot multiply in HeLa cells. Digging further into why that is could produce a new treatment or vaccine for the disease.

Leah Samuel can be reached at leah.samuel@statnews.com Follow Leah on Twitter @leah_samuel

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5 important ways Henrietta Lacks changed medical science - Stat - STAT

Cell Therapy Report (2017-2026) – Markets & Future Prospects for Cell Therapy – Research and Markets – Business Wire (press release)

By Uncategorized

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

The cell-based markets was analyzed for 2016, and projected to 2026. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 305 of these are profiled in part II of the report along with tabulation of 291 alliances. Of these companies, 170 are involved in stem cells. Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 64 Tables and 22 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

Key Topics Covered:

Part I: Technologies, Ethics & Regulations

0. Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit http://www.researchandmarkets.com/research/dw396t/cell_therapy

Continued here:
Cell Therapy Report (2017-2026) - Markets & Future Prospects for Cell Therapy - Research and Markets - Business Wire (press release)

Melbourne woman travelling to Russia for ground-breaking MS stem cell treatment – 9news.com.au

By Stem Cell Treatment

A Melbourne woman is attempting to raise $170,000 for her sister to travel to one of the world's pre-eminent stem cell treatment facilities in an attempt to stop the fatal progression of Multiple Sclerosis.

Chantelle Baker was first diagnosed with MS in May, 2016. In a six month period, 79 lesions had developed on her brain.

"There is no medication to stop the progression of MS," Mrs Baker told A Current Affair.

Chantelle Baker, 41, is hoping to travel to Russia for stem cell treatment to stem the progression of Multiple Sclerosis (Source: A Current Affair)

Mrs Baker, her husband Dara, five-year-old daughter, Lilly, and younger daughter, Edie, are hostages to the hope that Russian doctors can achieve what Australia doctors cannot.

The cost is high, so Mrs Baker's sister, Maxine Parker, has set up an online fundraising campaign to raise the money on her sister's behalf.

"That's my job, I am her big sister," Ms Parker said.

"I have spent 17 years sharing the same bedroom with her growing up and there was no way I was going to let anything take her away from me and I still won't. I am determined to fight this all the way, side-by-side with her."

Mrs Baker's sister, Maxine Parker, has launched a crowd-funding campaign to pay for her sister's treatment in Russia (Source: A Current Affair)

But the cost is nothing compared to the regret the family would face if they didn't give it their all to get Mrs Baker to Russia for the ground-breaking treatment.

"I am scared of not being able to walk, I am scared of waking up one day and not being able to see my kids again because I have gone blind," Mrs Baker said.

"My worst fear is not remembering my children in four or five years' time."

Ms Parker said she would do anything to keep her sister active for her children (Source: A Current Affair)

NSW mother of two Nikki Tatum has just finished the treatment at the same stem cell clinic in Moscow that Mrs Baker is hoping to attend.

Ms Tatum is now back in Australia and will have to wait months before she knows if the therapy worked.

"I have just recently returned from to have HSCT (Hematopoietic Stem Cell Therapy) to hold the progression of my MS," Ms Tatum said in a video message to Mrs Baker.

"I just want to wish you luck for July and let you know that you have made the best choice. The doctors and nurses are just outstanding and you are definitely well looked after."

Mrs Baker, her husband and their children (Source: A Current Affair)

The video message affirmed to Mrs Baker that she was making the right decision.

"It definitely gives me hope. I know I am making the right decision and that is just verifying that I am," Mrs Baker said.

Mrs Baker's husband, Dara, agrees.

"We need to make it work. We need the treatment to work. But of course, I love her to death anyway," Mr Baker said.

Mrs Baker's family have set up a Facebook page where her journey can be followed, Chantelle Fights Multiple Sclerosis.

Nine Digital Pty Ltd 2017

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Melbourne woman travelling to Russia for ground-breaking MS stem cell treatment - 9news.com.au

Billings Clinic accredited for using stem cell method to ‘successfully treat’ a rare cancer – Billings Gazette

By Stem Cell Treatment

The prognosis was dire when Cheryl Grantham learned she had multiple myeloma, a rare form of cancer, in March 1999.

"I thought I'd be dead by Christmas," she said.

The best treatment to extend her life was a round of specialty high-dose chemotherapy, a course more potent than the normal chemotherapy prescribed to combat more common cancers.

Multiple myeloma is cancer of the plasma cells and the high-dose chemotherapy treatments fight it by destroying the cancerous cells in the bone marrow, where plasma originates. The treatments are intense enough that it can kill a patient. But it's one of the most effective ways to treat the cancer.

So doctors a few decades ago created a workaround using stem cells, extracting them from the patient's blood before administering the high-dose chemotherapy and then transplanting them back in to repair the damaged bone marrow after the chemo has been given.

Stem cells are given back to the patient like a blood transfusion, saidBrock Whittenberger, Grantham's doctor at Billings Clinic.

Billings Clinic has been using this stem cell approach with its myeloma cancer treatments for years, and Whittenberger has been the one performing procedure.

"What it's allowed us to do is successfully treat the cancer," he said. "There's a fairly rapid recovery."

Billings Clinic was recently accredited by the Foundation for the Accreditation of Cellular Therapy for its stem cell treatment.With the FACT accreditation, those treatments will be more accessible.

The accreditation also will make it easier for insurance companies to approve the procedure and will allow Billings Clinic to conduct trials on the stem cell treatment.

Billings Clinic is currently the only FACT-accredited center in Montana.

Grantham, who was an infusion nurse at the time of her diganosis, elected to have the treatment and has outlived her initial prognosis by almost two decades.

"I've been fine," she said. "I've been alive for 18 years."

Unexpectedly, the treatments helped her become a better nurse.

"It made me more empathetic," she said.

The stem cell treatment eradicates certain forms of lymphoma but it won't cure Grantham's cancer. At some point themultiple myeloma will return.

Until then, she visits with her doctor every three months for blood work and works to keep her focus on the now.

"With a diagnosis like that you have short-term goals," she said.

Her youngest son was in high school in 1999, and she was still working full time as a nurse. As much as she wanted to crawl under her covers and not face the reality of her cancer diagnosis, she had no choice but to move forward.

"It made me be normal," she said.

And it helped her focus on what was important in the moment. The Christmas before she began her treatments, she took her three sons to the Cayman Islands for the holidays.

"Because everything was going to change," she said."You just do it."

And it's an attitude she still carries. Her youngest son, long graduated from high school, is now married. These days, she's hopeful he'll give her a grandchild.

"That's my goal now," she said, smiling.

Link:
Billings Clinic accredited for using stem cell method to 'successfully treat' a rare cancer - Billings Gazette

Andrews Institute to study stem cells’ impact on knee – Pensacola News Journal

By Stem Cell Treatment

Joseph Baucum , jbaucum@pnj.com Published 4:06 p.m. CT April 16, 2017 | Updated 14 hours ago

Andrews Institute is conducting new stem cell research that could impact the FDA approval of certain treatments. Joseph Baucumjbaucum@pnj.com

Dr. Andrew Anz, an orthopedic surgeon and sports medicine specialist at the Andrews Institute in Gulf Breeze is working on cutting-edge stem cell research for cartilage therapy.(Photo: Tony Giberson/tgiberson@pnj.com)Buy Photo

By the time most reach age 55, Adam Anz estimatesas much as 30 percent of the population will incur some form of knee degeneration, a problem that equals pain and in many cases, surgery.

Its a problem that were all going to face at some point in our lives, said Anz, orthopaedic surgeon at Andrews Institute for Orthopaedics & Sports Medicine.

But in May, a new study will begin at Andrews Institute in Gulf Breeze that could play a game-changing role in evolving the range of medicine available for treating knee injuries. In the process, the research may also help drive down patients costs.

Anz will help spearhead a study next month into increasing the amount of stem cells doctors are able to harvest from bone marrow transplants with the goal of utilizing those cells to regrow cartilage in knees. Cartilage, a tough and flexible material, is essential to the knee, because it acts as a cushion between the bones in the joint. Damaged cartilage can often necessitate knee replacement.

ADDITIONAL CONTENT:Andrews Institute expands prep athletics care in region

In the study, Anz said researchers will attempt to increase the amount of stem cells in participants bone marrow, which would then empty from the marrow into their bloodstream. Researchers would collect the blood, separate the stem cells from it and inject the cells into patients knees. Doctors would then monitor if the marrow cells transform into cartilage cells and spark regeneration.

Its about determining how can we obtain those cells in efficient quantities and put those cells in the right place at the right time to help with healing patients injuries, Anz said.

Because the Food & Drug Administration has not approved the vast majority of stem cell-based remedies, not all treatments involving the cells are available for patients, including the cartilage procedure. For the treatments that are offered, health insurance providers do not cover them without the FDAs consent. Patients who choose to undergo them must pay out-of-pocket prices.

The study at Andrews Institute could push a stem cell cartilage treatment closer to FDA approval and by extension, availability and affordability. The research is an official FDA study. It is led by Khay Yong Saw, a Malaysian physicianwho has already demonstrated conceptual proof of the treatment in an animal study in 2006. He completed a randomized control trial in 2012. This study is the next step in proving the safety and efficacy of the procedure to gain federal endorsement.

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ADDITIONAL CONTENT:Elite athletes just piece of Andrews Institute

Anz, optimistic about the studys potential, emphasized more research must be conducted into the effectiveness of stem cell treatments those already available and those still in the testing phase.

Its important to be excited about technologies, but its also important to be honest with the patients that more must be done to show these treatments are effective, said Anz, who estimated the cartilage study to require two years for participant enrollment and another two years before researchers can observe outcomes.

But some who have undergone stem cell treatments advocate for the procedures federal approval. Jody Falvey, a retired Pensacola resident, had a stem cell procedure conducted at Andrews Institute on her knee in the fall of 2012.

Falvey, 67, tore the medial and lateral meniscus in her knee during a family visit to South Florida while brewing coffee in the morning. The sensation, she said, felt like a knife slicing through her joint.

Following a consultation with Anz, who described an available stem cell treatment known as bone marrow aspirate concentrate, Falvey chose to have the procedure done. The treatment utilized cells from her own body to repair the knee. The process, from procedure to recovery, spanned about two years.

Falvey said her knee does not feel like it ever underwent surgery. The fact that it helped prevent her from having to undergo a knee replacement made the operation even better.

I did not want metal in my body, she said. This was just one of the greatest alternatives I had heard of. I would do it again in a heartbeat.

PENSACOLA NEWS JOURNAL

Andrews Institute expands prep athletics care in region

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Andrews Institute to study stem cells' impact on knee - Pensacola News Journal

Stem Cell Research Advancing Rapidly – Healthline

By Stell Cell Research

Stem cells have been touted as treatments for everything from hair loss to heart disease.

But are those claims scientifically sound?

Research on the technology continues to look promising, but many of its human applications are still preliminary and their effectiveness anecdotal.

Samumed, a $12 billion biotech start-up based in San Diego, profiled this month in Business Insider, exemplifies both sides of the coin.

The company has promised a bevy of age-reversing cures, including regrowing hair, treating wrinkles, and regenerating cartilage in people with osteoarthritis

However, their research isnt conclusive.

None of their treatments have received government approval yet.

Read more: Rheumatoid arthritis and stem cell treatments

Its easy to get excited about all this research.

Samumed Is Trying to Create the Fountain of Youth, says one headline.

Samumed Aims to Reverse Aging with Eternal Youth Treatments, says another.

Combined with $300 million in investment funding, the company has more than just buzz going for it in the biotech industry.

Their treatment for androgenetic alopecia (hair loss) is currently in phase II trials.

Its program to help people with osteoarthritis regrow cartilage in their knees is in phase III.

In total, the company has seven drugs in phase II trials, with plans to expand into more areas of disease research this year.

However, Samumed has raised some eyebrows in the industry with its secrecy. Some skeptics have likened the company to Theranos, a biotech start-up that was valued at $9 billion before an investigation by the Wall Street Journal led to a shutdown of the companys labs.

Samumed has been more open about presenting their data to the public but not about the actual treatments.

We're basically telling everyone, here's proof that it works, Samumed Chief Executive Officer, Osman Kibar, told Business Insider. How it works you just need to wait a little longer because we want to build as much of a head start as we can.

Read more: Stem cell treatments for multiple sclerosis

Beyond the applications of stem cells at Samumed, the technology is also being used to treat some of the United States most widespread health issues.

New research from the American Heart Association this month demonstrated the effectiveness of implanted stem cells into the hearts of people with cardiomyopathy.

Although the sample size was small (only 27 people), scientists noted function and symptomatic improvements of heart functioning as well as less frequency of hospitalization and lower medical costs. They conclude that the stem cell procedure is a feasible treatment for cardiomyopathy, but they note that a larger clinical follow-up is needed for more conclusive results.

In the past week, Newsweek reported on miracle stem cell treatments for burn victims that will promote healing without scars.

Stat News wrote about research on stem cells in mice that could potentially help cure Parkinsons disease.

Read more: Unproved stem cell treatments offer hope and risk

Some researchers in the industry are somewhat measured in their optimism of the technologys human applications.

I want to make sure that we provide a real cautionary note, especially to those individuals and those institutions that tout stem cells as the panacea for any ill, Dr. Cato Laurencin, director of the Institute for Regenerative Engineering at the University of Connecticut, told Healthline.

Laurencin, a medical practitioner at the forefront of stem cell technology, is a firm believer in the benefits of the treatment, but also remains skeptical of some of the claims associated with it.

Much of the evidence is still preliminary or anecdotal, and when people operate on information that is preliminary or anecdotal, there is the possibility for harm, he said.

His work in regenerative engineering a term he coined several years ago looks at the healing properties of implanted stem cells in the human body.

In research published this month, Laurencin and his team concluded that stem cells effectively improved healing to torn rotator cuff tendons in rats.

Rotator cuff tendon tears are a relatively common injury in humans and can be difficult to treat.

Unlike other tendons in the body, the rotator cuff tendon is unable to heal itself, said Laurencin.

Once it is torn, it is liable to be reinjured again and again.

However, the research released this month is about more than just applying stem cells to a certain kind of injury, its about how the stem cells are applied.

Read more: Scientists use 3-D environment to speed up growth of stem cells

Laurencin describes his field as an evolution of earlier work from 30 years ago in tissue engineering: a convergence of bringing together new technologies to create new science and new possibilities.

In this case, nanotechnology is at the heart of this stem cell operation.

Currently there are a variety of ways that stem cells can be implanted into a subject, including injections and bone marrow transplants.

For his research, Laurencin and his team used biomaterial based fiber matrices a nanomaterial conducive to growing and attaching stem cells to implant into the wounded area.

The results are promising, but Laurencin and his team will have to continue working with animals for some time before the process can be applied to humans.

The key is in understanding that stem cells have the potential for more than just regrowing damaged parts of the body.

The way we commonly think about a stem cell is it becoming a new tissue. But were also understanding that the stem cell itself can secrete biological factors that help regeneration occur. Thats what we think is happening here, said Laurencin.

His research into stem cells as a medicinal element in the body could have far reaching implications for all kinds of wound therapy.

Despite his measured approach, Laurencin is still willing to hypothesize about the excitement that the future of the field undoubtedly holds with proper time, funding, and research.

There are newts and salamanders that can regenerate a limb, he told Healthline.

How do we harness the cues that are taking place in these types of animals, and can we utilize what weve learned from these types of animals in humans?

Link:
Stem Cell Research Advancing Rapidly - Healthline

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