Yearly Archives: 2017


Stem Cell Clinic > 2017

Novartis says US regulator grants speedy review of CAR-T cell therapy – Fox News

By Uncategorized

ZURICH Novartis AG on Wednesday said the U.S. Food and Drug Administration (FDA) has agreed to accelerate its review of the Swiss drugmaker's CTL019 therapy for young patients with B-cell acute lymphoblastic leukemia.

The move would keep Novartis on track with the development of its so-called chimeric antigen receptor T cell therapy, or CAR-T, in partnership with University of Pennsylvania researchers.

ZARA FOUNDER TO SPEND $344M ON BREAST CANCER-SCREENING FOR SPANISH HOSPITALS

The therapy involves a patient's own T-cells being altered in the lab to help the immune system find and kill cancer cells before being re-infused into the patient.

Basel-based Novartis' first CAR-T therapy license application with the FDA has put the company in pole position with regulators as it pushes for approval alongside rivals including biotech Kite Pharma Inc that are developing similar therapies.

"With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options," Vas Narasimhan, Novartis head of drug development, said in a statement.

CTL019 will likely cost hundreds of thousands of dollars per patient if approved, and Novartis counts it among drugs it believes will eventually exceed $1 billion in annual sales.

DEVON AND LEAH STILL CELEBRATE TWO YEARS IN REMISSION

In a Phase II study, Novartis said 82 percent of patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery at three months after treatment. In December, Novartis estimated that 60 percent of those responders were relapse-free after six months.

The company plans to submit an application for market authorization with the European Medicines Agency (EMA) later this year.

Read the original:
Novartis says US regulator grants speedy review of CAR-T cell therapy - Fox News

ViaCyte taps Gore to develop delivery devices for diabetes cell … – FierceBiotech

By Uncategorized

ViaCyte, which is working on stem cell-based therapies for diabetes, has partnered with W.L. Gore to develop a delivery device for cell therapies that will protect the cells from being rejected by patients immune systems.

ViaCyte is developing a treatment that deliversstem cell-derived islet replacement therapies for patients with Type 1 diabetes and some patients with Type 2 diabetes, according to a statement.

The PEC-Encap product combines a delivery device, the Encaptra Cell Delivery System, with PEC-01 pancreatic progenitor cells. The Encaptra system delivers the PEC-01 stem cellswhich have the ability to grow into insulin-producing pancreatic cellsand shields them from the host immune response, which removes the need forimmunosuppressive drugs.

While the combo treatment has shown promise in early, preclinical evaluation, nonclinical results have shown that modifying the Encaptra device could improve PEC-Encap, ViaCyte said in the statement. The engraftment of the stem cells could also be improved.

As ViaCyte advances our next generation encapsulation technologies for cell therapies, Gores contribution to the material and design improvements of the Encaptra delivery system is expected to support the reliable and robust long-term engraftment that is required for the PEC-Encap product to be most effective, said ViaCyte CEO Paul Laikind, in the statement. With Gores help, we plan to improve on the results we have seen with PEC-Encap, which would then have the potential of benefiting all patients with insulin-requiring diabetes, both type 1 and type 2.

ViaCyte and Gore first looked into collaborating in 2016, said Edward Gunzel, technical leader for Gore PharmBIO Products, in the statement. The companies have created a joint development team. Financial details were not disclosed.

Read this article:
ViaCyte taps Gore to develop delivery devices for diabetes cell ... - FierceBiotech

Pioneering stem cell gene therapy cures infants with bubble baby disease – UCLA Newsroom

By Stem Cell Treatment

FINDINGS

UCLA researchers have developed a stem cell gene therapy cure for babies born with adenosine deaminase-deficient severe combined immunodeficiency, a rare and life-threatening condition that can be fatal within the first year of life if left untreated.

In a phase 2 clinical trial led by Dr. Donald Kohn of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Researchat UCLA, all nine babies were cured. A 10th trial participant was a teenager at the time of treatment and showed no signs of immune system recovery. Kohns treatment method, a stem cell gene therapy that safely restores immune systems in babies with the immunodeficiency using the childs own cells, has cured 30 out of 30 babies during the course of several clinical trials.

Adenosine deaminase-deficient severe combined immunodeficiency, also known as ADA-SCID or bubble baby disease, is caused by a genetic mutation that results in the lack of the adenosine deaminase enzyme, which is an important component of the immune system. Without the enzyme, immune cells are not able to fight infections. Children with the disease must remain isolated in clean and germ-free environments to avoid exposure to viruses and bacteria; even a minor cold could prove fatal.

Currently, there are two commonly used treatment options for children with ADA-SCID. They can be injected twice a week with the adenosine deaminase enzyme a lifelong process that is very expensive and often does not return the immune system to optimal levels. Some children can receive a bone marrow transplant from a matched donor, such as a sibling, but bone marrow matches are rare and can result in the recipients body rejecting the transplanted cells.

The researchers used a strategy that corrects the ADA-SCID mutation by genetically modifying each patients own blood-forming stem cells, which can create all blood cell types. In the trial, blood stem cells removed from each childs bone marrow were corrected in the lab through insertion of the gene responsible for making the adenosine deaminase enzyme. Each child then received a transplant of their own corrected blood stem cells.

The clinical trial ran from 2009 to 2012 and treated 10 children with ADA-SCID and no available matched bone marrow donor. Three children were treated at the National Institutes of Health and seven were treated at UCLA. No children in the trial experienced complications from the treatment. Nine out of ten were babies and they all now have good immune system function and no longer need to be isolated. They are able to live normal lives, play outside, go to school, receive immunizations and, most importantly, heal from common sicknesses such as the cold or an ear infection. The teenager, who was not cured, continues to receive enzyme therapy.

The fact that the nine babies were cured and the teenager was not indicates that the gene therapy for ADA-SCID works best in the youngest patients, before their bodies lose the ability to restore the immune system.

The next step is to seek approval from the Food and Drug Administration for the gene therapy in the hopes that all children with ADA-SCID will be able to benefit from the treatment. Kohn, who is a professor of pediatrics and microbiology, immunology and molecular genetics at the David Geffen School of Medicine at UCLA, and colleagues have also adapted the stem cell gene therapy approach to treat sickle cell disease and X-linked chronic granulomatous disease, an immunodeficiency disorder commonly referred to as X-linked CGD. Clinical trials providing stem cell gene therapy treatments for both diseases are currently ongoing.

Kohn is a member of the UCLA Jonsson Comprehensive Cancer Centerand member of the UCLAChildrens Discovery and Innovation Institute at Mattel Childrens Hospital. The first author of the study is Kit Shaw, director of gene therapy clinical trials at UCLA.

The research was published in the Journal of Clinical Investigation.

The research was funded by grants from the U.S. Food and Drug Administrations Orphan Products Clinical Trials Grants Program (RO1 FD003005), the National Heart, Lung and Blood Institute(PO1 HL73104 and Z01 HG000122), the California Institute for Regenerative Medicine (CL1-00505-1.2 and FA1-00613-1), the UCLA Clinical and Translational Science Institute (UL1RR033176 and UL1TR000124) and the UCLA Broad Stem Cell Research Center.

View original post here:
Pioneering stem cell gene therapy cures infants with bubble baby disease - UCLA Newsroom

Woman to hold West Lothian stem cell drive after treatment saved brother-in-law’s life – Scottish Daily Record

By Stem Cell Treatment

A woman will hold a stem cell registration drive in Livingston after treatment saved her brother-in-laws life when he was diagnosed with leukaemia.

Claire Craig will host the drive for charity DKMS two years after her brother-in-law Jamie, from Livingston, received life-saving stem cell treatment thanks to the help of a donor from Germany.

Jamie was diagnosed with Acute Myeloid Leukaemia in August 2014 aged 31 and was given only an 18 per cent chance of survival unless a stem cell donor match was found.

With none of his five siblings proving to be a match, Jamie finally received good news in October 2014 that a female donor had been found in Germany, by February 2015 Jamie was in remission.

Read more: Woman celebrates her 107th birthday West Lothian

Inspired by her brother-in-laws story Claire has decided to hold a drive for the stem cell charity at the Salvation Army hall in Howden, Livingston, on June 1, with 10-minute slots available from 11am to 6 pm.

Claire, who now lives in Berwick, said: I have decided to hold this event, hopefully to raise awareness and get as many people as I can to sign up to be on the register.

To join the register all we need is a simple, painless swab of the inside of both cheeks, along with some basic contact details. This will take less than ten minutes but could give someone a second chance of life.

This is the second drive Claire has held after hosting one in Berwick last month and she hopes to encourage as many 17 to 55-year-olds as possible to sign up for the register.

Read more: West Lothian Council election candidates announced

Lisa Nugent, head of donor recruitment at blood cancer charity DKMS, said: Were grateful to Claire for hosting the donor drive event in Livingston and call on anyone aged between 17 and 55 years and in general good health to register at the event or by visiting http://www.dkms.org.uk.

She added: Every 20 minutes someone in the UK is diagnosed with a blood cancer. Finding a blood stem cell match from a genetically similar person can offer the best treatment, a second chance of life. Thats why DKMS exists to register people as a blood stem cell donor and become a potential life-saver it costs just 40 to register a new donor.

Anyone who wants to register can visit http://www.facebook.com/dkmssignuplivingston or contact Claire on 07826 516504.

Read the original:
Woman to hold West Lothian stem cell drive after treatment saved brother-in-law's life - Scottish Daily Record

UConn Professor conducting T and stem cell research to treat cancer, autoimmune disease – UConn Daily Campus

By Stell Cell Research

Laijun Lai, an Associate Research Professor at the University of Connecticut is currently doing research to find treatment for cancers, autoimmune deficiencies and genetic diseases through the use of T cells and stem cells.

The first area of his research focuses on gene engineering approaches to treating cancers and autoimmune diseases.

Lais research has resulted in two patents and several grants from NIH, the American Cancer Society and the Connecticut Regenerative Medicine Fund.

We are very excited with our results. We believe that our research will eventually lead to the new approach in the treatment of cancer, autoimmune diseases or genetic diseases, such as (DGS), Lai said.

The progression of cancerous tumors is accompanied by a very significant suppression of the immune system, which interferes with the bodys ability to send an effective immune response in order to eliminate chemotherapy, Lai said.

In terms of autoimmune disease, disorders develop when the immune system targets and destroys the bodys own tissues, Lai said.

Therefore, the study investigates new approaches to enhance T cell function for use in the treatment of cancer, while also looking for new ways to inhibit T cell function to treat autoimmune disease, Lai said.

Several T cell inhibitor molecules have been identified. Were trying to find a new T cell inhibitor molecule by using the bioinformatic approach to identify several new genes that are related to T cell inhibitor molecules, Lai said.

He then used the gene engineering approach to produce recombinant proteins from these genes. And these preliminary studies have shown that in a dish, the proteins can inhibit T cell function.

By using the gene engineering approach we can enhance the immune function that can fight a lot of diseases, such as cancer and infections, Lai said.

The second area of my research is using stem cell technology to prevent and treat autoimmune disease, Lai said.

The thymus, an organ of the immune system, is the primary organ that naturally produces T cells for the body.

Thymic epithelial cells (TECs) mediate T cell selections, generating T cells that are able to react with foreign antigens, such as bacteria and viruses, Lai said.

In the prevention or treatment of autoimmune diseases, it would induce immune tolerance of certain antigens by using the mechanisms that would occur in the thymus under normal circumstances, Lai said.

However, the thymus undergoes age-dependent involution resulting in a serious compromise of T cell function in the elderly, Lai said. Many studies have shown that embryonic stem cells (ESCs) or pluripotent stem cells (iPSCs) have huge potential to treat many diseases because these cells can change into many types of cells in a dish.

Through the transplantation of ESCs can cause immune tolerance to the disease causative self-antigens and treat or even prevent autoimmune diseases such as Multiple Sclerosis, Lai wrote in a research statement.

The third area of my research is using stem cell technology to model and treat genetic diseases such as DiGeorge Syndromealso known as DGS, Lai said.

DGS is one of the most common genetic diseases in humans.

One of the characteristic features of DGS is that the patient has a profound thymic aplasia or hypoplasia that results in T cell immunodeficiency, Lai said, So we are going to determine the ability of ESC-derived TECs to prevent and treat DGS.

More:
UConn Professor conducting T and stem cell research to treat cancer, autoimmune disease - UConn Daily Campus

Stem cell centre coming to Kamloops? – CFJC Today Kamloops

By Stell Cell Research

KAMLOOPS My curiosity was sparked when I read that a stem cell centre was opening in Kamloops (Kamloops This Week, March 21, 2017).

So I went to the location of the centre at 470 Columbia St only to find a parking lot. Thinking that the address might be wrong, I searched the directory of the medical building next door and found that no stem cell centre was listed.

The Stem Cell Centers website lists Kamloops as the only one in Canada. Dr. Richard Brownlee is named as the surgeon with more information coming soon.

Stem cell therapy, says the website, can help with orthopedic or pain management, ophthalmological conditions, cardiac or pulmonary conditions, neurological conditions, and auto-immune diseases, among many other conditions and disease that results in damaged tissue.

One of the ophthalmological conditions they treat is macular degeneration. If your vision is fading due to macular degeneration, you know its time to seek help. Our non-invasive Stem Cell Therapy treatment might be the solution for you.

I wanted get Dr. Brownlees reaction to news that an unproven stem cell treatment had resulted in blindness according to the New England Journal of Medicine as reported in the Globe and Mail, March 20, 2017.

This week, the New England Journal of Medicine (NEJM) reported on three individuals who went blind after receiving an unproven stem cell treatment at a Florida clinic. The patients paid thousands of dollars for what they thought was a clinical trial on the use of stem cells to treat macular degeneration.

The writer of the Globe and Mail article, Timothy Caulfield, Research Chair of the in Health Law and Policy at the University of Alberta, doesnt name the Florida clinic.

The Stem Cell Centers website refers optimistically to treatment for macular degeneration at a Florida clinic, although apparently not theirs since no Florida clinic appears on their list. It tells of how Doug Oliver suffered from macular degeneration before stem cells were extracted from his hip bone and injected them into his eyes. Almost immediately, Olivers eyesight started to improve. I began weeping, he said.

Caulfield encourages caution. Health science gets a lot of attention in the popular press. People love hearing about breakthroughs, paradigm shifts and emerging cures. The problem is, these stories are almost always misleading. It can also help to legitimize the marketing of unproven therapies.

Reports from the Stem Cell Centers own website are cautionary as well. It quotes an abstract from a study done by the Southern California College of Optometry on how stem cells might ultimately be used to restore the entire visual pathway.

The promise of stem cell research is phenomenal. Scientific American (Jan., 2017) reports that brains can be grown in a lab dish from stem cells taken from skin. These samples can be used to research brain disorders ranging from schizophrenia to Alzheimer's disease, and to explore why only some babies develop brain-shrinking microcephaly after exposure to the Zika virus.

However, Dr. George Daley, dean of Harvard Medical School, concludes that there are only a handful of clinical applications available and they are for skin and blood-related ailments.

Practice, it seems, has not yet matched the promise of stem cell research.

More here:
Stem cell centre coming to Kamloops? - CFJC Today Kamloops

New research finds novel method for generating airway cells from stem cells – Medical Xpress

By Stell Cell Research

March 30, 2017

Researchers have developed a new approach for growing and studying cells they hope one day will lead to curing lung diseases such as cystic fibrosis through "personalized medicine."

Researchers at the Center for Regenerative Medicine (CReM) at Boston University School of Medicine (BUSM) and Boston Medical Center (BMC) have discovered that one particular signaling pathway, Wnt, helps direct lung development. A signaling pathway is how developing cells get instruction on what types of cell to become, such as a liver cell, a skin cell, a brain cell, etc.

Using this finding, researchers implemented a new way to use stem cells made from any individual, including cells from patients with cystic fibrosis, and turn them into airway cells, which they then grew into three-dimensional spheres. These airway spheres now can be used to study cystic fibrosis disease activity using a specific test called a swelling assay.

"Because airway spheres from a patient with cystic fibrosis do not swell in our assay but airway spheres from a healthy person do, we can see whether adding a certain drug or combination of drugs causes them to swell more. Finding a drug that causes them to swell might imply that patient would benefit from that treatment," explained corresponding author Darrel Kotton, MD, director of the CReM and Seldin Professor of Medicine at BUSM.

"This study represents our progress towards making airway spheres from any patient with a lung disorder and learning about that patient's disease from those cells. We hope this leads to the ability to design, study and test new therapies for every patient on their own cells in the lab, leading to new treatments and breakthroughs in personalized medicine for individuals with a variety of lung diseases, including cystic fibrosis," explained lead author Katherine McCauley, a PhD student at BUSM.

The researchers believe this process can be used to study other lung diseases such as asthma and emphysema.

The findings are published in the journal Cell Stem Cell.

Explore further: Researchers engineer new thyroid cells

Researchers have discovered a new efficient way to generate thyroid cells, known as thyrocytes, using genetically modified embryonic stem cells.

The lungs contain a thin layer of fluid known as the airway surface liquid (ASL), which helps protect against pathogens. The appropriate ASL volume, pH, and ionic composition are required for optimal airway defense. Cystic ...

Researchers at the University of Toronto and the Hospital for Sick Children (SickKids) are paving the way towards individualized medicine for patients with cystic fibrosis.

Scientists at the University of Cambridge have successfully created 'mini-lungs' using stem cells derived from skin cells of patients with cystic fibrosis, and have shown that these can be used to test potential new drugs ...

It may be possible one day to treat several lung diseases by introducing proteins that direct lung stem cells to grow the specific cell types needed to repair the lung injuries involved in the conditions, according to new ...

Researchers from the European Bioinformatics Institute (EMBL-EBI), University of Cambridge, the Wellcome Trust Sanger Institute and the Cancer Research UK-Cambridge Institute (CRUK-CI) have shed light on a long-standing debate ...

(Medical Xpress)A team of researchers from several institutions in the U.K. and one in the U.S. has developed a faster and cheaper way to figure out which drugs on the market might be useful for treating other ailments. ...

Gaucher disease is a genetic disorder of lipid metabolism. Sphingosine, a compound as enigmatic as the sphinx, plays a key role in this metabolic disorder. Scientists from the Bonn research center caesar have identified some ...

Researchers have developed a new approach for growing and studying cells they hope one day will lead to curing lung diseases such as cystic fibrosis through "personalized medicine."

They may seem rigid and set in their ways, but your bones are actually under constant construction and deconstruction. They give up their nutrient treasures (calcium) to the body and then rebuild in a constant give-and-take ...

Activated by cold, the small amounts of brown fat scattered around your body can burn calories to warm you up. They also can help to lower insulin resistance and other conditions implicated in type 2 diabetes and obesity. ...

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

View original post here:
New research finds novel method for generating airway cells from stem cells - Medical Xpress

U.S. Stem Cell, Inc. and Advanced Stem Cell Rx Develop Strategic Alliance – Yahoo Finance

By Stell Cell Research

SUNRISE, FL / ACCESSWIRE / March 30, 2017 / U.S. Stem Cell, Inc. (USCC) (USRM), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has developed a strategic alliance with Advanced Stem Cell Rx (ASC), a US based provider of regenerative medicine programs, including the development of autologous stem cell treatment centers throughout the US.

"Stem cells are critical to our survival and at the core of our regenerative and healing powers. They will play an immense role in redefining the preferred treatment method for the majority of diseases commonly afflicting mankind. We, at ASC, are proud to form a strong alliance with US Stem Cell Inc., one of the oldest and most respected stem cell research and therapy companies in the world," stated Dr J.S. Landow, Managing Director of ASC.

ASC is commercializing many of the proprietary treatments developed by USSC and is currently implementing turnkey programs into qualified practices across the U.S. ASC has contracted with practices in over 20 states in the US. The company utilizes treatments which employ over 20 years of US Stem Cell's international research findings and among the world's elite cellular scientists and other luminaries in the stem cell field. Patient selection is critical, with acceptance for treatment based upon patient's meeting specific criteria and undergoing a consultation with a member of the clinical team.

About U.S. Stem Cell, Inc.

US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development, and commercialization of cell based therapeutics that prevent, treat, or cure disease by repairing and replacing damaged or aged tissue, cells, and organs, and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases, ultimately, we contend, lessening patient burdens, as well as reducing the associated economic impact disease imposes upon modern society.

Our business, which includes three operating divisions (US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic), includes the development of proprietary cell therapy products, as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities, as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

Forward-Looking Statements:

Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue," or the negative other variations thereof, or comparable terminology, are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors," in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

Read More

Media Contact:

U.S. Stem Cell, Inc. 13794 NW 4th Street, Suite 212 Sunrise, Fl 33325 Phone: 954.835.1500 Email: usstemcell@us-stemcell.com

SOURCE: U.S. Stem Cell, Inc.

More here:
U.S. Stem Cell, Inc. and Advanced Stem Cell Rx Develop Strategic Alliance - Yahoo Finance

Local Doctor Working To ‘Brew Blood’ To Combat Certain Disorders – CBS Boston / WBZ

By Stem Cell Medical Center

March 28, 2017 6:44 PM By Dr. Mallika Marshall

BOSTON (CBS) An everyday problem in the medical community is a lack of blood donations which are needed for transfusions worldwide.

Aware of this issue, scientists are working on a procedure that could brew blood to help combat certain blood disorders.

Scientists work on brewing blood to end lack of blood supply. (WBZ-TV)

As a child in Jamaica, Claud DAguilar was diagnosed with sickle cell disease. Its something thats genetic. It starts from birth so basically youre going through this forever and ever. Amen. Until you die.

Sickle cell disease causes red blood cells to become curved and rigid, leading to severe pain.

Hell on wheels, explained DAguilar. The most excruciating pains you could think about. Something I wouldnt wish on my worst enemy.

Anemia is another common complication and often requires multiple blood transfusions. Thats where George Murphy, PhD, a stem cell scientist at the Center for Regenerative Medicine at Boston Medical Center, enters the picture.

Dr. George Murphy, stem cell scientist, explains the brewing blood process. (WBZ-TV)

We like to actually work on diseases that directly impact this under-served community, one of which is sickle cell disease, said Murphy.

He and his team are working on growing personalized blood cells in the lab that could one day help patients like DAguilar.

In essence, sort of brew blood, said Murphy.

Blood being brewed in lab. (WBZ-TV)

Using a small sample of a patients own blood, scientists can reprogram red blood cells back into master stem cells and then coax them back into red blood cells that are unique to that patient. They can then grow the red blood cells over and over again in the lab.

We could actually make a stem cell line from those particular patients who suffer from sickle cell disease, says Murphy.

Such personalized blood could meet a patients transfusion demands and even reduce the effects of the disease. DAguilar said that would be a win.

Scientist rotates brewed blood in sac. (WBZ-TV)

Not only for me but other people suffering, he said. That would be a godsend.

The process could assist millions of people worldwide who need blood products.

You could actually make a universal supply of blood that could be transfused into anyone, says Murphy.

Although not ready for prime time yet, stem cell derived blood could be available for transfusions in the general population, as Murphy says, Sooner than you think.

Follow Dr. Mallika Marshall on Twitter Mallika Marshall, MD, is an Emmy-award winning journalist and physician who serves as the regular Health Reporter at WBZ-TV in Boston. A practicing physician who is Board Certified in both internal medicine a...

Continued here:
Local Doctor Working To 'Brew Blood' To Combat Certain Disorders - CBS Boston / WBZ

Study points to dangers in unproven stem cell treatments in local clinics – Miami’s Community Newspapers

By Stem Cell Clinic

Three South Florida women suffered serious loss of vision soon after receiving stem cell treatments for age-related macular degeneration (AMD) at a Broward clinic in 2015, according to a study published today recently in the New England Journal of Medicine.

The retinal detachments, bleeding in the eyes and other blinding complications in these three patients raise concerns about stem cell clinics that charge patients for their services and that lack clinical data to support their practices, said Thomas Albini, MD, associate professor of clinical ophthalmology at Bascom Palmer Eye Institute and co-author of the study.

Albini said the three patients ages 72, 78 and 88 were concerned about losing their independence, including the ability to drive, due to AMD, a disorder that involves the gradual loss of the eyes photoreceptor cells and the leading cause of vision loss among elderly patients in the United States.

Patients seeking stem cell treatments for medical problems should only consider a carefully controlled clinical trial at an academic medical center, Albini said. Paying thousands of dollars to a local clinic for an unproven stem cell treatment as these patients did is extremely risky with a low probability of a successful outcome.

Five other Bascom Palmer physicians were co-authors of the study, Vision Loss after Intravitreal Injection of Autologous Stem Cells for AMD, in the journal: Ajay E. Kuriyan, MD; Justin H. Townsend, MD; Marianeli Rodriguez, MD, PhD; Philip J. Rosenfeld, MD, PhD; and Harry W. Flynn Jr., MD. Other co-authors were faculty members from the University of Rochester Medical Center; Dean McGee Eye Institute, University of Oklahoma; Center for Sight, Sarasota, and Byers Eye Institute, Stanford University.

In the study, the Bascom Palmer ophthalmologists discussed how the Broward clinic (its name was not disclosed) first harvested stem cells from the adipose fat tissues of the three patients and then injected the cells into both eyes of each patient.

Within 36 hours of their treatment at the Broward clinic, two of the three patients sought emergency care at Bascom Palmer for serious blinding conditions including ocular hypertension, vitreous hemorrhage, retinal detachment, and/or lens dislocation. Although the patients had suffered only moderate vision loss prior to their treatment, a year later their visual acuities ranged from 20/200 to total blindness.

While numerous stem cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem cell clinics are treating patients without that oversight and with potentially little concern for patient safety, Albin isaid. In this instance, these patients paid $5,000 each for a procedure that had never been studied in a clinical trial for possible improvement of vision.

Albini said the patients might have developed vision loss from retinal or optic nerve toxicity from the injected stem cells, enzymes or other materials, or from elevated intraocular pressure (IOP), which damages the optic nerve.

Several cellular therapy approaches are now being investigated by U.S. Food and Drug Administration (FDA) registered and Institutional Review Board (IRB) approved clinical trials, according to the study.

As of Nov. 2, 2016, at least 13 trials were registered on ClinicalTrials.gov studying the role of intravitreal injections of various stem cell populations. However, Albini cautioned that not every trial registered on the site has been approved by an IRB or the FDA.

Some clinics are claiming that treatments using the patients own stem cells dont require FDA oversight or clinical trials, even though there is no evidence the treatments are safe or effective, he said. Almost all legitimate research is funded by an institution or company with an established protocol, lots of pre-clinical data and extensive pre-trial and post-trial evaluations.

For information on Bascom Palmer Eye Institute, contact Marla Bercuson at 305-326-6190 or send email to mbercuson@med.miami.edu, or visit http://www.bascompalmer.org.

Connect To Your Customers & Grow Your Business

View original post here:
Study points to dangers in unproven stem cell treatments in local clinics - Miami's Community Newspapers

→←