Stem Cell Clinic

Kadimastem Granted a Patent in the US for Treatment of Neurodegenerative Diseases – Yahoo Finance

By Stem Cell Medical Center

NESS ZIONA, Israel, March 16, 2017 /PRNewswire/ --

Israeli biotechnology company Kadimastem (KDST.TA), announced that it has been granted a patent from the United States Patent and Trademark Office for its technology in the field of cell based treatment for diseases of the nervous system. The United States patent joins additional patents granted in Israel and Europe.

The patent is for the innovative method of producing supporting cells in the central nervous system from stem cells, including myelin-producing cells, and it is the foundation for the company's products in the field treatment of neurodegenerative diseases.

The technology is the fruit of the research of Professor Michel Revel, the company's Chief Scientist, at the Weizmann Institute. The owner of the patent is Yeda Research and Development Company Ltd. According to an agreement between Kadimastem and Yeda, the company had been granted an exclusive license for exclusive use of the patent.

Kadimastem is developing innovative treatments for a number of severe diseases by transplanting cells and tissues differentiated from human stem cells. The patent expands the intellectual property coverage in the American market as part of the company's strategy in the neurodegenerative diseases field in general and ALS in particular.

Yossi Ben-Yossef, Kadimastem's CEO, noted: "With the company's preparations for the first clinical trial of its unique product, the reinforcement of the company's IP is particularly important. The United States is a target market for the company's products for several reasons, including regulatory (the company will conduct the trial according to the outline coordinated with the FDA), strategic collaborations, potential investors and market size. The patent granted in the United States is a substantial asset in each of these aspects."

Professor Michel Revel, the company's Chief Scientist, added: "The granting of the patent is an international recognition of the uniqueness of the technology at the basis of the cell based treatment for ALS, which Kadimastem develops toward the upcoming clinical trial. The patent also has applications in additional nervous system diseases, and it reinforces the company's position in the field."

About Kadimastem

Kadimastem (http://www.kadimastem.com) is a biotechnology company that specializes in the development of human stem cell-based medical solutions for the treatment of diabetes and neurodegenerative diseases, such as ALS and Multiple Sclerosis. The company was founded in August 2009 by Professor Michel Revel and Yossi Ben Yosef, and is traded on the Tel Aviv Stock Exchange (KDST.TA). The company's chairman is Dr. Eli Opper, formerly the Chief Scientist of the Israeli Ministry of Industry, Labor and Trade. The company's investors, in addition to the founders, include Altshuler Shaham Investment House, foreign investors (Julien Ruggieri and Avi Meizler), and additional institutional investors.

Kadimastem was founded based on patent protected technology that was developed at the Weizmann Institute of Science. Based on the company's unique platform, Kadimastem is developing two types of medical applications: A. Regenerative medicine, which repairs and replaces organs and tissue by using functioning cells differentiated from stem cells. The company focuses on transplanting healthy brain cells to support the survivability of nerve cells as cell therapy for ALS, and transplanting insulin-secreting pancreatic cells for the treatment of insulin-dependent diabetes; B. Drug screening platforms, which use functional human cells and tissues to discover new medicinal drugs. The company has two collaboration agreements with leading global pharmaceutical companies.

Kadimastem has an extensive scientific advisory board, featuring prominent scientists and pioneers: in the embryonic stem cells field, Professor Benjamin Reubinoff, Director of the Hadassah Human Embryonic Stem Cell Research Center and Senior Physician at the Department of Obstetrics and Gynecology at the Hadassah University Medical Center; Professor Joseph Itskovich, world renowned expert and pioneer in pluripotent stem cell research and former head of Obstetrics and Gynecology at RAMBAM Medical Center; in the neurodegenerative disease field, Professor Tamir Ben-Hur, Head of the Department of Obstetrics and Gynecology at Hadassah University Medical Center; and in the diabetes field, Professor Shimon Efrat, professor of Human Molecular Genetics and Juvenile Diabetes at Tel Aviv University and a world renowned expert in cell replacement therapy for diabetes and Professor Eddy Karnieli, former Director of the Institute for Endocrinology, Diabetes and Metabolism at the RAMBAM Medical Center, and a world renowned expert in these fields.

Contact: Kadimastem Yehuda Feinberg +972-73-7971600 y.feinberg@kadimastem.com

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Kadimastem Granted a Patent in the US for Treatment of Neurodegenerative Diseases - Yahoo Finance

Reversing Aging of Intestinal Stem Cells – Technology Networks

By Stem Cell Medical Center

Intestinal stem cells rejuvenate daily so bowels will stay healthy and function normally, but a new study in Cell Reports suggests they also age along with people and lose their regenerative capacity.

Reporting their data online March 14, researchers suggest that reactivating the signaling of a key molecule lost in aging intestinal stem cells could restore healthy intestinal function in older people. The study was conducted in mice and human intestinal organoids by scientists at Cincinnati Childrens Hospital Medical Center and the Institute for Molecular Medicine, Stem Cells and Aging at the University of Ulm in Germany.

Researchers say their study is the first to indicate that intestinal stem cells which allow different intestinal cell types to renew themselves age as people do. It also is the first to provide clear evidence that diminished signaling in intestinal stem cells (ISCs) by the Wnt protein which is important to cell proliferation and renewal drives the aging process and loss of ISCs ability to rejuvenate intestinal tissues.

Deterioration of Wnt signaling in aging intestinal stem cells may help explain imbalances in food and nutrient absorption in older people, but our paper also shows that biology allows us to reverse this process by restoring Wnt signaling, said Hartmut Geiger, PhD, senior investigator of the study. Pharmacologic interventions will still need to be designed based on this finding, but we know now where to start.

Geiger is a member of the Division of Experimental Hematology and Cancer Biology at Cincinnati Childrens.

Old vs. Young

In tests that compared the intestines of young mice (2 to 3 months old) with those of aged mice (approaching 2 years old), researchers noticed significant differences in the structural architecture of intestine.

Intestines from older mice showed a reduced number of crypts (mucosal glands), and the structures were longer and wider than in younger animals. Older intestines also had longer villi (absorptive tissues) and an elevated number of cells. But the researchers also noticed there were fewer numbers of actively dividing cells in the intestines of the older mice.

Study authors then looked for different characteristics in the ISCs of young and old mouse intestines. Although they did not observe differences in the numbers of ISCs, they did see a decreased presence of molecular markers that denote ISC function. This led them to conclude that ISC function diminishes in older intestines.

Finding Wnt

To identify genetically driven molecular processes that prompt aging and diminished function in ISCs (and in Paneth and goblet cells they form) the researchers subjected ISCs to RNA sequencing analysis. These tests showed significant reductions in gene expression in the older cells, including the down regulation of molecular pathways involving the genes PPAR, SMAD and Wnt.

Because Wnt plays a particularly prominent role in regulating ISCs, the researchers focused on this pathway. In young and old mice they tested the presence and strength of the Wnt signaling pathway in cells of the mesenchyme which forms connective and skeletal tissues. The mesenchyme has recently been identified in other studies as providing a supportive environment for ISCs to form.

The authors also tested Wnt signaling in different intestinal cells from young and old mice, specifically goblet and Paneth cells that secrete proteins and antimicrobial peptides that are important to sustaining healthy intestines. In both instances they observed a decline in Wnt in intestinal tissues from the older animals.

In testing on lab-generated human and mouse intestinal organoids, the researchers also observed declines in Wnt signaling in older intestines along with altered intestinal structures and indications of diminished function.

Molecular restoration

Researchers concluded their study by testing the restoration of Wnt signaling in intestines by adding Wnt3a (an inducer of Wnt signaling) in aged mouse and human organoid models, which were generated with donated human cells. This rejuvenated the regenerative potential of ISCs in the mouse and human modeling systems. It also boosted the generation of Paneth and goblet cells and prompted an increase in the number of intestinal crypts and other critical structures.

The scientists are following up the current study by trying to define the extent to which therapeutic intervention to rejuvenate ISCs might be beneficial to humans.

Reference:

Nalapareddy, K., Nattamai, K. J., Kumar, R. S., Karns, R., Wikenheiser-Brokamp, K. A., Sampson, L. L., . . . Geiger, H. (2017). Canonical Wnt Signaling Ameliorates Aging of Intestinal Stem Cells. Cell Reports, 18(11), 2608-2621. doi:10.1016/j.celrep.2017.02.056

This article has been republished frommaterialsprovided by Cincinnati Children's Hospital. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Reversing Aging of Intestinal Stem Cells - Technology Networks

Abstracts: Stem Cells, Selfies, Whales, and More – Undark – Undark Magazine

By Stem Cell Clinic

Unregulated, for-profit stem cell clinics might be the next snake oil salesmen. Three women went blind following injections of stem cells extracted from liposuction treatments in a clinic in Florida. Though they paid for the treatment, they were led to believe that they were participating in a government-approved clinical trial. (New York Times)

Scientists used to think of groups of 10 to 20 humpback whales as large, but groups of up to 200 have been spotted off the coast of South Africa.

Visual by iStock.com/YinYang

Its better to have cystic fibrosis in Canada. More efficient lung transplant allocation, high-fat diets, and ultimately more comprehensive insurance increases the average life expectancy of Canadians living with the genetic disorder. (STAT)

Trumps first budget proposal would include a nearly 20 percent cut to the NIH budget and eliminate the Fogarty International Center, an organization dedicated to building partnerships with health researchers scientists in other countries. (Washington Post)

Humpback whales are also organizing at unprecedented rates. Researchers report huge pods of the usually solitary whales congregating around South Africa at a time of the year when the whales are usually feeding in Antarctica. (Popular Science)

Despite typhoons, rooftop farming and self-grown organic foods are taking off in Hong Kong. (The New Yorker)

A study in the New England Journal of Medicine demonstrates that patient-specific, induced pluripotent stem cells are safe for transplant into eyes, but are still far from effective or affordable. (Science)

NASA released satellite images detailing green slush ice around the Granite Harbor in Antarctica. The presence of so much phytoplankton in an icy region has worrisome implications for algal blooms in the spring. (The Huffington Post)

Startups and health care providers are increasingly looking for ways to standardize the selfie. By providing patients with a color card to include in photos of their urine sample, pregnancy pre-eclampsia and chronic kidney conditions are caught earlier. (The Economist)

In an effort to curb prescription opioid abuse, Endo Pharmaceuticals reformulated Opana into crush-resistance capsules. The new capsules are much easier to dissolve, leading to a rise in injection and subsequent HIV and Hepatitis C outbreaks. An FDA advisory panel concluded risks outweighed the benefits of prescribing Opana. (NPR)

And finally, a look at how the chemistry of how lithium-ion batteries turn into skin-searing firebombs. (Wired)

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Abstracts: Stem Cells, Selfies, Whales, and More - Undark - Undark Magazine

US Stem Cell Inc (OTCMKTS:USRM) Still Looks Like A Winner … – Insider Financial

By Stem Cell Clinic

At the beginning of March, we highlighted US Stem Cell Inc (OTCMKTS:USRM) as being one to watch. The company is a stem cell player in the US, and we argued that its PPS was not accurately reflecting its potential. We linked to this presentation, given by CEO Kristin Comella, and recommended watching as a very concise, but relevant, primer on the companys operations.

Our concern, and the primary risk we associated with the company at this stage, was rooted in opacity surrounding the companys lead quants. Revenue figures were unclear at that point, as was cash holding and burn, and this made it difficult to justify anything more than a punt exposure from a risk reward perspective.

Well, since our coverage, two things have happened. The first, serves to alleviate much of the opacity, and in doing so, mitigates a substantial portion of the risk side of the equation. The second is what markets seem to be paying attention to, and has induced the opposite impact to that which we mightve expected if just the first event hit press.

Heres a look at both factors, and how they play into the companys attraction as a long term exposure going forward.

So, first, the good news.

On March 15, US Stem Cell put out financial results detailing full year 2016, and offered some perspective against the counterpart figures from the same period a year earlier. Based on the numbers, revenues increased from $2.2 million in 2015 to $3.03 million in 2016 a 38% climb. Current liabilities decreased from $8 million to $6 million between end 2015 and end 2016, a 24% decline. Operating expenses decreased, despite a top line increase, by 16.5%. Net loss came in at $1.15 million for 2016, versus $2.6 million a year earlier. Additionally, the company ended the year cash positive, at $108.5K, versus cash negative a year earlier, at $844K.

So, things are moving in the right direction, and weve now got some solid indication of what the company generates annually numbers on which we can start to base some sort of valuation. Things look good, right?

Not so fast.

Heres the second of our developments, and it comes in the form of an article seemingly borne out of the AP, but that is currently doing the rounds across all the major business and healthcare news networks, detailing the blinding of three women on the back of treatment at a stem cell clinic in Florida.

The exact details are unclear, but these women are reported to have been left either blind or partially blind on the back of retinal detachment post therapy and and heres the important part the treatment center they attended is a US Stem Cell center.

Right off the bat, this doesnt look great. In our eyes, however, this is nothing more than a hit piece. The company has conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported. Sure, the piece states this fact, but it does so after basically accusing Comella and her team of blinding three women through unapproved stem cell procedures.

Anyway, whatever the underlying truth (and motive) of the piece, its this, as opposed to the numbers and the companys 99.9% safety record that markets are focusing on. We see this as an opportunity one to get in at a discount ahead of US Stem Cells fortunes reversing and the company revaluing to reflect its true potential as both a company, and a player in the stem cell sector in the US.

With buyout rumors also floating around, and the companys lead clinical asset and technology MyoCell on the verge of FDA fast track designation approval in the US, theres plenty of potential catalysts near term to get this thing moving towards said revaluation.

We will be updating our subscribers as soon as we know more. For the latest updates on USRM, sign up below!

Disclosure: We have no position in USRM and have not been compensated for this article.

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US Stem Cell Inc (OTCMKTS:USRM) Still Looks Like A Winner ... - Insider Financial

Scientists may be close to cure for sickle cell disease – Irish Medical News

By Uncategorized

Paris, France

A world-first procedure, performed at Necker Childrens Hospital, Paris, will offer hope to millions of people suffering with sickle cell blood disorder. Scientists were able to change the genetic instructions in the patients bone marrow so that it could produce healthy red blood cells. At this stage, the therapy has been working for 15 months and the child who was operated on is no longer in need of any medication.

Sickle cell disease is a lifelong condition caused as a result of a faulty gene that affects the manner in which red blood cells develop. Shaped like a sickle, these deformed cells can lock together, blocking blood flow around the body and causing intense pain, as well as organ damage that can be potentially fatal.The patient who received the treatment suffered internal damage to such an extent that his spleen had to be removed and his hips were replaced. In addition, each month he had to have a blood transfusion in hospital in an effort to dilute his defective blood. However, at just 13 years of age his doctors offered him something unique.

They removed his bone marrow and then genetically altered it in a lab so that it would compensate for the defect in his DNA that had caused the disease. The team used a virus to infect the bone marrow with new, correct instructions, which was then put back into the patient. The results, published in the New England Journal of Medicine indicate that the teenager has been able to produce normal blood since the procedure was performed. Philippe Leboulch, a professor of medicine at the University of Paris, told the BBC: So far the patient has no sign of the disease, no pain, no hospitalization.They are excited by the positive results so far, but Prof Leboulch hesitates to use the word cure, as this is only the first patient to have come through their clinical trial. Although the study shows the potential power of gene therapy in transforming the lives of people with sickle cell, the expensive procedure is currently available only in cutting-edge hospitals and laboratories, while the majority of sickle cell patients are found in Africa. The next step will be making this pioneering science available to help millions of people.

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Scientists may be close to cure for sickle cell disease - Irish Medical News

Fat cells step in to help liver during fasting – Medical Xpress – Medical Xpress

By Uncategorized

March 17, 2017 A UT Southwestern study determined that the metabolite uridine helps the body regulate glucose. This graphic depicts how the bodys fat cell-liver-uridine axis works to maintain energy balance. Credit: UT Southwestern Medical Center

How do mammals keep two biologically crucial metabolites in balance during times when they are feeding, sleeping, and fasting? The answer may require rewriting some textbooks.

In a study published today in Science, UT Southwestern Medical Center researchers report that fat cells "have the liver's back," so to speak, to maintain tight regulation of glucose (blood sugar) and uridine, a metabolite the body uses in a range of fundamental processes such as building RNA molecules, properly making proteins, and storing glucose as energy reserves. Their study may have implications for several diseases, including diabetes, cancer, and neurological disorders.

Metabolites are substances produced by a metabolic process, such as glucose generated in the metabolism of complex sugars and starches, or amino acids used in the biosynthesis of proteins.

"Like glucose, every cell in the body needs uridine to stay alive. Glucose is needed for energy, particularly in the brain's neurons. Uridine is a basic building block for a lot of things inside the cell," said Dr. Philipp Scherer, senior author of the study and Director of UT Southwestern's Touchstone Center for Diabetes Research.

"Biology textbooks indicate that the liver produces uridine for the circulatory system," said Dr. Scherer, also Professor of Internal Medicine and Cell Biology. "But what we found is that the liver serves as the primary producer of this metabolite only in the fed state. In the fasted state, the body's fat cells take over the production of uridine."

Basically, this method of uridine production can be viewed as a division of labor. Researchers found that during fasting, the liver is busy producing glucose and so fat cells take over the role of producing uridine for the bloodstream. These findings were replicated in human, mouse, and rat studies.

Although uridine has many roles, this study is the first to report that fat cells produce plasma uridine during fasting and that a fat cell-liver-uridine axis regulates the body's energy balance.

Study lead author Dr. Yingfeng Deng, Assistant Professor of Internal Medicine, found that blood uridine levels go up during fasting and down when feeding. During feeding, the liver reduces uridine levels by secreting uridine into bile, which is transferred to the gallbladder and then sent to the gut, where it helps in the absorption of nutrients.

"It turns out that having uridine in your gut helps you absorb glucose; therefore uridine helps in glucose regulation," Dr. Scherer said.

The uridine in the blood works through the hypothalamus in the brain to affect another tightly regulated system body temperature, Dr. Scherer added. It appears that only uridine made by fat cells reduces body temperature, he said.

Among the study's other key findings:

Blood uridine levels are elevated during fasting and drop rapidly during feeding. Excess uridine is released through the bile.

The liver is the predominant uridine biosynthesis organ, contributing to blood uridine levels in the fed state.

The fat cells dominate uridine biosynthesis and blood levels in the fasted state.

The fasting-induced rise in uridine is linked to a drop in core body temperature driven by a reduction in the metabolic rate.

In dietary studies, the researchers found that prolonged exposure to a high-fat diet blunted the effects of fasting on lowering body temperature, an effect also associated with obesity. Further testing indicated those findings were due to the reduced elevation in uridine in response to fasting, said Dr. Deng, also a member of the Touchstone Diabetes Center.

Future research questions include studying the effects of feeding-induced reductions in uridine levels in organs that rely heavily on uridine from plasma, such as the heart, and whether bariatric surgery affects blood uridine levels.

"Our studies reveal a direct link between temperature regulation and metabolism, indicating that a uridine-centered model of energy balance may pave the way for future studies on uridine balance and how this process is dysregulated in the diabetic state," Dr. Scherer said.

Explore further: Size matters when it comes to keeping blood sugar levels in check

More information: Yingfeng Deng et al. An adipo-biliary-uridine axis that regulates energy homeostasis, Science (2017). DOI: 10.1126/science.aaf5375

How do mammals keep two biologically crucial metabolites in balance during times when they are feeding, sleeping, and fasting? The answer may require rewriting some textbooks.

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Unethical Stem Cell Therapy for Autism In India? – Discover Magazine (blog)

By Uncategorized

I just read a concerning paper about an experimental stem cell treatment for children with autism.

The authors are Himanshu Bansal and colleagues of India. The senior author, Prasad S Koka, is the Editor-in-Chief of the Journal of Stem Cells where the paper appeared, which raises questions about whether the manuscript received a thorough peer review. Koka is actually an author on all five of the research papers published in that issue of the journal. But thats a minor issue compared to the content of the paper.

Bansal et al. describe a procedure in which they extracted fluid from the bone marrow of each child. This fluid (bone marrow aspirate) was treated in the laboratory to purify the stem cells within, and then injected into the childs spinal canal. The whole operation took place under general anaesthesia. 10 autistic children aged 4-12 were treated.

I found this pretty shocking. An invasive procedure involving general anaesthesia should only be performed if its medically justified especially in children as young as 4! Bansal et al. provide no scientific explanation for why they thought this treatment was suitable for these patients. They vaguely name immunological and neural dysregulation believed to underlie autism as the target of the cells.

For what its worth, the results showed a slight improvement in autism symptoms after the treatment. However, there was no control group, so placebo effects are likely, and were told that the patients were also given speech therapy, occupational therapy and psychological intervention which might account for the benefits.

So who gave the green light to this project? Well, remarkably, Bansal et al.s paper contains no information about which ethics committee reviewed and approved the study. I dont know about the laws in India, but in the UK or the USA, conducting even the most benign research without the proper ethical approval is serious misconduct. Most journals absolutely wont publish medical research without an ethics statement.

The paper also contains no mention of conflicts of interest another thing that most medical journals require. I believe that financial conflicts of interest are likely to exist in this case because Bansal gives his affiliations as Mother Cell, his own private venture, and RegennMed, who sell various stem cell treatments.

Overall, to say that this paper is ethically questionable is an understatement, and it would have been rejected by any real journal.

This isnt Dr Himanshu Bansals first foray into the amazing world of dodgy stem-cells. He briefly made headlines around the globe last year when he announced his ReAnima project to bring a brain dead woman back to life (with stem cells). Indian authorities eventually blocked his resurrection attempt. Theres some more interesting dirt on Bansal on this forum.

This is also not the worlds first stem cells for autism trial. For example, Duke University launched a $40 million trial in 2014. The treatment in that trial was a blood infusion, so it was pretty non-invasive: no bone marrow, spinal needles, or general anaesthesia. However, critics argue that its pure speculation to think that stem cells would help in autism. Then again, the same could be said about a great many stem cell therapies.

Bansal H, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. (2016). A Short Study Report on Bone Marrow Aspirate Concentrate Cell Therapy in Ten South Asian Indian Patients with Autism Journal of Stem Cells, 11 (1)

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Unethical Stem Cell Therapy for Autism In India? - Discover Magazine (blog)

Hitachi Chemical Agrees $75M Deal for Caladrius Cell Therapy Manufacturer, PCT – Genetic Engineering & Biotechnology News

By Uncategorized

Caladrius Biosciences is selling the 80.1% stake it retains in its PCT subsidiary to Hitachi Chemical, which already owns the other 19.9% of the cell therapy manufacturing and development services business. Hitachi Chemical has agreed to pay Caladrius $75 million in cash to acquire PCT outright and potentially another $5 million on the achievement by PCT of certain revenue-based milestones. The transaction is expected to close in May, subject to customary closing conditions and the approval of Caladrius shareholders. If ratified, PCT will continue to provide development and manufacturing services to Caladrius for the latters cell therapeutics programs for a period of 7 years after closing.

PCT has more than 130 employees and operates cGMP compliant facilities in the NY/NJ region and in California. The firms Center for Innovation and Engineering offers process and analytical development, engineering solutions, and consulting services. PCT president, Robert A. Preti, Ph.D., said all PCT customers, including Caladrius, will benefit from integration of the firm into Hitachis global engine. Hitachi Chemical intends to deploy the capital and engineering expertise needed to leverage PCTs own engineering and cell therapy development and manufacturing expertise, thereby accelerating the creation of a global commercial manufacturing enterprise.

Caladrius said it will use funds from the PCT sale to support Phase II development of its lead type 1 diabetes (T1D) candidate CLBS03 to eliminate its $5.5 million in debt and to identify new pipeline candidates. Hitachi Chemicals purchase of our remaining interest in PCT unlocks the value of this asset for our Company both by transforming Caladrius into a well-capitalized pure play therapeutics development company and by eliminating our need to contribute the tens of millions of dollars of future capital investment in PCT needed for it to fully realize its cell therapy commercial manufacturing growth goals, said David J. Mazzo, Ph.D., Caladrius CEO. The transaction provides considerable nondilutive capital to fund the execution of our ongoing Phase II trial while also allowing us to exploit compelling therapeutic prospects.

Hitachi took its initial 19.1% stake in PCT in March 2016 as part of a licensing deal and collaboration for PCTs cell therapy manufacturing technology in Japan and parts of Asia.

Cell therapeutics firm Caladrius is exploiting its T-regulatory cell, CD34, and tumor cell/dendritic cell technologies to develop a pipeline of cell therapy candidates for autoimmune and cardiology indications. Lead candidate CLBS03 is an autologous T-regulatory cell therapy in Phase II development for treating recent-onset T1D. The study is partnered with Sanford Research. CLBS03 has been granted Fast Track and Orphan Drug Designation for the T1D indication by the FDA and Advanced Therapeutic Medicinal Product classification by the EMA. In February, Caladrius won up to $12.2 million in funding from the California Institute for Regenerative Medicine (CIRM) to support the CLBS03 development program.

The firms second pipeline product, CLBS12, is a CD34 cell therapy, which Caladrius says it plans to partner for the indication of critical limb ischemia, in Japan, under the countrys regenerative medicine law.

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Hitachi Chemical Agrees $75M Deal for Caladrius Cell Therapy Manufacturer, PCT - Genetic Engineering & Biotechnology News

3 Women Blinded After Stem Cell Therapy – Newser

By Uncategorized

Newser
3 Women Blinded After Stem Cell Therapy
Newser
CORRECTS FROM MD ANDERSON HOSPITAL TO MD ANDERSON CANCER CENTER -Senior Clinical Cell Therapy Specialist Megan Raggio prepares stem cells from bone marrow before they are transplanted into sportscaster... (AP Photo/David J. Phillip).
Stem Cell Therapy Blinds Three Patients at Florida ClinicMedscape
Cutting-edge stem cell therapy proves safe, but will it ever be effective?Science Magazine
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3 Women Blinded After Stem Cell Therapy - Newser

Three People Are Nearly Blind After Getting a Stem Cell Treatment – TIME

By Stem Cell Treatment

Rolando Caponi / EyeEmGetty Images/EyeEm

When doctors give their patients a difficult diagnosis, whether its for a condition like cancer or a rarer disease for which there is no standard treatment, they often refer them to clinicaltrials.gov . The National Institutes of Health and National Library of Medicine provide this web site as a service for people who want to find and participate in trials of experimental treatments. With so many new studies launched every day of promising therapies, it is a helpful resource for both doctors and patients eager to do everything they can to beat their disease.

But a report published in the New England Journal of Medicine highlights the dangers of some experimental trials, even ones listed on a government-supported site. Three women in their 70s and 80s who enrolled in a stem cell trial to treat age-related macular degeneration , caused by deterioration of the most sensitive part of the retina, were left with severe vision loss following the treatment they received in the trial. All three patients found the study, sponsored by BioHeart, Inc., on clinicaltrials.gov.

The women each had liposuction to remove fat tissue, and the fat cells were processed to extract stem cells that they were told would develop into cells that would replace the diseased ones in their eyes.

Instead, the injected solution caused inflammation, infection and detached retinas in all three women. Detached retinas require surgery to repair in order to prevent blindness. Within days of receiving the treatment, all three patients went to the hospital with vision loss, severe infections and bleeding.

BioHeart, now known as U.S. Stem Cell, issued the following statement on the results. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations. Neither U.S. Stem Cell nor U.S. Stem Cell Clinic currently treats eye patients.

The study was conducted in several unusual ways, says Dr. Thomas Albini, from the Bascom Palmer Eye Institute, who was not involved in the trial but treated two of the women after they developed complications. First, all three women had both eyes treated at the same time, which Albini says isn't typical for an untested therapy. When testing something experimental for the eye, doctors usually treat only one eye at a time, in case adverse events occur or the treatment proves too dangerous or toxic to the patient.

He says that the patients only signed what appears to be a one-page surgical consent form for the procedure. The form may have indicated that the procedure they would receive was experimental and had not been approved, but clinical trial consent forms are usually lengthy documents that detail the procedure and the risks and potential benefits involved. The two women told Albini that they did not recall signing documents other than the single page form.

The patients also learned that the trial was being funded by payments they and others made. Each patient who enrolled paid $5,000 to receive the experimental treatment in both eyes, according to the women. The vast majority of legitimate clinical trials do not require payment. In fact, most tests and therapieseven transportation to the facility, in some casesare generally covered by the study.

The unfortunate outcome is a reminder of the burden put on patients to vet trials, even if they appear on clinicaltrials.gov. That may be challenging for people without any medical background, especially since clinicaltrials.gov is maintained by what most believe to be reliable and ethical government health institutes. But the site doesn't vet every trial posted; it performs minimal review of study designs to ensure they are scientifically sound and have received ethical and scientific approval from what are called institutional review boards (IRBs). These boards include both scientific experts as well as ethicists to analyze a study to make sure participants won't be exploited. Without mandatory requirements for such board approvals, any investigator can technically post a trial on the site. And while the Food and Drug Administration (FDA) approves drugs and medical treatments, it doesnt have direct oversight over clinicaltrials.gov. Patients confuse FDA approval of a treatment, which does indicate that a treatment has met certain standards like it has demonstrated efficacy and safety, with just being listed on the web site, says Albini.

The site does state that ClinicalTrials.gov does not independently verify the scientific validity or relevant of the submitted information beyond a limited quality control review for apparent errors, deficiencies or inconsistencies. But, Albini says, the web site could probably do a better job of making that disclaimer more prominent.

Albini says the incident should reinforce to doctors that simply sending their patients to clinicaltrials.gov isnt enough. Patients need help from the medical community or public health officials to navigate sites like these and make sense of the information they find, he says.

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Three People Are Nearly Blind After Getting a Stem Cell Treatment - TIME

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