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Category Archives: Illinois Stem Cells

Immunoglobulin (IG or Immune Globulin or Gamma Globulin)

Posted: November 1, 2015 at 3:46 pm

Immunoglobulin (IG or Immune Globulin or Gamma Globulin)

IgG is pooled/plasma containing antibodies against a number of diseases like measles, rubella, varicella, hepatitis A, etc.

It is given in the following situations:

For passive protection against rubella, measles, chicken pox after exposure in high risk populations e.g. immunocompromised, pregnancy, less than one year of age.

For protection against Hepatitis A after exposure. It must be given within two weeks of exposure and should be given concurrently with Hepatitis A to develop active immunity. A second dose of Hepatitis A is required six months later.

For those traveling to high risk countries who do not have time to develop active immunity before departure (less than four weeks). It should be given concurrently with the first dose of Hepatitis A. A second dose is due six months later.

IG is prepared from pooled plasma through purification and sterilization. It is recommended that travelers take the Hepatitis A vaccine if time permits. IG should be used during pregnancy only when clearly needed.

Side effects after receiving IG may include: muscle stiffness, redness, warmth, pain and tenderness at injection site. Fever, chills, headache, weakness and nausea may occur. If these symptoms continue beyond 48 hours or become bothersome, contact your physician. If skin rash, swelling of hands/feet or face, or trouble breathing develop, contact your doctor immediately.

IG may interfere with the immune response to live vaccines, so discuss this with your physician before taking it. If you take IG, you will not be able to donate blood for several months.

Individuals who have had Hepatitis A disease or who have completed the series of Hepatitis A vaccine have lifetime immunity and do not require IG.

A frequently asked question concerns the difference between IG, which is a passive form of protection, and a vaccine such as Hepatitis A vaccine. IG is manufactured from antibodies and comes from another persons donated plasma. Its called passive because the body of the person receiving IG does not react to the IG but simply circulates it. Thus the recipient is given instant protection. Over a few months, this protection disappears. A vaccine or immunization, or active form of protection, stimulates the recipients immune system to build its own antibodies. The body retains the pattern so that more can be built in the future. This type of response to a vaccine may last several months to a lifetime.

If you are a registered University of Illinois student and you have questions or concerns, or need tomake an appointment, please call: Dial-A-Nurse at 333-2700

If you are concerned about any difference in your treatment plan and the information in this handout,

you are advised to contact your health care provider.

Visit the McKinley Health Center Web site at: http://www.mckinley.illinois.edu

HEd.VIII-003

The Board of Trustees of the University of Illinois, 2006.

09-22-06

immunoglobulin

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Patient-Specific Stem Cells and Personalized Gene Therapy …

Posted: October 2, 2015 at 1:48 pm

Images of normal (above) and diseased retinas. Patients with MFRP mutations, a cause of retinitis pigmentosa, lose the function of most retinal cells, particularly at the periphery of the retina, leaving them with drastically reduced vision. Personalized gene therapy, using iPS cells, may offer a way to correct this genetic disorder. Click here for animated version.(Image credit: Lab of Stephen H. Tsang, MD, PhD/Columbia University Medical Center.)

NEW YORK, NY (July 10, 2014) Columbia University Medical Center (CUMC) researchers have created a way to develop personalized gene therapies for patients with retinitis pigmentosa (RP), a leading cause of vision loss. The approach, the first of its kind, takes advantage of induced pluripotent stem (iPS) cell technology to transform skin cells into retinal cells, which are then used as a patient-specific model for disease study and preclinical testing.

Using this approach, researchers led by Stephen H. Tsang, MD, PhD, showed that a form of RP caused by mutations to the gene MFRP (membrane frizzled-related protein) disrupts the protein that gives retinal cells their structural integrity. They also showed that the effects of these mutations can be reversed with gene therapy. The approach could potentially be used to create personalized therapies for other forms of RP, as well as other genetic diseases. The paper was published recently in the online edition of Molecular Therapy, the official journal of the American Society for Gene & Cell Therapy.

The use of patient-specific cell lines for testing the efficacy of gene therapy to precisely correct a patients genetic deficiency provides yet another tool for advancing the field of personalized medicine, said Dr. Tsang, the Laszlo Z. Bito Associate Professor of Ophthalmology and associate professor of pathology and cell biology.

While RP can begin during infancy, the first symptoms typically emerge in early adulthood, starting with night blindness. As the disease progresses, affected individuals lose peripheral vision. In later stages, RP destroys photoreceptors in the macula, which is responsible for fine central vision. RP is estimated to affect at least 75,000 people in the United States and 1.5 million worldwide.

More than 60 different genes have been linked to RP, making it difficult to develop models to study the disease. Animal models, though useful, have significant limitations because of interspecies differences. Researchers also use human retinal cells from eye banks to study RP. As these cells reflect the end stage of the disease process, however, they reveal little about how the disease develops. There are no human tissue culture models of RP, as it would dangerous to harvest retinal cells from patients. Finally, human embryonic stem cells could be useful in RP research, but they are fraught with ethical, legal, and technical issues.

The use of iPS technology offers a way around these limitations and concerns. Researchers can induce the patients own skin cells to revert to a more basic, embryonic stem celllike state. Such cells are pluripotent, meaning that they can be transformed into specialized cells of various types.

In the current study, the CUMC team used iPS technology to transform skin cells taken from two RP patientseach with a different MFRP mutationinto retinal cells, creating patient-specific models for studying the disease and testing potential therapies.

By analyzing these cells, the researchers found that the primary effect of MFRP mutations is to disrupt the regulation of actin, the protein that makes up the cytoskeleton, the scaffolding that gives the cell its structural integrity. Normally, the cytoskeleton looks like a series of connected hexagons, said Dr. Tsang. If a cell loses this structure, it loses its ability to function.

The researchers also found that MFRP works in tandem with another gene, CTRP5, and that a balance between the two genes is required for normal actin regulation.

In the next phase of the study, the CUMC team used adeno-associated viruses (AAVs) to introduce normal copies of MFRP into the iPS-derived retinal cells, successfully restoring the cells function. The researchers also used gene therapy to rescue mice with RP due to MFRP mutations. According to Dr. Tsang, the mice showed long-term improvement in visual function and restoration of photoreceptor numbers.

This study provides both in vitro and in vivo evidence that vision loss caused by MFRP mutations could potentially be treated through AAV gene therapy, said coauthor Dieter Egli, PhD, an assistant professor of developmental cell biology (in pediatrics) at CUMC, who is also affiliated with the New York Stem Cell Foundation.

Dr. Tsang thinks this approach could also be used to study other forms of RP. Through genome-sequencing studies, hundreds of novel genetic spelling mistakes have been associated with RP, he said. But until now, weve had very few ways to find out whether these actually cause the disease. In principle, iPS cells can help us determine whether these genes do, in fact, cause RP, understand their function, and, ultimately, develop personalized treatments.

In normal, or wild-type, retinal cells (left), the protein actin forms the cells cytoskeleton, creating an internal support structure that looks like a series of connected hexagons. In cells with MFRP mutations (center), this structure fails to form, compromising cellular function. When diseased retinal cells are treated with gene therapy to insert normal copies of MFRP (right), the cells cytoskeleton and function are restored. (Image credit: Lab of Stephen H. Tsang, MD, PhD/Columbia University Medical Center.)

About:

The paper is titled, Gene therapy in patient-specific stem cell lines and a preclinical model of retinitis pigmentosa with membrane frizzled-related protein (MFRP) defects. The other contributors are Yao Li (CUMC), Wen-Hsuan Wu (CUMC), Chun-Wei Hsu (CUMC), Huy V. Nguyen (CUMC), Yi-Ting Tsai (CUMC), Lawrence Chan (CUMC), Takayuki Nagasaki (CUMC), Irene H. Maumenee (Illinois Eye and Ear Infirmary, University of Illinois at Chicago, Chicago, IL), Lawrence A. Yannuzzi (CUMC), Quan V. Hoang (CUMC), and Haiqing Hua (CUMC and NYSCF, New York, NY).

The authors declare no financial or other conflicts of interests.

The study was supported by grants from the National Institute of Health (5P30EY019007, 5P30CA013696, R01EY018213), Research to Prevent Blindness, the Tistou and Charlotte Kerstan Foundation, the Barbara and Donald Jonas Laboratory, the Schneeweiss Stem Cell Fund, New York State (N09G-302, N13G-275), a Foundation Fighting Blindness New York Regional Research Center Grant (C-NY05-0705-0312), the Joel Hoffman Fund, the Gale and Richard Siegel Stem Cell Fund, the Laszlo Bito and Olivia Carino Foundation, the Irma T. Hirschl Charitable Trust, the Bernard and Anne Spitzer Stem Cell Fund, the Professor Gertrude Rothschild Stem Cell Foundation, and the Gebroe Family Foundation.

Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, th
e School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. For more information, visit cumc.columbia.edu or columbiadoctors.org.

CUMC on Twitter:@ColumbiaMed#CUMC CUMC on Facebook

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From stem cells to billions of human insulin-producing …

Posted: October 2, 2015 at 1:47 pm

Harvard stem cell researchers today announced that they have made a giant leap forward in the quest to find a truly effective treatment for type 1 diabetes, a condition that affects an estimated 3 million Americans at a cost of about $15 billion annually:

With human embryonic stem cells as a starting point, the scientists are for the first time able to produce, in the kind of massive quantities needed for cell transplantation and pharmaceutical purposes, human insulin-producing beta cells equivalent in most every way to normally functioning beta cells.

Doug Melton, who led the work and who 23 years ago, when his then infant son Sam was diagnosed with type 1 diabetes, dedicated his career to finding a cure for the disease, said he hopes to have human transplantation trials using the cells to be underway within a few years.

We are now just one pre-clinical step away from the finish line, said Melton, whose daughter Emma also has type 1 diabetes.

A report on the new work has today been published by the journal Cell.

Felicia W. Pagliuca, Jeff Millman, and Mads Gurtler of Meltons lab are co-first authors on the Cell paper. The research group and paper authors include a Harvard undergraduate.

You never know for sure that something like this is going to work until youve tested it numerous ways, said Melton, Harvards Xander University Professor and a Howard Hughes Medical Institute Investigator. Weve given these cells three separate challenges with glucose in mice and theyve responded appropriately; that was really exciting.

It was gratifying to know that we could do something that we always thought was possible, he continued, but many people felt it wouldnt work. If we had shown this was not possible, then I would have had to give up on this whole approach. Now Im really energized.

The stem cell-derived beta cells are presently undergoing trials in animal models, including non-human primates, Melton said.

Elaine Fuchs, the Rebecca C. Lancefield Professor at Rockefeller University, and a Howard Hughes Medical Institute Investigator who is not involved in the work, hailed it as one of the most important advances to date in the stem cell field, and I join the many people throughout the world in applauding my colleague for this remarkable achievement.

For decades, researchers have tried to generate human pancreatic beta cells that could be cultured and passaged long term under conditions where they produce insulin. Melton and his colleagues have now overcome this hurdle and opened the door for drug discovery and transplantation therapy in diabetes, Fuchs said.

And Jose Oberholzer, MD, Associate Professor of Surgery, Endocrinology and Diabetes, and Bioengineering at the University of Illinois at Chicago, and its Director of the Islet and Pancreas Transplant Program and the Chief of the Division of Transplantation, said work described in todays Cell will leave a dent in the history of diabetes. Doug Melton has put in a life-time of hard work in finding a way of generating human islet cells in vitro. He made it. This is a phenomenal accomplishment.

Melton, co-scientific director of the Harvard Stem Cell Institute, and the Universitys Department of Stem Cell and Regenerative Biology both of which were created more than a decade after he began his quest said that when he told his son and daughter they were surprisingly calm. I think like all kids, they always assumed that if I said Id do this, Id do it, he said with a self-deprecating grin.

Type 1 diabetes is an autoimmune metabolic condition in which the body kills off all the pancreatic beta cells that produce the insulin needed for glucose regulation in the body. Thus the final pre-clinical step in the development of a treatment involves protecting from immune system attack the approximately 150 million cells that would have to be transplanted into each patient being treated. Melton is collaborating on the development of an implantation device to protect the cells with Daniel G. Anderson, the Samuel A. Goldblith Professor of Applied Biology, Associate Professor in theDepartment of Chemical Engineering, the Institute of Medical Engineering and Science, and the Koch Institute at MIT.

Melton said that the device Anderson and his colleagues at MIT are currently testing has thus far protected beta cells implanted in mice from immune attack for many months. They are still producing insulin, Melton said.

Cell transplantation as a treatment for diabetes is still essentially experimental, uses cells from cadavers, requires the use of powerful immunosuppressive drugs, and has been available to only a very small number of patients.

MITs Anderson said the new work by Meltons lab is anincrediblyimportant advance for diabetes. There is no question that ability to generate glucose-responsive, human beta cells through controlled differentiation of stem cells will accelerate the development of new therapeutics. In particular, this advance opens to doors toan essentially limitless supply oftissue for diabetic patients awaiting cell therapy."

RichardA.Insel, MD, chief scientific officer of the JDRF, a funder of Meltons work, said the JDRF is thrilled with thisadvancementtoward large scale production of mature, functional human beta cells by Dr. Melton and his team. This significant accomplishmenthas the potentialto serve as a cell source for islet replacement in people with type 1 diabetes and mayprovide a resource for discovery of beta cell therapies that promote survival or regeneration of beta cells and development of screening biomarkers to monitor beta cell health and survival to guidetherapeutic strategies for all stages of the disease.

Melton expressed gratitude to both the Juvenile Diabetes Research Foundation and the Helmsley Charitable Trust, saying their support has been, and continues to be essential. I also need to thank Howard and Stella Heffron, whose faith in our vision got this work underway, and helped get us where we are today.

While diabetics can keep their glucose metabolism under general control by injecting insulin multiple times a day, that does not provide the kind of exquisite fine tuning necessary to properly control metabolism, and that lack of control leads to devastating complications from blindness to loss of limbs.

About 10 percent of the more than 26 million Americans living with type 2 diabetes are also dependent upon insulin injections, and would presumably be candidates for beta cell transplants, Melton said.

There have been previous reports of other labs deriving beta cell types from stem cells, no other group has produced mature beta cells as suitable for use in patients, he said. The biggest hurdle has been to get to glucose sensing, insulin-secreting beta cells, and thats what our group has done.

In addition to the institutions and individual cited above, the work was funded by the Harvard Stem Cell Institute, the National Institutes of Health, and the JPB Foundation.

Cited: Pagliuca, F., Millman, J. and Grtler, M, et. al. Generation of functional human pancreatic beta cells in vitro. Cell. October 9, 2014.

Dr. Melton has made an author's proof available. Click here to download the PDF.

The beginning shows a spinner flask containing red culture media and cells, the cells being too small to see. Inside the flask you can see a magnetic stir bar and the flask is being placed on top of a magnetic stirrer.

This is followed by a time cours
e series of images, magnified, showing how cells tart of as single cells and then grow very quickly into clusters over the next few days. The size of the clusters is the same as the size of human islets at the end.

The final image shows 6 flasks, enough for 6 patients, spinning away. If you look closely, you can see particles spinning around, the white dust or dots are clusters of cells, each containing about 1000 cells.

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Bone Marrow and Stem Cell Transplant | Loyola Medicine

Posted: June 21, 2015 at 2:45 pm

Why Loyola Largest Bone Marrow and Stem Cell Transplant Program in Illinois

Loyola's Bone Marrow and Stem Cell Transplantation Program is the largest transplant program in Illinois, having performed more than 2,900 transplants to date. Our interdisciplinary team of doctors isdedicated to research and improvement of the transplant process, thereby improving patient outcomes and survival rates. Loyola is proud to be a participating transplant, apheresis and collection center in the National Marrow Donor Program network.

Bone marrow is found in the center cavities of all bones and within the ends of the long bones of your arms and legs. Bone marrow is composed of stem cells that give origin to:

The goal of a bone marrow or peripheral (stem cell) transplant is to replace unhealthy stem cells with healthy stem cells, or to replace bone marrow cells that are damaged while treating cancer with high-dose therapy. The new cells from a transplant will cause the bone marrow to function normally again.

Loyola offers a full spectrum of transplant options and is dedicated to maintaining your physical and mental fitness. Our highly skilled transplant team will answer your medical questions and help you through the process. Care is provided by our experienced, interdisciplinary transplant team, which includes attending physicians, an advanced practice nurse, professional nursing staff, dietitians, social workers, chaplains and a clinical psychologist.

Our program is actively involved in research, providing individuals with an opportunity to participate in a variety of clinical trials, including national breast, lymphoma, leukemia, ovarian, testicular and multiple myeloma studies.

Bone marrow transplant is most commonly used to treat leukemia and lymphoma. However, this treatment option can also be used to treat other cancers such as neuroblastoma and multiple myeloma.

The type of transplant you may have is determined by your diagnosis. There are three types of bone marrow transplants:

A bone marrow/stem cell transplant comprisesthree steps, including preparation, transplant and recovery. To start, your doctors will prepare your body for transplant by using chemotherapy or radiation to eliminate the existing unhealthy cells.

Once the preparation is complete, you will undergo the transplant, which is infused very similarly to a blood transfusion. Following the transplant procedure, you will stay in the hospital while your body begins to produce healthy bone marrow and your doctors ensure that the transplant was successful.

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Naperville Illinois Stem Cell Research | Naperville IL …

Posted: June 10, 2015 at 8:49 am

Naperville IL Stem Cell Research is a complex and beneficial science using stem cells in a lab environment to better understand how normal human development works, and also to look for and develop new treatments for a wide range of human ailments. Naperville Illinois Stem Cell Research involves two types of stem cells, classified as either embryonic stem cells or adult stem cells, which are used according to the type of Naperville IL Stem Cell Research that is desired.

Embryonic stem cells are derived from pre-embryos, called blstocysts, approximately three to five days old. They are created specifically for fertilization treatments in the Naperville Illinois Stem Cell Research lab, will not be used to start a pregnancy, and will be discarded if not used for research. Doctors use in-vitro fertilization to create an embryo in a culture dish, which after three to five days becomes a blstocysts. Naperville IL Stem Cell Research lab technicians then extract the inner cell mass from the blstocysts, which is used to derive embryonic stem cells in the Naperville Illinois Stem Cell Research facility.Embryonic stem cells are classified as pluripotent.

This means they can develop into any type of cell in a fully developed human body. It should be noted that embryonic stem cells cant develop into placenta or umbilical cord tissues, but they do appear to be able to develop into any other type of cell in a human body. What is so important about embryonic Naperville IL Stem Cell Research is that it enables very flexible research, as the stem cells can be grown into any type of cell needing to be researched, at any time, at the Naperville Illinois Stem Cell Research facility. This makes for more efficient and more productive stem call research, promising a faster path to cures for ailments that devastate humanity. Naperville IL Stem Cell Research cannot use adult stem cells to generate just any desired tissues since they are already programmed. They are quite useful nonetheless, and Naperville Illinois Stem Cell Research doctors have identified caches of adult stem cells in several tissues of the human body.

Naperville IL Stem Cell Research in general has been able to make some wonderful advancement and create excellent treatments using adult stem cells. But there are limitations to doing Naperville Illinois Stem Cell Research using "only" adult stem cells. Adult stem cells are able to give rise to related kinds of cells in their home tissues, but for example Kidney stem cells cannot generate heart cells, and liver stem cells cannot generate brain cells.

A great deal of Naperville IL Stem Cell Research remains to be done, and at this point Naperville Illinois Stem Cell Research doctors have developed a technique for getting an adult stem cell to behave similar to an embryonic stem cell. This specialized Naperville IL Stem Cell Research technique creates what are called induced pluripotent stem cells (iPS). They can be produced from adult cells in skin, fatty tissue, and other sources. With this, Naperville Illinois Stem Cell Research remains a promising field. There is of course a great deal more work to do, but Naperville IL Stem Cell Research promises to benefit mankind in many profound ways.

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Northwestern Medicine Investigates Using Stem Cells to Save Limbs from Amputation

Posted: April 3, 2015 at 8:00 pm

CHICAGO, April 2, 2015 /PRNewswire-USNewswire/ --After surgery failed to relieve extreme pain caused by peripheral artery disease in her right leg, Denise Hopkins-Glover was facing a bleak outlook she might never walk again.

"They said they had done everything they could and the only option was amputation of the right leg from the knee down," she said.

Undeterred, Hopkins-Glover chose to participate in an investigational trial at Northwestern Medicine called the MOBILE Study, which makes use of a device called the MarrowStim PAD Kit. In the trial, a randomized group of patients receive injections of their own stem cells retrieved through a bone marrow extraction to try to restore blood flow to the leg.

"MarrowStim offers a new approach for patients with a grim prognosis," said principal investigator Melina Kibbe, MD, a vascular surgeon at Northwestern Memorial Hospital and Edward G. Elcock Professor of Surgical Research at Northwestern University Feinberg School of Medicine. "We're pleased to be part of this national trial to see if there might be a significant chance of improving treatment for patients with few choices left for treatment."

Hopkins-Glover, a 55-year-old grandmother of two, suffers from peripheral artery disease (PAD), a condition affecting 20 percent of Americans where cholesterol and fatty plaque pool in blood vessels, restricting blood flow to the limbs. In its most severe form, PAD causes critical limb ischemia (CLI), which can cause pain in resting legs, sores or ulcers that don't heal, thickening of the toenails and gangrene, which can eventually lead to amputation.

The Chicago resident worked as a phlebotomist before her PAD worsened, and had to stop working because she could no longer walk or stand for extended stretches of time.

"I can walk only a certain distance before the circulation stops getting to certain parts of the body," she said. "It feels like a terrible leg cramp, like a jabbing, stabbing pain."

During the procedure, patients are put under general anesthesia as bone marrow is harvested through a needle from the hip. The bone marrow is loaded into the MarrowStim PAD Kit, an investigational device, where it is processed in a centrifuge. This spinning separates the marrow into different layers, with one of the layers containing the stem cells. Immediately following the separation, the stem cells are injected in 40 different spots on the affected limb, delivering concentrated bone marrow in each one. The entire procedure takes about 90 minutes. Patients follow up with investigators at different intervals in the year following the injections.

Karen Ho, MD, a Northwestern Medicine vascular surgeon who is also an investigator on the trial, said the exact reason the bone marrow injections might help chronic limb ischemia is still a mystery.

"Nobody really knows the exact mechanism," said Dr. Ho, who is also an assistant professor in vascular surgery at Feinberg. "The idea is that it might improve or enhance new blood vessels in the calf."

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Cleveland BioLabs Reports Fourth Quarter and Fiscal 2014 Financial Results and Development Progress

Posted: February 27, 2015 at 10:54 pm

Cleveland BioLabs reported a net income for the fourth quarter of 2014 of $11.3 million, or $3.95 per share, compared to a net loss of $0.4 million, or $0.16 per share, for the same period in 2013.Net income for fiscal 2014 was $1.6 million, or $0.60 per share, compared to a net loss of $17.3 million, or $7.67 per share, for the same period in 2013.The increase in net income was primarily attributable to a $14.2 million gain on the deconsolidation of the Company's joint venture, Incuron LLC.Excluding the gain on the deconsolidation of Incuron, net loss per share for the fourth quarter of 2014 was $1.02 and net loss per share for fiscal 2014 was $4.66.

At December 31, 2014, the Company had cash, cash equivalents and short-term investments of $3.1 million, $0.5 million of which was restricted for the use of subsidiaries Panacela Labs, Inc. and BioLab 612, LLC.In addition, on February 6, 2015, the Company closed an equity transaction pursuant to which it received net proceeds of approximately $3.7 million.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "We have made significant progress with all of our development programs over the past few months and believe that 2015 will be an important year for CBLI, as we near potential commercialization for entolimod's biodefense indication and release clinical data bringing validation to our first-in-class oncology assets.The pre-Emergency Use Authorization (pre-EUA) submission for entolimod is on schedule to be filed within the first half of 2015.We are actively engaged with several U.S. government agencies to solicit their input to our pre-EUA dossier, as well as potential funding and procurement support.We recently announced that we received notice that our proposal to support further development of entolimod as a medical radiation countermeasure has been recommended for funding by the Department of Defense office of Congressionally Directed Medical Research Programs.This potential funding is subject to negotiations and availability of funds and relates to our proposal to conduct several pivotal animal efficacy studies required by the U.S. Food and Drug Administration(FDA) for submission of a Biological Licensure Application (BLA)."

"In addition, our oncology drug candidates continue to advance through clinical studies," continued Dr. Kogan."The Phase 1 study of entolimod in advanced cancer patients at Roswell Park Cancer Institute has been completed and the findings have been submitted for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO), which will be held from May 29 - June 2 in Chicago, Illinois.Preliminary evaluations of the study indicate that the tolerability profile in patients with advanced cancer was similar to that observed in two previously conducted studies in 150 healthy volunteers and initial assessments of immunological response were consistent with activation of toll-like receptor 5 (TLR5), the drug's target.Early analyses also indicate that stable disease was observed in several patients with heavily pretreated cancers.These observations confirm our preclinical findings and support the hypothesis that entolimod has potential as an immunotherapeutic agent.We have initiated a follow-on study in Moscow, Russia intended to extend the clinical observations from the higher entolimod dose levels evaluated in the Roswell Park trial.This follow-on study is supported by a matching-funds development contract from the Ministry of Industry and Trade of the Russian Federation (MPT)."

"Incuron's two ongoing clinical studies evaluating oral and intravenous administrations of Curaxin CBL0137 in patients with advanced solid tumors are recruiting patients to the ninth and seventh dose-escalation cohorts, respectively.In January, we disclosed that a formal interim analysis of the 19 patients enrolled in the first six cohorts of the ongoing oral administration study indicated that the study medication was well tolerated at all investigated dose levels.The observation of drug exposure in plasma documented high oral bioavailability (typically estimated to be greater than or equal to 50%).To date, no dose-limiting toxicities have been observed with either oral or intravenous administration through the highest CBL0137 dose levels tested.Heavily pretreated patients with advanced cancers of the esophagus, colon, breast, cervix, and prostate have had stable disease for periods ranging from 4 to 6 months.Peripheral blood mononuclear cells (PBMC) from evaluable blood samples have shown pharmacodynamic effects consistent with the expected mechanism of action of CBL0137.These initial results are encouraging, and Incuron plans to initiate a multicenter study of CBL0137 in patients with hematological malignancies in 2015."

"Finally, the Phase 1 healthy subject study of CBLB612, a drug candidate in development for the induction and mobilization of hematopoietic stem cells (HSCs) continues.In addition to evaluating safety, tolerability and pharmacology of a single administration of CBLB612, this study has been designed to characterize the type, quantity and timing of HSC mobilization in these subjects.We look forward to sharing continued progress with our drug candidates as more clinical data becomes available."

Further Financial Highlights

Revenue for the fourth quarter of 2014 decreased to $1.4 million compared to $3.9 million for the fourth quarter of 2013.Revenue for fiscal 2014 decreased to $3.7 million compared to $8.5 million for the same period in 2013.These decreases were primarily the result of the completion of contracts with the Department of Defense for entolimod's biodefense indication and variances in the levels of development activity under other contracts with MPT.

Research and development costs for the fourth quarter of 2014 decreased to $2.8 million compared to $4.6 million for the same period in 2013.Research and development costs for fiscal 2014 decreased to $9.7 million compared to $19.5 million for the same period in fiscal 2013.These decreases were primarily due to completion of third-party service contracts for several compounds in-line with and largely in support of the contracted development work discussed above, as well as reduced compensation costs in-line with our reduced workforce.

General and administrative costs for the fourth quarter of 2014 decreased to $2.0 million compared to $2.3 million for the same period in 2013.General and administrative costs for fiscal 2014 decreased to $8.5 million compared to $12.0 million for the same period in 2013.For the year, $2.2 million of these decreases were due to reduction in personnel and consultants.

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Regenexx Stem Cell Treatments and Platelet Procedures …

Posted: February 16, 2015 at 7:54 am

The Regenexx Family of Advanced Regenerative Medicine Procedures offer breakthrough, non-surgical treatment options for individuals suffering from joint or bone pain, torn or strained tendons / ligaments or other common injuries as well as degenerative conditions. Regenexx procedures offer viable alternatives for patients with chronic pain who may be considering surgery.

Stem cells and platelet-derived growth factors are in all of us and they are responsible for healing injured bone, cartilage, ligaments, tendons and other tissues. They are the key components behind the Regenexx Procedures. As we get older or injured, we sometimes cannot get enough of these cells into the area to heal. The Regenexx Procedures help solve this problem by precisely delivering a high concentration of stem cells and platelets into the injured area, aiding your bodys ability to heal naturally. Patients experience very little down time and they typically avoid the long, painful rehabilitation periods that often follow surgery to restore joint strength and mobility.

The Regenexx-SD procedure begins when the doctor thoroughly numbs the back of the hip (PSIS) and takes a small bone marrow sample through a needle, as well as a blood draw from a vein in the arm. The marrow is rich in Mesenchymal Stem Cells, which are responsible for healing damaged tissues. The stems cells are isolated from the marrow sample and platelets are isolated from the blood sample. After preparation, these two components will be reinjected directly into the damaged area of the joint using advanced imaging guidance. This ensures the cells are delivered to the exact location of need.

Have you been diagnosed with one the following:

If any of these apply to your condition, please complete the Regenexx Candidate Form to take the next steps in evaluating whether youre a candidate for treatment.

Regenexx Procedures were recently featured on The Doctors TV show. The episode featured Dr. Christopher J. Centeno and Dr. Ron Hanson from the Centeno-Schultz Clinic in Colorado, along with patient Barbee James, who sought stem cell treatment following traditional knee surgery. The 6 minute video provides a nice overview of the Regenexx-SD (Same Day) Stem Cell procedure, which is now offered at our clinic.

If you are suffering from a joint injury, joint pain or a non-healing fracture, you may be a good candidate for this ground-breaking treatment. Please complete the Procedure Candidate Form below and we will get back to you with more information after your form is received.

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Regenexx Stem Cell Treatments and Platelet Procedures ...

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Students envision future cities with skyscraper farms

Posted: January 18, 2015 at 10:54 am

Middle school students from Maryland, Virginia and Washington gathered Saturday in Baltimore to present their visions of future cities capable of feeding themselves with urban farms.

A team from the Edlin School in Reston, Va., bounced out of the Baltimore Museum of Industry carrying first-place trophies and big smiles after judges bestowed the top prize on their imaginary city, Fortuna. A team from Garrison Forest School in Owings Mills won second place with their city, Esperanza. And Agriville, the city built by Immaculate Heart of Mary School in Towson, landed the students' choice award.

The Future City competition is sponsored by DiscoverE, an engineering advocacy organization. The theme for this year's event was "Feeding Future Cities," which challenged students to grow one protein food and one vegetable in urban settings.

Teams from 19 schools in the organization's Mid-Atlantic region have been working since September to write 1,000-word essays about their cities, craft computer simulations and build large-scale models using budgets of $100.

The Reston, Va., team's victory landed it a spot in the national competition in Washington, scheduled for Feb. 15-18. The team used a 3D printer to produce biodegradable plastic pieces that made up the bulk of the buildings they used for their model. The team, led by student Rayyan Khan, 14, devised a concept to grow food in labs using stem cells from chicken and kale.

"The hard work paid off," said Shaila Khan, the team's adviser.

The Garrison Forest School squad "grew soy beans in vertical farms" in skyscrapers and salmon in fish hatcheries, said Serena Shafer, 13.

The Immaculate Heart of Mary School's team envisioned an Illinois city on the shores of Lake Michigan called Agriville, said Abby Slovick, 13. The model featured farming inside skyscrapers and hydroponic facilities to grow crops year round, Slovick said.

The model also featured an "edible park" of apples, pears and cherries, said Darby Brandenburg, 13. And the city's power was generated by two windmills, including a 2,000-foot-tall represented in the model by a standing electric toothbrush, said Aysia Davis, 12.

The two foods the Towson team decided were best for future sustainability are not typically counted among children's favorites: spinach and soybeans.

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Students envision future cities with skyscraper farms

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Live imaging captures how blood stem cells take root in the body

Posted: January 16, 2015 at 5:52 am

17 hours ago Blood stem cell en route to taking root in a zebrafish. Credit: Boston Children's Hospital

A see-through zebrafish and enhanced imaging provide the first direct glimpse of how blood stem cells take root in the body to generate blood. Reporting online in the journal Cell today, researchers in Boston Children's Hospital's Stem Cell Research Program describe a surprisingly dynamic system that offers several clues for improving bone marrow transplants in patients with cancer, severe immune deficiencies and blood disorders, and for helping those transplants "take."

The steps are detailed in an animation narrated by senior investigator Leonard Zon, MD, director of the Stem Cell Research Program (see below).

"The same process occurs during a bone marrow transplant as occurs in the body naturally," says Zon. "Our direct visualization gives us a series of steps to target, and in theory we can look for drugs that affect every step of that process."

"Stem cell and bone marrow transplants are still very much a black boxcells are introduced into a patient and later on we can measure recovery of their blood system, but what happens in between can't be seen," says Owen Tamplin, PhD, the paper's co-first author. "Now we have a system where we can actually watch that middle step. "

The blood system's origins

It had already been known that blood stem cells bud off from cells in the aorta, then circulate in the body until they find a "niche" where they're prepped for their future job creating blood for the body. For the first time, the researchers reveal how this niche forms, using time-lapse imaging of naturally transparent zebrafish embryos and a genetic trick that tagged the stem cells green.

On arrival in its niche (in the zebrafish, this is in the tail), the newborn blood stem cell attaches itself to the blood vessel wall. There, chemical signals prompt it to squeeze itself through the wall and into a space just outside the blood vessel.

This video is not supported by your browser at this time.

"In that space, a lot of cells begin to interact with it," says Zon. Nearby endothelial (blood-vessel) cells wrap themselves around it: "We think that is the beginning of making a stem cell happy in its niche, like a mother cuddling a baby."

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Live imaging captures how blood stem cells take root in the body

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