Stem Cell Clinic

Two Day FDA’s Regulation of Regenerative Medicine Seminar … – Business Wire (press release)

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering & Gene Therapies: 2-Day In-person Seminar" conference to their offering.

Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.

This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

Learning Objectives:

Fundamentals of stem cells

- What is all the excitement about

- How to control stem cell differentiation

- Sources of stem cells

- Incorporating stem cells into biomaterials

- Avoiding immune system clearance of stem cells

FDA regulatory approvals for the use of stem cells in medicine

- Currently approved use of stem cells in medicine

- FDA guidance documents for stem cell technologies

- Global approval of stem cell technologies

- How the FDA regulates regenerative treatments and therapies

- The use of human cells, tissues, and cellular and tissue-based product criteria and Minimal Manipulation Standard

- The drug and biological approval process

- Regenerative products as medical devices

- How to design appropriate clinical trials

- Applicable good manufacturing and good laboratory practices

- Product labeling, marketing and advertising

- FDA and other federal agency enforcement action

Future thoughts on approaches for regulatory approval of stem cell technologies

- Remaining hurdles

- Outlook for new technologies

For more information about this conference visit http://www.researchandmarkets.com/research/ljt255/fdas_regulation

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Two Day FDA's Regulation of Regenerative Medicine Seminar ... - Business Wire (press release)

Scientists find skin cells at the root of balding, gray hair – Medical Xpress

May 8, 2017 by Carol Marie Cropper Strand of human hair at 200x magnification. Credit: Jan Homann/Wikipedia

UT Southwestern Medical Center researchers have identified the cells that directly give rise to hair as well as the mechanism that causes hair to turn gray findings that could one day help identify possible treatments for balding and hair graying.

"Although this project was started in an effort to understand how certain kinds of tumors form, we ended up learning why hair turns gray and discovering the identity of the cell that directly gives rise to hair," said Dr. Lu Le, Associate Professor of Dermatology with the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern. "With this knowledge, we hope in the future to create a topical compound or to safely deliver the necessary gene to hair follicles to correct these cosmetic problems."

The researchers found that a protein called KROX20, more commonly associated with nerve development, in this case turns on in skin cells that become the hair shaft. These hair precursor, or progenitor, cells then produce a protein called stem cell factor (SCF) that the researchers showed is essential for hair pigmentation.

When they deleted the SCF gene in the hair progenitor cells in mouse models, the animal's hair turned white. When they deleted the KROX20-producing cells, no hair grew and the mice became bald, according to the study.

The findings are published online in Genes & Development.

Dr. Le, who holds the Thomas L. Shields, M.D. Professorship in Dermatology, said he and his researchers serendipitously uncovered this explanation for balding and hair graying while studying a disorder called Neurofibromatosis Type 1, a rare genetic disease that causes tumors to grow on nerves.

Scientists already knew that stem cells contained in a bulge area of hair follicles are involved in making hair and that SCF is important for pigmented cells, said Dr. Le, a member of the Hamon Center for Regenerative Science and Medicine.

What they did not know in detail is what happens after those stem cells move down to the base, or bulb, of hair follicles and which cells in the hair follicles produce SCF or that cells involved in hair shaft creation make the KROX20 protein, he said.

If cells with functioning KROX20 and SCF are present, they move up from the bulb, interact with pigment-producing melanocyte cells, and grow into pigmented hairs.

But without SCF, the hair in mouse models was gray, and then turned white with age, according to the study. Without KROX20-producing cells, no hair grew, the study said.

UT Southwestern researchers will now try to find out if the KROX20 in cells and the SCF gene stop working properly as people age, leading to the graying and hair thinning seen in older people as well as in male pattern baldness, Dr. Le said.

The research also could provide answers about why we age in general as hair graying and hair loss are among the first signs of aging.

Explore further: New research provides clues on why hair turns gray

More information: Chung-Ping Liao et al. Identification of hair shaft progenitors that create a niche for hair pigmentation, Genes & Development (2017). DOI: 10.1101/gad.298703.117

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Scientists find skin cells at the root of balding, gray hair - Medical Xpress

Reprogrammed Cells Improve Heart Function After a Heart Attack – Medical News Bulletin

In a recent study published in Circulation, researchers managed to convert de-differentiated human fibroblasts, support cells key in healing, to red blood cells or cells that line the interiors of blood vessels via manipulation of the SOX17 transcription factor. The de-differentiated fibroblasts can improve heart function after a heart attack and provide patient-specific cells that do not suffer from premature aging.

Fibroblasts, a support cell key in healing, are commonly used for de-differentiation. De-differentiated cells are similar to stem cells; depending on the environment they are in and what genes are active, they become different cells. De-differentiated cells have many medical uses; as many as the number of cells that they can become. In a recent study published in Circulation, researchers from the University of Illinois College of Medicine and the Indiana University School of Medicine managed to convert de-differentiated human fibroblasts to endothelial cells and erythroblasts. Endothelial cells are the cells that make up the lining of the interior of blood vessels. Erythroblasts are commonly known as red blood cells.

The researchers first de-differentiated the fibroblasts by overexpression of the proteins that transcribe DNA into RNA, specifically, pluripotency transcription factors. The de-differentiated cells were then placed into different media to transform them into endothelial cells and erythroblasts. The researchers observed that a specific transcriptional regulator, SOX17, and its respective activity corresponded to which cell the de-differentiated fibroblasts became. The researchers also experimented on rats that had suffered heart attacks. They implanted the de-differentiated fibroblasts into the rats and found that they improved heart function after a heart attack. Finally, the researchers observed that the cells generated from the de-differentiated fibroblast had increased production of telomerase. Telomerase is a transcription factor that produces telomeres, which are at the ends of chromosomes. The length of telomeres corresponds to the age of a cell, with longer being younger.

All this research shows the power of de-differentiated cells. De-differentiated fibroblasts can make patient-specific cells. These cells may avoid premature aging because of the increased production of telomerase: Helpful for enabling older patients to have personalized cells. Though only shown in mice, the de-differentiated fibroblasts did improve cardiac function after their heart attacks and may benefit humans as well. Pinpointing SOX17 as the switch for making endothelial cells or erythroblasts will optimize their generation, which will prove valuable for tissue regeneration and disease modeling.

Written By:Brian Jones

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Reprogrammed Cells Improve Heart Function After a Heart Attack - Medical News Bulletin

Researchers use modified insulin and red blood cells to regulate blood sugar – Medical Xpress

May 8, 2017 by Matt Shipman Credit: North Carolina State University

Researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a new technique that uses modified insulin and red blood cells to create a glucose-responsive "smart" insulin delivery system. In an animal model study, the new technique effectively reduced blood sugar levels for 48 hours in a strain of mice that had Type 1 diabetes.

The researchers modified insulin by chemically binding it to a glucose derivative called glucosamine. The glucosamine could then bind to glucose transporters on the surface of a red blood cell, effectively attaching the insulin to the blood cell. The end result is a red blood cell studded with insulin molecules.

The idea is that these insulin-loaded blood cells could then be injected into a diabetic patient. In this study, the work was done in Type 1 diabetic mice.

Once in the bloodstream, the blood cells carrying insulin interact with their environment. If glucose levels are high, glucose molecules effectively displace the glucosamine in the blood cells' glucose transporters. And when the glucosamine is set free from the blood cell, so is the insulin.

The insulin can then bind to insulin receptors in the liver, muscles and fatty tissues, triggering a process that reduces glucose levels in the blood.

"In short, this is a fully biocompatible smart system that responds, when needed, to normalize glucose levels in the blood," says Zhen Gu, co-corresponding author of a paper on the work and an associate professor in the joint biomedical engineering program at NC State and UNC.

In the study, researchers compared mice receiving the modified insulin and blood cell system to three other groups: a group that received saline solution; a group that got only modified insulin; and a group that got a mixture of unmodified insulin and red blood cells.

The researchers found that the Type I diabetic mice that received the modified insulin and blood cell system were able to significantly reduce blood glucose levels for more than two days. The best performance among the other groups saw an initial dip in blood sugar levels, but returned to high glucose levels within 12 hours.

The researchers also tested each of the drug combinations in a group of healthy mice, and found that the modified insulin and blood cell system reduced the risk of hypoglycemia compared to the other drug combinations.

In addition, the researchers conducted an experiment in the Type I diabetic mice using modified insulin and nanoparticles that had been coated with red blood cell membranes. The modified insulin and nanoparticle system achieved comparable results to those found using modified insulin and red blood cells.

"This is a positive result, because it bodes well for developing a standardized means of delivering this glucose regulation system," Gu says.

"The team will further evaluate the long-term biocompatibility of the modified insulin system in an animal model before determining whether to move to clinical trials," says co-author Dr. John Buse, professor of medicine at the UNC School of Medicine and director of the UNC Diabetes Care Center and the NC Translational and Clinical Sciences Institute. "The vision, if realized, would be one of the most exciting advances in diabetes care."

"We are also exploring the use of painless microneedles to deliver this system, rather than relying on the conventional injections which were used in this study," Gu says. "The possibility of using a different drug delivery system makes it difficult to assess cost, but we're optimistic that the cost of the potential formulation would be comparable to existing treatments."

The paper, "Red Blood Cells for Glucose-Responsive Insulin Delivery," is published in the journal Advanced Materials. Lead author of the paper is Chao Wang, a postdoctoral researcher in Gu's research group. The paper was co-authored by Yanqi Ye, Wujin Sun and Jicheng Yu, Ph.D. students in Gu's group; Jingqiang Wang, a postdoctoral researcher in Gu's group; and David Lawrence of UNC.

Explore further: Post-biotics may help shield obese from diabetes

More information: Chao Wang et al, Red Blood Cells for Glucose-Responsive Insulin Delivery, Advanced Materials (2017). DOI: 10.1002/adma.201606617

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Researchers use modified insulin and red blood cells to regulate blood sugar - Medical Xpress

Fixing broken hearts through tissue engineering – Science Daily

Fixing broken hearts through tissue engineering Science Daily Cardiac progenitor cells that can contribute to growth or repair injury in the heart were only discovered in 2003, says symposium presenter Michael Davis, Ph.D., associate professor of Medicine, Department of Biomedical Engineering, Georgia Tech ...

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Fixing broken hearts through tissue engineering - Science Daily

Aspirin Prevents Platelets from Suppressing Anticancer T Cells – Genetic Engineering & Biotechnology News (blog)

Platelets do more than promote clotting. They weaken one of the bodys immune defenses against cancer. Unfortunately, platelets tend to work against the immuno-oncology treatments that try to strengthen T-cell attacks on cancer.

Platelets, new research indicates, suppress T-cell immunity against cancer by expressing a transmembrane protein, the glycoprotein A repetitions predominant (GARP) receptor. Platelet GARP can snag a growth factor, transforming growth factor- (TGF), and thereby promote cancer. When GARP binds with TGF, the latter can become activated and then convert effector T cells, which normally attack cancer with an inflammatory reaction, into regulatory (suppressor) T cells, which turn off the inflammatory reaction.

The new findings appeared May 5 in the journal Science Immunology, in an article entitled Platelets Subvert T Cell Immunity against Cancer via GARP-TGF Axis. This study expands on earlier findings that indicated platelets, in cancer-associated thrombocytosis, might make cancer worse.

An unbiased biochemical and structural biology approach established TGF and lactate as major platelet-derived soluble factors to obliterate CD4+ and CD8+ T cell functions, wrote the articles authors. Moreover, we found that platelets are the dominant source of functional TGF systemically as well as in the tumor microenvironment through constitutive expression of the TGF-docking receptor GARP rather than secretion of TGF per se.

Scientists have known for several years that certain cancers suppress T cells to avoid the immune system. That is why adoptive T-cell therapy is one of the most promising advances in modern cancer treatment. It is a type of immunotherapy that awakens the immune system by retraining a patient's T cells to recognize their cancer. T cells are isolated from a patient's blood and retrained, or "primed," to recognize tumor cells. They are then injected back into the patient's bloodstream where they can now hunt and fight cancer.

In the current study, scientists have shown that genetic targeting of platelets enhances adoptive T-cell therapy of cancer. Platelet-specific deletion of the GARP-encoding gene Lrrc32, the authors of the Science Immunology article indicated, blunted TGF activity at the tumor site and potentiated protective immunity against both melanoma and colon cancer.

This work, which was carried out by scientists based at the Medical University of South Carolina, revealed the mechanism behind platelets activation of TGF. The scientists showed that in genetically modified mice without GARP, the molecular hook on the surface of platelets, adoptive T-cell therapy was more successful at controlling melanoma. This meant that platelets without the ability to grab and activate TGF were not able to suppress cancer-fighting T cells. Similar experiments confirmed this result in mice with colon carcinoma.

Finally, mice with normal platelets that were given melanoma and then adoptive T-cell therapy survived longer and relapsed less when aspirin and clopidogrel, two antiplatelet drugs, were added. The researchers noted that antiplatelet drugs by themselves were not successful in combating melanoma in their experiments.

This study could inform future treatment of melanoma and other cancers and offers a sound reason to test antiplatelet drugs in clinical trials of adoptive T-cell therapy. In patients with melanoma or other cancers, adoptive T-cell therapy may be successful if highly available platelet-blocking drugs such as aspirin are added to the treatment. However, the current standard of care for melanoma is not adoptive T-cell therapy, but rather so-called checkpoint inhibitors.

The team at the Medical University of South Carolina, which was led by Zihai Li, M.D., Ph.D., want to know if combination therapy with antiplatelet drugs could improve existing cancer treatment. They are waiting for approval to begin a clinical trial that will test certain checkpoint inhibitors in combination with aspirin and clopidogrel for the treatment of patients with advanced cancers. Dr. Li's trial will complement clinical trials that are already testing adoptive T-cell therapy as a single treatment for cancer.

"I'm very excited about this," said Dr. Li. "We can test simple, over-the-counter antiplatelet agents to really improve immunity and make a difference in how to treat people with cancer."

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Aspirin Prevents Platelets from Suppressing Anticancer T Cells - Genetic Engineering & Biotechnology News (blog)

Presidential Symposium at the American Society of Gene and Cell Therapy (ASGCT) 20th Annual Meeting Will Feature … – Yahoo Finance

FREMONT, Calif., May 3, 2017 /PRNewswire/ --Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that data from its AST-OPC1 clinical program for severe cervical spinal cord injury will be presented during the Presidential Symposium at the American Society of Gene and Cell Therapy (ASGCT) 20th Annual Meeting, being held in Washington, D.C. during May 10-13, 2017.

"The ASGCT decision to include a presentation on AST-OPC1 in its Presidential Symposium signifies the ground-breaking nature of our program, and reflects the encouraging efficacy and safety data we have seen to date in patients with severe spinal cord injuries that have been treated with AST-OPC1," said Steve Cartt, President and Chief Executive Officer of Asterias. "Data will be presented from our SCiStar study demonstrating the potential of AST-OPC1 to help patients with complete paralysis regain increased arm, hand and finger function, and thus greater ability to live independently."

Jane S. Lebkowski, Ph.D., Asterias' President of R&D and Chief Scientific Officer, will be one of the presenters during the Presidential Symposium session scheduled on Friday, May 12, 2017 at 1:00pm Eastern Time. Dr. Lebkowski's presentation, titled "498 - Safety and Efficacy of Human Embryonic Stem Cell Derived Oligodendrocyte Progenitor Cells (AST-OPC1) in Patients with Subacute Cervical Spinal Cord Injury," is expected to begin at 2:15pm Eastern Time. The abstract for Dr. Lebkowski's presentation at the ASGCT meeting is available online at: http://www.abstractsonline.com/pp8/#!/4399/presentation/1996.

ASGCT is the primary professional membership organization for gene and cell therapy. The Society's members are scientists, physicians, patient advocates, and other professionals. Its members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies. Its mission is to advance knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at http://www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

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In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries, which represents the first targeted population for registration trials.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at http://www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

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

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/presidential-symposium-at-the-american-society-of-gene-and-cell-therapy-asgct-20th-annual-meeting-will-feature-presentation-on-asterias-ast-opc1-for-spinal-cord-injury-300450272.html

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Presidential Symposium at the American Society of Gene and Cell Therapy (ASGCT) 20th Annual Meeting Will Feature ... - Yahoo Finance