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Category Archives: Cell Therapy

My husband’s heart failure inspired life-saving stem cell therapy – Telegraph.co.uk

Posted: May 8, 2017 at 7:44 am

Its our goal for this to be a normal NHS procedure, so everyone who has a heart problem [and could benefit from this] will be able to. There are few downsides because theres no rejection as theyre your own stem cells, and every patient who has successfully had this treatment ends up taking less medication.

Jenifer is overjoyed with the progress already made, and knows that Ian would be, too, had he lived to tell his story.

For Ian, the treatment gave him an extra three years of life, but in 2006 he died from heart failure, at the age of 70.

He would be so thrilled, says Jenifer. His concern would be were not doing it quick enough, because for him everything had to be done immediately. But to have achieved this much well, the medical world says weve done it all in a very short space of time.

The couple spent their final years together alternating between their family home in St Johns Wood, north London, and a holiday home in Miami.

They were both each others second spouses, having married in 1980 after a whirlwind romance in Cannes Jenifers first husband had died, while Ian had divorced his wife and did not have children together. But Ian had two children from his first marriage, as well as two young grandchildren who he was able to spend those extra three years with.

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My husband's heart failure inspired life-saving stem cell therapy - Telegraph.co.uk

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CAR T Cells: Keeping Pace With Adverse Effects of an Emerging Therapy – Oncology Nurse Advisor

Posted: May 7, 2017 at 9:41 am


Oncology Nurse Advisor
CAR T Cells: Keeping Pace With Adverse Effects of an Emerging Therapy
Oncology Nurse Advisor
Chimeric antigen receptor T cells (CAR T cells) are human T cells that are collected from the patient and genetically modified to express a CAR immunoreceptor. The modified CAR T cells target specific surface proteins on cancer cells. CAR T cell ...

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CAR T Cells: Keeping Pace With Adverse Effects of an Emerging Therapy - Oncology Nurse Advisor

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

Posted: May 7, 2017 at 9:41 am

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

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Presidential Symposium at the American Society of Gene and Cell … – PR Newswire (press release)

Posted: May 6, 2017 at 3:45 pm

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.

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

SOURCE Asterias Biotherapeutics, Inc.

http://www.asteriasbiotherapeutics.com

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Presidential Symposium at the American Society of Gene and Cell ... - PR Newswire (press release)

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Platelets suppress T cell immunity against cancer – Medical Xpress – Medical Xpress

Posted: May 5, 2017 at 11:43 pm

May 5, 2017 Stylized illustration of a platelet and T cell. Plus and negative signs are used to symbolically indicate the positive (clotting) and negative (downregulating T cell immunity) effects of platelets. Credit: Emma Vought of the Medical University of South Carolina.

Blood platelets help disguise cancer from the immune system by suppressing T cells, report scientists at the Medical University of South Carolina (MUSC) in the May 5, 2017 issue of Science Immunology. In extensive preclinical tests, a promising T cell therapy more successfully boosted immunity against melanoma when common antiplatelet drugs such as aspirin were added.

Zihai Li, M.D., Ph.D., senior author on the article, is chair of the MUSC Department of Microbiology and Immunology, the program leader for the Cancer Immunology Research Program at MUSC Hollings Cancer Center, and the SmartState Sally Abney Rose Chair in Stem Cell Biology & Therapy. Li studies how tumors hide themselves from the immune system.

Li's team found that platelets release a molecule that suppresses the activity of cancer-fighting T cells. That molecule, unsurprisingly, was TGF-beta, which has been recognized for decades for its role in cancer growth.

Yet this study is the first of its kind. Most TGF-beta is inactive. Li and his group found that the surface of platelets has a protein called GARP, a molecular hook that is uniquely able to trap and activate TGF-beta. Platelets, which are small cell fragments that circulate throughout the blood and are normally involved in clotting, become the major source of activated TGF-beta that invading tumor cells use to suppress T cells. In other words, platelets help give tumors their invisibility cloak from the immune system.

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.

There was some evidence that platelets might make cancer worse. For example, patients who have excessive clotting related to their cancer almost always have a worse prognosis, according to Li.

"Over the years, it has become appreciated that platelets are doing more than just clotting," says Li.

The first clue that cancer-fighting T cells might be suppressed by the body's own clotting system came when the researchers gave melanoma to mice with genetically defective platelets. Melanoma tumors grew much more slowly and primed T cells were much more active than in mice with normal platelets.

Next, the team isolated platelets and T cells from blood drawn from humans and mice. In both cases, platelets with activated clotting activity suppressed T cell response. It then used mass spectrometry to thoroughly identify the molecules released by activated platelets that most suppressed T cell activity. The molecule with the most T cell suppression was TGF-beta.

Li and his team then studied how platelets activate TGF-beta. 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-beta 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 so-called checkpoint inhibitors.

Li and his group 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. 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," says 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."

Explore further: Aspirin slows growth of colon, pancreatic tumor cells

More information: "Platelets subvert T cell immunity against cancer via GARP-TGF axis," Science Immunology (2017). immunology.sciencemag.org/lookup/doi/10.1126/sciimmunol.aai7911

Researchers from Oregon Health and Science University and Oregon State University have found that aspirin may slow the spread of some types of colon and pancreatic cancer cells. The paper is published in the American Journal ...

The molecule CD103 is key to the long-term residence of T cells in the skin and to their anti-tumor function, report a team of researchers at the Medical University of South Carolina (MUSC) and the Dartmouth-Hitchcock Norris ...

Metastasis of cancer cells to sites distant from the primary tumor is the leading cause of cancer-related death, and there is growing evidence that platelets aid the dissemination of cancer cells.

In an article published online ahead of print on March 13, 2017 by the Journal of Clinical Investigation, Medical University of South Carolina (MUSC) investigators report preclinical research showing that moesin, a membrane-domain ...

Scientists at the Medical University of South Carolina (MUSC) have designed an antibody-based therapy that could target the functions of TGF-beta that cause cancer. The therapy targets TGF-beta where it is particularly dangerousdocked ...

After surgery to remove a cancerous tumoreven if the surgery is considered "successful"it's nearly impossible to ensure that all microtumors have been removed from the surgical site. Cancer recurrence is always a major ...

Blood platelets help disguise cancer from the immune system by suppressing T cells, report scientists at the Medical University of South Carolina (MUSC) in the May 5, 2017 issue of Science Immunology. In extensive preclinical ...

Phthalates, which are used as plasticizers in plastics, can considerably increase the risk of allergies among children. This was demonstrated by UFZ researchers in conjunction with scientists from the University of Leipzig ...

A new research study of immune responses to pneumococcal vaccines, commonly given to people with compromised immune systems, young children and people over 65, has identified a type of immune cell which is important in generating ...

The findings have implications for all aspects of medical and scientific research because laboratory mice underpin studies whose results have a transformative effect on human and animal lives through vaccination and other ...

A diet supplemented with soy protein may be an effective adjunct therapy for inflammatory bowel diseases, Penn State researchers reported after completing a study that included mice and cultured human colon cells.

Inside a healthy gut, bacteria and immune cells maintain a delicate balance. If that balance is disturbed, a condition called inflammatory bowel disease or IBD can result. Patients with IBD can experience diarrhea, abdominal ...

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Platelets suppress T cell immunity against cancer - Medical Xpress - Medical Xpress

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Presidential Symposium at the American Society of Gene and Cell … – Yahoo Finance

Posted: May 3, 2017 at 8:44 pm

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.

Read More

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 ... - Yahoo Finance

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Cellular Biomedicine Group: A Transpacific Cell Therapy Company – Investing.com

Posted: May 2, 2017 at 1:44 pm

Cellular Biomedicine Group (NASDAQ:) has seven preclinical CAR-T programs and two Phase I clinical trials using its CD19 CAR-T therapy in China, making it the only US-traded CAR-T company in this market. It has rights to the Dendristim lung cancer vaccine. In addition, it is adapting its osteoarthritis (OA) treatment ReJoin as an allogeneic product, AlloJoin, which will be developed in the US after an IND in 2017 or 2018.

Chinese CAR-T trials ongoing

The company has two ongoing Phase I studies using its CD19 CAR-T therapy for the treatment of diffuse large B-cell lymphoma (DLBCL) and adult acute lymphoblastic leukemia (ALL). None of the major CAR-T developers currently running trials in the US and Europe have initiated studies in China, positioning CBMG as an early entrant into the market. Data are expected for the trials in Q417.

AlloJoin: Off-the-shelf OA cell therapy

AlloJoin is a cell line derived from human adipose-derived mesenchymal progenitor cells. The companys autologous version of these cells (ReJoin) previously showed improvement in cartilage growth (p=0.007) in patients with knee OA in an early clinical trial. CBMG is developing AlloJoin as an off-the-shelf version of this product and received a grant of $2.29m from the California Institute for Regenerative Medicine to support US development. The interim results from the Phase I trial (n=18) reported no serious adverse events and the most common adverse events were pain (77%) and swelling (52%). The trial is expected to be complete in Q317.

Chinese GMP cell production

One of the unique strengths of the company is its efficient manufacturing. It has three GMP-certified facilities in China, with significantly improved production costs compared to US facilities. CBMG estimates it can provide 10,000 doses of cells per year for the Chinese market (export of human cells from China is highly restricted). This capacity has recently attracted a partnership with GE Healthcare Life Science China to develop control processes for cell manufacturing.

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Cellular Biomedicine Group: A Transpacific Cell Therapy Company - Investing.com

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Cell Therapy Company Joins Forces with Biotech in New Transplantation Research Alliance – Pharmaceutical Processing

Posted: May 2, 2017 at 1:44 pm

Be The Match BioTherapies announces collaboration agreement with Magenta Therapeutics.

MINNEAPOLIS, May 2, 2017 Be The Match BioTherapiesSM, an organization offering solutions for delivering autologous and allogeneic cellular therapies, today announced that it has entered into a strategic partnership with Magenta Therapeutics, a biotechnology company developing therapies to improve and expand the use of curative stem cell transplantation. The collaboration is intended to support efforts to improve transplant outcomes and expand the application of stem cell transplantation into disease indications that include autoimmunity, serious inherited immune and metabolic disorders, blood defects and blood cancers. Be The Match BioTherapies also announced today that it is participating in Magentas Series B financing round, its first equity investment as an organization.

Under the terms of the collaboration agreement, Be The Match BioTherapies and Magenta will explore opportunities to work together across Magentas discovery, clinical development and product delivery efforts. The collaboration leverages a wide range of Be The Match BioTherapies research assets and services, including the National Marrow Donor Program(NMDP)/Be The Match marrow registry, the largest in the world with nearly 16 million volunteer marrow donors. Magenta may also collaborate with Be The Match BioTherapies in the design of clinical trials and of its cell therapy delivery platform and services.

Partnering with Magenta in its efforts to revolutionize the current state of stem cell transplantation aligns with our core mission to help organizations deliver cellular therapies that save more lives and improve the quality of life for patients, said Amy Ronneberg, President of Be The Match BioTherapies. Our collaboration with Magenta exemplifies how cell and gene therapy companies can benefit from our robust network of products and services regardless of where they are in the development life cycle. We look forward to lending our expertise in cellular therapy and leveraging our deep-rooted relationships, partnerships and global infrastructure to support the development of powerful treatment options with great potential to improve patient outcomes in a range of disease areas.

Jason Gardner, D. Phil., Chief Executive Officer, President, and Cofounder of Magenta, added: We believe that Be The Match BioTherapies extensive experience and network in stem cell transplant medicine, coupled with Magentas work in patient conditioning and stem cell harvesting and growth, could accelerate our development path and ability to positively impact patients lives.

Be The Match BioTherapies launched in 2016 as a subsidiary of NMDP/Be The Match, the national organization with a 30-year history of connecting patients with their donor match for a life-saving bone marrow or umbilical cord blood transplant. As experts in providing services and expertise to organizations pursuing life-saving treatments in the cellular therapy space, Be The Match BioTherapies aims to help critically ill patients who can benefit from these treatments.

(Source:Business Wire)

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Cell Therapy Company Joins Forces with Biotech in New Transplantation Research Alliance - Pharmaceutical Processing

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Stem cell therapy ‘magic’ for stroke, eye ailments – Vanguard News – Vanguard

Posted: May 1, 2017 at 4:41 am

By David Ikudayisi

In recently published papers in the New England Journal of Medicine about the use of Stem Cell Therapy for Macular Degeneration, one report showed that 3 partially blind women became blind after the treatment with stem cells and the other report showed that an inevitable loss of vision was halted by use of stem cells in another patient. The stem cells used in these two reports were from two different sources fat and skin cells.

First of all, we need to remember or understand that Macular Degeneration is caused by the deterioration of the central portion of the retina, known as the macula, and it is responsible for focusing central vision in the eye, and it controls our ability to read, drive a car, recognize faces or colors, and see objects in fine detail. In America, it affects more than 10 million people more than cataracts and glaucoma combined.

Caucasians are more likely to develop the disease than African-Americans, Hispanics/Latinos or Africans. At present, Macular Degeneration is considered an incurable eye disease, and the closest hope for cure seems to be via Stem Cell Therapy. As shown in the reports, there is still a lot to be understood about stem cells in terms of dosing, frequency, source to be used for different disorders, etc; especially when talking about very sensitive organs of the body like the eyes.

The Florida Company that treated the three patients that went from partial blindness to total blindness have treated over 7,000 patients and have had very few adverse events reported. The scientific director of the company believes the safety track record is very strong and feels very confident about the procedures that they do as it has shown great success in many different health problems.

However, the rarity of the procedure causing harm draws me to see the many benefits and potential Adult Stem Cell Therapy could have on people. Examples of its effectiveness has been seen in so many patients in different studies and even in my own practice in the United States of America. There are already beneficiaries of Adult Stem Cell Therapy in Nigeria. I can say that my experience using stem cells have been great.

In fact, of all the patients that I have treated, only one did not respond positively after just 1 treatment. This was not even done with Adult Stem Cell Therapy but Platelet Rich Plasma (PRP) Therapy using the patients own blood. Nevertheless, there was no adverse event. The patient is recommended to do Adult Stem Cell Therapy which will increase his chance of success. Many of the other patients showed improvements after the first treatment, and the few that needed second treatment went on to see amazing results after more treatment was done; needless to say that they were elated with the results.

Generally, Adult Stem Cell Therapy and Platelet Rich Plasma Therapy are safe as shown by many published research reports and clinical trials done already. However, this does not guarantee that adverse effects cant occur as seen in the case of the 3 women who had accelerated blindness 2 years ago (as with any other treatments in the scope of medicine).

Another recent report in March 2017 from Medical College of Georgia at Augusta University in USA highlighted one of the benefits of Adult Stem Cell Therapy in stroke patients. The multicenter trial shows that not only was it safe, but if Adult Stem Cell Therapy is given within two days of an ischemic stroke, it could reduce the death of cells around the strokes core that were also injured. The Nigerian government should get involved more and invest more in Regenerative Medicine as it will help improve the health status of the nation.

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Stem cell therapy 'magic' for stroke, eye ailments - Vanguard News - Vanguard

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AJ Foyt undergoes stem cell therapy, toe surgery – USA TODAY

Posted: April 29, 2017 at 5:50 pm


USA TODAY
AJ Foyt undergoes stem cell therapy, toe surgery
USA TODAY
Foyt, whose list of injuries is almost as long as that of his legendary racing achievements, had right foot toe surgery Wednesday just days after stem cell therapy in Mexico. So the winner of Phoenix Raceway's debut event in 1964 won't be at ...

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AJ Foyt undergoes stem cell therapy, toe surgery - USA TODAY

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