Category Archives: Cell Therapy

NEW YORK, March 27, 2017 /PRNewswire/ -- The "Cell Therapy Manufacturing Market, 2017-2027" report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options.

The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand.

Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.

During the course of our study, we identified over 110 organizations that are actively involved in the manufacturing of cell therapies.

The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of cells manufactured, purpose of production (fulfilling in-house requirements / as a contract service provider) and the type of organization (industry / non-industry).

Most active regions in terms of cell therapy manufacturing with schematic representations of world maps that clearly highlight the global cell therapy manufacturing hubs.

Roadmaps published by different agencies across the globe to provide strategies to advance cell therapy manufacturing.

Elaborate profiles of key players that offer contract manufacturing services (industry and non-industry) or manufacture cell therapies in-house; each profile covers an overview of the company, information on its manufacturing facilities, and recent collaborations.

Partnerships that have taken place in the recent past covering manufacturing and services agreements, agreements specific to technology / instruments / process developments, and mergers and acquisitions.

A discussion on the key enablers of the market and challenges associated with the cell therapy manufacturing process.

Potential future growth of the cell therapy manufacturing market segmented by the type of cell therapy, source of cells (autologous and allogeneic) and purpose of manufacturing (in-house and contract services). For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in number of clinical studies, patient population, anticipated adoption of commercial cell-therapies and expected variation in manufacturing costs.

We have provided an estimate of the size of the market in the short to mid-term and long term for the period 2017 to 2027. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutics and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base, and optimistic tracks of the market's evolution.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth.

Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Tim Oldham (CEO, Cell Therapies), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi), Dr. Gerard J Bos (CEO, CiMaas).

Example Highlights

Overall, we identified over 60 industry players and 50 academic institutes / non-profit organizations that are actively contributing in the field of cell-therapy manufacturing. We came across 68 players that are involved in manufacturing of immunotherapies and 66 players that possess capabilities for manufacturing adult stem cell therapies. Further, 28 organizations have facilities for both immunotherapies and adult stem cell therapies. Within the stem cell therapy market, we identified 15 and 17 organizations that are involved in the manufacturing of ESCs and iPSCs, respectively.

As majority of cell therapy products are in early phase of development, several manufacturers have facilities that meet the clinical scale production requirements. However, some players (31, as per our research) have developed / are developing commercial scale capacity for cell therapy production. Examples include (in alphabetical order) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, CELLforCURE, Cognate BioServices, EUFETS, Guy's and St Thomas' Facility, Lonza, MaSTherCell, PharmaCell and WuXi AppTec.

Although the current market landscape is dominated by contract manufacturers, some well-established cell therapy developers have set up in-house manufacturing capabilities to support their requirements of cGMP grade cells. Examples include (in alphabetical order) Adaptimmune, Argos Therapeutics, Cell Medica, Cellular Biomedicine Group, Juno Therapeutics, Kite Pharma and SOTIO. In addition, we identified over 10 organizations that manufacture cell-based therapies for their own clinical research as well as offer contract services to other organizations Examples include (in alphabetical order) Amsterdam BioTherapeutics Unit (AmBTU), apceth Biopharma, Children's GMP / GMP facility (St. Jude Children's Research Hospital), Cook Myosite, John Goldmann Centre for Cellular Therapy (Imperial College London), MolMed, and PCT (a Caladrius Company).

North America has the maximum number of cell therapy manufacturing facilities (~ 43%), followed by the EU where ~40% of the global cell therapy manufacturing facilities are located. Specifically, in the EU, maximum number of manufacturing facilities are located in the UK (~44%). Other emerging pockets for cell therapy manufacturing include Australia, China, Japan, Singapore, South Korea and Israel; facilities in these regions primarily cater to the Asia-Pacific markets.

Over 140 collaborations have been inked between cell therapy developers, cell therapy manufacturers and other stakeholders of the industry. The motive behind the partnerships varies; they have been signed for obtaining manufacturing services, gaining access to services related to data management, reagent supply and logistics, upgrading technologies for manufacturing processes, and acquisition of manufacturing facilities.

The near-term demand for manufacturing of cell-based therapies will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage therapies (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for cell therapy manufacturing to grow at an annualized growth rate of ~42% over the course of next ten years and be worth over USD 4 billion in 2027.

Research MethodologyThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:- Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Industry analysts' views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

Chapter Outlines

Chapter 2 is an executive summary of the insights captured in our report. The summary offers a high level view on the current state of the cell therapy manufacturing market and its likely evolution over the coming decade.

Chapter 3 provides a general introduction to the cell-based therapies and ATMPs, their classification and definitions. It includes a detailed discussion on manufacturing of cell-based therapies, associated challenges, and application of the currently available for cell therapies. The chapter also provides a detailed description on the regulatory landscape for cell therapies.

Chapter 4 identifies the contract service providers / in-house manufacturers that are actively involved in the manufacturing of ATMPs. It provides details on the ATMP manufacturing capabilities of these organizations, specifically focusing on the type of organization, geographic location of their facilities, scale of operation, type of cells manufactured and the purpose of manufacturing (in-house requirement / third party manufacturing). It contains world maps highlighting the geographical locations of cell therapy manufacturing facilities. Further, it discusses the development trends within the overall cell therapy manufacturing landscape.

Chapter 5 provides details on the roadmaps published by different organizations in various geographies, specifically in the US. These roadmaps describe the strategies that are helpful in accelerating the translation from laboratory to clinics.

Chapter 6 contains detailed profiles of in-house manufacturers. Each profile provides a brief overview of the company, its financial performance, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.

Chapter 7 contains detailed profiles of key industrial contract manufacturers that have clinical and / or commercial scale manufacturing capacities. Each profile provides a brief overview of the company, details on manufacturing capabilities and facilities, and the relevant collaborations that have been inked over the last few years.

Chapter 8 contains detailed profiles of key academic players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on manufacturing capabilities and facilities.

Chapter 9 discusses the role of non-profit organizations in advancing cellular therapies. It provides a list of prominent organizations and profiles of key organizations in different regions. Additionally, the chapter provides information of international / national societies that help in disseminating knowledge about the advancement of these therapies in the community.

Chapter 10 features a comprehensive analysis of the collaborations and partnerships that have been forged between the players in this market. It includes a brief description on the various types of partnership models that are employed by stakeholders in this domain. We have categorized the deals / agreements, which have been captured during our research, into different models and have provided analysis on trend of partnerships over time.

Chapter 11 presents a ten year forecast to highlight the likely growth of the cell therapy manufacturing market. We have segregated the financial opportunity by type of cell therapy (T-cell immunotherapy, cell-based cancer vaccines, stem cell therapies and other ATMPs) and the source of cells (autologous and allogeneic). All our predictions are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.

Chapter 12 provides a SWOT analysis capturing the key elements and factors that are likely to influence the market's future.

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.

Chapter 14 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development of different types of cell therapies. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 15 is a collection of interview transcripts of the discussions held with key stakeholders in the industry.

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 17 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.

SummaryThe use of live cells for therapeutic purposes can be traced back to 1968, when patients were first successfully treated with allogeneic human hematopoietic stem cell transplants. This practice has now become an integral part of clinical procedures in the space of bone marrow regeneration and organ transplantation. Cell-based therapies are an emerging segment of the overall biopharmaceutical industry.

Post the approval of first cell-based therapy, Carticel, in 1997 in the US, the field has rapidly advanced and a number of such therapies are currently under development. Given the personalized nature of these treatment options, they are highly specific and hold the potential to address unmet medical needs associated with the treatment of several disorders. The promising therapeutic potential has led many pharmaceutical companies and investors to put in a significant amount of capital towards the development and commercialization of these therapies.

Popular examples of approved cell-based therapies include (in order of their year of approval) Carticel, CreaVax-RCC, JACE, ReliNethra, PROVENGE and Prochymal. In addition, over 500 cell-based therapy candidates are currently in different stages of clinical development; these are being evaluated in over 1,000 active clinical studies in various regions across the globe. The growing number of cell therapy candidates, coupled with their rapid progression through the various phases of clinical development, continues to create an increasing demand for facilities that offer manufacturing services for these therapies.

The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industry players as well as academic institutes are significantly contributing to the production of GMP grade cell types. In addition, the market has witnessed the entry of several players that offer novel technology solutions, aimed at improving and upgrading existing cell-based therapies and their manufacturing processes. We have observed that such players have signed multiple partnerships / collaborations with an aim to optimize, scale-up and expand the capabilities for production of cell-based therapies.

Looking at the evolutionary trends, we believe that the cell therapy manufacturing market will continue to be steadily driven in the mid to long term by expansion of existing manufacturing facilities and establishment of new dedicated facilities. Technological advancements to mitigate challenges posed by conventional methods of production will act as a key enabler to this growth.

Read the full report: http://www.reportlinker.com/p04796888-summary/view-report.html

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Cell Therapy Manufacturing Market, 2017-2027 - Yahoo Finance - Yahoo Finance

March 27, 2017 Obstruction of the lumen of a bronchiole by mucoid exudate, goblet cell metaplasia, and epithelial basement membrane thickening in a person with asthma. Credit: Yale Rosen/Wikipedia/CC BY-SA 2.0

The incidence of asthma is increasing steadily, especially in developed countries. One of the reasons given for this rise is excessive levels of hygiene. Epidemiological studies have, indeed, shown that exposure to a so-called "non-hygienic" environment, rich in microbes, plays a protective role against the development of allergies, including asthma. Conversely, an excessively hygienic environment predisposes children to asthma, although the reasons are not known. In allergic reactions such as asthma, the immune system does not function properly and overreacts to harmful allergens present in the environment (pollens, mites, etc.).

In an article published in Immunity, researchers at the University of Lige show that exposure to bacterial DNA (one of the microbial compounds) drastically amplifies a population of pulmonary macrophages and makes them strongly immunosuppressive, which prevents and treats asthma in mice. This discovery offers promising prospects for the development of a cell therapy based on the administration of these regulatory macrophages to asthmatic patients.

Led by Professor Fabrice Bureau (Ordinary Professorand Welbio Investigator - Walloon Excellence in Life Sciences and Biotechnology) and Dr. Thomas Marichal (Research Associate of the F.R.S.-FNRS), both researchers at the GIGA-University of Lige, the scientific team has discovered how a non-hygienic environment, rich in bacterial DNA, helps to protect against asthma. Notably, synthetic compounds mimicking bacterial DNA have been tested in other studies in humans for their therapeutic effect in the treatment of asthma, but until now, none of these compounds have been approved on the market. This may be due to their toxicity or the lack of basic knowledge about their mechanisms of action. Now, the mechanisms of action have been identified, and this study could allow a cell therapy approach that would avoid the use of potentially toxic compounds.

In this study in mice, researchers first looked at how exposure to microbial compounds (such as bacterial wall components, or their own DNA), or whole microbes modifies the immune environment of the lung. They found that bacterial DNA, unlike the other compounds, was able to strongly amplify a population of so-called interstitial macrophages, and that this expansion persisted for several months in the individual.

Surprisingly, if these same macrophages were isolated from a mouse and re-injected into the lungs of a naive recipient mouse, the individual was not capable of developing asthma against house dust mite extracts. Similarly, if these macrophages were transferred to an asthmatic mouse, the asthmatic mouse was cured and no more symptoms of asthma were present. Based on these results, the researchers now envision developing macrophages with similar properties in vitro from monocytes, a white blood cell type found in human blood.

"If it is possible to create a suppressive macrophage from blood monocytes of asthmatic patients, it is quite conceivable to reinject these macrophages into the lungs of these same patients during routine bronchoscopy procedures performed by pneumologists here at the CHU Lige, and to evaluate the therapeutic potential of these cells," concludes Prof. Fabrice Bureau.

Explore further: Scientists discover peptide that could reduce the incidence of RSV-related asthma

More information: "Bacterial CpG-DNA protects against asthma by expanding lung interstitial regulatory macrophages from local and splenic reservoir monocytes." Immunity, 2017.

Journal reference: Immunity

Provided by: University de Liege

A research report published in the Journal of Leukocyte Biology shows that it may one-day be possible to reduce the incidence of asthma related to infection with respiratory syncytial virus (RSV). Specifically, the researchers ...

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Scientists at the Immunology Frontier Research Center (IFReC) at Osaka University, Japan, have pinpointed specific molecular events that could explain allergic reactions to air pollution. These findings provide a new therapeutic ...

The incidence of asthma is increasing steadily, especially in developed countries. One of the reasons given for this rise is excessive levels of hygiene. Epidemiological studies have, indeed, shown that exposure to a so-called ...

The University of Virginia School of Medicine has again shown that a part of the body thought to be disconnected from the immune system actually interacts with it, and that discovery helps explain cases of male infertility, ...

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Cell therapy approach could lead to novel treatments for asthma - Medical Xpress

Medscape

Stem cells shown to restore erection capability in men with erectile dysfunction Science Daily In recent years several groups have worked to develop stem cell therapy as a cure for erectile dysfunction, but until now the improvements have not been sufficient to allow affected men to achieve full sexual intercourse. Results presented at the ... Just ONE injection of stem cells from a man's stomach could be a permanent cure for impotence (and even help them to ...Daily Mail Scientists find cure for erectile dysfunction would you do THIS for better erections?Daily Star Erections Restored With Fat Cells After ProstatectomyMedscape Medical Daily all 8 news articles »

Excerpt from:
Stem cells shown to restore erection capability in men with erectile dysfunction - Science Daily

Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic Offer Stem Cell Therapy for Pets P&T Community COUNCIL BLUFFS, Iowa, March 26, 2017 (GLOBE NEWSWIRE) -- MediVet stem cell therapy, offered at Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic, provides pets and owners with a way to address health concerns in cats and dogs. and more »

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Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic Offer Stem Cell Therapy for Pets - P&T Community

Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

The US off-shoot of Japanese firm Hitachi Chemical has entered an agreement to up its position in cell therapy contract development and manufacturing organisation (CDMO) PCT by buying out majority shareholder Caladrius Biosciences for a total of $75m in a deal expected to close in May.

Im delighted to report the entry into an agreement for the acquisition of our remaining 80.1% interest in PCT by Hitachi Chemical, Caladrius CEO David Mazzo said on a conference call to discuss his firms Q4 results this week. This transaction has the potential to unlock the tremendous value of our PCT asset in a way that was unimaginable just a few years ago.

He explained Caladrius has been increasingly challenged by the tens of millions of dollars of additional capital investment need over the next several years for PCT to fully realise its cell therapy commercial manufacturing growth goals, and added Hitachi is in a position to deploy the capital and engineering capabilities needed to achieve these.

Caladrius will continue to use PCT for the manufacturing and development of its own cell therapy candidates including CLBS03, a T-regulatory (Treg) cell-based therapy for the treatment of type 1 diabetes mellitus without the burden of having to try to support and grow that business due to the very, very large capital needs necessary to remain competitive, he told stakeholders.

The deal will include the transfer to Hitachi of cGMP-compliant facilities in Allendale, New Jersey and Mountain View, California offering quality systems, streamlined technology transfer, storage and logistics, and cell and tissue processing services.

In a statement following the announced acquisition, PCT said: Our relationship with our clients does not change based on this announcement, nor will it change based on the finalization of this transaction.

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Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT' - BioPharma-Reporter.com

Early results of a clinical trial suggest that stem cell therapy may be a promising treatment for erectile dysfunction, after the procedure was found to restore sexual function in men with the condition.

The stem cell therapy involves injecting the patients' own stem cells - derived from abdominal fat cells - into the erectile tissue of the penis.

Lead researcher Dr. Martha Haahr, of Odense University Hospital in Denmark, and colleagues found that within 6 months of the procedure, 8 of the 21 men treated were able to engage in spontaneous sexual intercourse.

The researchers recently presented their findings at EAU17 - the European Association of Urology's annual conference - held in London in the United Kingdom.

Erectile dysfunction (ED) is a condition whereby a man has difficulties getting or maintaining an erection in order to engage in sexual intercourse.

According to the National Institute of Diabetes and Digestive Kidney Diseases, around 12 percent of men under the age of 60, and 22 percent of men aged between 60 and 69, have ED.

High blood pressure, diabetes, heart disease, chronic kidney disease, and prostate surgery are some of the physical conditions that can cause ED. Psychological issues - such as anxiety, stress, depression, and low self-esteem - can also contribute to ED.

Current treatments for ED include PDE5 inhibitors (such as Viagra), penile implants, and injections. However, Dr. Haahr and team note that all of these therapies can have significant side effects.

As a result, researchers are on the hunt for alternative treatments for ED, and stem cell therapy has emerged as a promising candidate in animal trials.

In their phase I trial, Dr. Haahr and colleagues tested stem cell therapy on 21 men who had ED as a result of undergoing radical prostatectomy for prostate cancer. None of the men had responded to standard medical treatment for ED.

For the stem cell procedure, abdominal fat cells were extracted from each man through liposuction. Stem cells were then isolated from the fat cells and injected into the corpus cavernosum of the penis - the spongy tissue that normally becomes filled with blood during an erection.

Before the stem cell procedure and 6 and 12 months after, the participants' erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire. An IIEF score of 5-7 represents severe erectile dysfunction, 12-16 is mild to moderate erectile dysfunction, and 22-25 is no erectile dysfunction.

All 21 men saw their erectile function improve with stem cell therapy: their IIEF score increased from 6 prior to treatment to 12 at 6 months after treatment.

Eight of the men reported that they had been able to engage in spontaneous sexual activity 6 months after stem cell therapy, and this outcome remained evident at 12 months after treatment. These men saw their IIEF score rise from 7 to 14 with stem cell therapy.

"What we have done establishes that this technique can lead to men recovering a spontaneous erection - in other words, without the use of other medicines, injections, or implants," says Dr. Haahr.

Although the study findings are preliminary, the team says that they show promise for stem cell therapy as an effective treatment strategy for ED.

"We are the first to use a man's own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse," says Dr. Haahr.

"We are pleased with the preliminary outcomes, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 12 months follow-up, indicating that this might be a long-term solution.

This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. But we need to remember that this is a small trial, with no control group. We're still some time away from a clinically available solution."

Dr. Martha Haahr

The researchers are now in the process of initiating a phase II trial to further investigate the safety and efficacy of stem cell therapy for ED.

Learn how eating more fruits could help to lower the risk of ED.

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Erectile dysfunction: Stem cell therapy restores sexual function in phase I trial - Medical News Today

DUARTE>> Dozens of doctors, scientists, businesses and others gathered at City of Hope Thursday for the second California Institute for Regenerative Medicine (CIRM), Alpha Stem Cell Clinics symposium.

CIRM, the states stem cell agency, has developed a network of Alpha Stem Cell Clinics that focus on innovative stem cell-based therapies. The network of three clinics are located at City of Hope, University of California, San Diego, and UCLA/UC Irvine campuses.

The event served as a way for clinics to share their most recent advancements and successes in stem cell therapy clinical trials, and even hear directly from patients who benefited from some of the trials.

We want to review the trials, but we also want to see what other questions we should be asking, said Dr. John Zaia, the Aaron Miller and Edith Miller Chair in Gene Therapy, and director of the Center for Gene Therapy and principal investigator of City of Hopes Alpha Stem Cell Clinic. How will insurance companies charge or pay for these treatments? How do companies plan to develop these treatments? The symposium provides an opportunity to think about these other aspects.

There were also panel speakers who offered more of a motivational talk, such as Pat Furlong, founding president of Parent Project Muscular Dystrophy, discussing how to remove stakeholder barriers to stem cell therapy treatment.

Furlong had to become her and her sons own advocate when they were diagnosed with Duchenne Muscular Dystrophy at a young age. She found there was no standard of care for the disease and no studies or trials in progress to find a treatment, let alone a cure.

Families just didnt know the questions to ask, she said. At the time, few people cared about rare diseases.

After years of no real hope and losing her sons at 15 and 17 years old, with her and her groups persistence, Furlong said there are now 40 companies researching the disease and millions of dollars have gone into research specifically for Duchenne.

City of Hopes Dr. Behnam Badie, chief of neurosurgery and director of the Brain Tumor Program, and Christine Brown, Ph.D., Heritage Provider Network Professor in Immunotherapy and associate director of the T Cell Therapeutics Research Laboratory, discussed their recent successful treatment of a patient with recurrent multifocal glioblastoma using CAR-T cell therapy.

The case study for this unique type of immunotherapy on the most aggressive form of brain cancer was published in the Dec. 29 edition of the New England Journal of Medicine.

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In the Phase I clinical trial, the patient, who did not respond to other types of therapy including radiation and even developed tumors in his brain and spinal cord, was treated with his own genetically modified chimeric antigen receptor (CAR) T cells, injected directly into the tumor and through the ventricular system. The patient experienced remission over 8 months.

City of Hope is one of a few cancer centers in the nation offering studies in CAR-T cell therapy, and is the only cancer center investigating CAR-T cells targeting the specific receptors more common in a majority of glioblastomas.

Dr. Badie and Brown noted that working with CIRM has been instrumental in helping them along with their trial, and not just the funding.

You cant create a good trial without studying the product, said Brown. These are expensive trials. We have to treat these patients and understand what is going on.

Originally posted here:
Symposium discusses latest and future of stem cell therapy - The Pasadena Star-News

Researchers found that along with reducing inflammation in the lung, Mesenchymal stem cell therapy also resulted in significant improvements in lung structure, suggesting that this form of treatment has the potential to repair the damaged lung.

Stem cell therapy may potentially reduce lung inflammation in patients suffering from chronic obstructive pulmonary disease (COPD) and cystic fibrosis, a new study conducted on mice suggests.

Researchers from Queens University Belfast in the UK investigated the effectiveness of Mesenchymal stem cell (MSC) therapy in a mouse model of chronic inflammatory lung disease, which reflects some of the essential features of diseases such as COPD and cystic fibrosis.

They delivered stem cells intravenously to mice at four and six weeks of age, before collecting sample tissue and cells from the lungs at about eight weeks.

These findings were compared to a control group that did not receive the MSC therapy. The results showed that inflammation was significantly reduced in the group receiving MSC therapy.

Cell count for both monocytic cells and neutrophils - signs of inflammation - were significantly reduced after MSC therapy, researchers said.

Analysis of lung tissue revealed a reduction in the mean linear intercept and other measures of lung destruction in MSC treated mice.

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Researchers found that along with reducing inflammation in the lung, MSC therapy also resulted in significant improvements in lung structure, suggesting that this form of treatment has the potential to repair the damaged lung.

These preliminary findings demonstrate the potential effectiveness of MSC treatment as a means of repairing the damage caused by chronic lung diseases such as COPD, said Declan Doherty of Queens University Belfast.

The ability to counteract inflammation in the lungs by utilising the combined anti-inflammatory and reparative properties of MSCs could potentially reduce the inflammatory response in individuals with chronic lung disease whilst also restoring lung function in these patients, Doherty added.

Lung damage caused by chronic inflammation in conditions such as COPD and cystic fibrosis leads to reduced lung function and eventually respiratory failure.

MSC therapy is currently being investigated as a promising therapeutic approach for a number of incurable, degenerative lung diseases.

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Study shows potential of stem cell therapy to repair lung damage - Hindustan Times

The Cell Therapy Manufacturing Market, 2017-2027 report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options.

The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand.

Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.

The near-term demand for manufacturing of cell-based therapies will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage therapies (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for cell therapy manufacturing to grow at an annualized growth rate of -42% over the course of next ten years and be worth over USD 4 billion in 2027.

Companies Mentioned

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. CELL THERAPY MANUFACTURING: INTRODUCTION

4. MARKET OVERVIEW

5. ROADMAPS: POTENTIAL STRATEGIES TO OVERCOME EXISTING CHALLENGES

6. CELL THERAPY MANUFACTURING: IN-HOUSE MANUFACTURERS

7. CELL THERAPY MANUFACTURING: INDUSTRY PLAYERS

8. CELL THERAPY MANUFACTURING: NON-INDUSTRY PLAYERS

9. ROLE OF NON-PROFIT ORGANIZATIONS

10. RECENT DEVELOPMENTS

11. MARKET SIZING AND FORECAST

12. SWOT ANALYSIS

13. CONCLUSION

14. SURVEY ANALYSIS

15. INTERVIEW TRANSCRIPT

For more information about this report visit http://www.researchandmarkets.com/research/z9w7mt/cell_therapy

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Cell Therapy Manufacturing Market (2017-2027): Near-Term Demand Driven by Clincial Candidates - Research and ... - PR Newswire (press release)

Patients with a history of frequent anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of age-related macular degeneration (AMD) may not be the best potential candidates for encapsulated cell technology (ECT).

ECT contains human cell lines that are capable of producing a variety of proteins. After a single surgical implantation, they can produce proteins for up to two years or more, according to Szilard Kiss, MD, assistant professor of ophthalmology; director of clinical research at Weill Cornell Medical College, New York.

These cell lines survive even after being inside the human eye for six months, Dr. Kiss said.

A phase II study was initiated to compare the third generation of ECT (Neurotech, Cumberland, RI) to aflibercept (Eylea, Regeneron Pharmaceuticals). The study planned to enroll 90 subjects, with a primary outcome of non-inferiority to aflibercept alone after 108 weeks. Among the patient entry criteria, all patients had to have shown a response to aflibercept before randomization.

The patient profile was similar to other anti-VEGF treatment studies, with a best corrected visual acuity (BCVA) between 80 letters (20/25) and 35 letters (20/200) at baseline; limited pathology (such as fibrosis, scarring, or atrophy); good optical coherence tomography (OCT) response to injections; and having gone through at least three previous injections, with the last injection no more than four months before study enrollment.

The goal was to have fewer than 20% of patients needing a rescue injection during the follow-up period, Dr. Kiss said.

Study particulars

Unfortunately, there was not a significant difference between the implanted patients and those that received aflibercept. Those subjects that went on to 24 weeks may appear to have gained a little bit of vision, and one subject seemed to benefit, Dr. Kiss said. The OCT results show a saw-toothed pattern that we can see in patients who are treated with aflibercept every 8 weeks.

Although the responses look impressive, most subjects underwent rescue injections of aflibercept, Dr. Kiss said.

The time to rescue injections actually occurred as soon as 4 weeks after the implantation. And as such, there was early termination of the study, because it was not going to meet the primary endpoint of fewer than 20% needing injections, Dr. Kiss said.

However, the implantation itself was deemed successful, as the cells survived and produced the anti-VEGF molecule, but the amount that was produced was significantly below the 12 g/mL necessary.

There were two outlier subjects who had received an aflibercept injection alone about 10 days before the explant, and before measuring anti-VEGF activity. Dr. Kiss believes that to be the cause of the higher numbers compared to other subjects in the study.

None of the explants who did not receive aflibercept right before the explant produced enough anti-VEGF activity, he said.

Positive take-home

However, there had been indications the technology would be successful for this indicationa patient who had undergone six aflibercept injections during the previous year before enrollment did not need any injections (rescue therapy) during the 28 weeks before the AMD study terminated.

On the positive side, Dr. Kiss said the study results created new questions for the technologyincluding whether the approach could achieve better outcomes compared to real-world experience with other patient populations since the cell viability and stability was good.

The third generation ECT (NCT-503-3) did achieve the goal of improved VEGF-receptor production by at least 2-fold compared to double ECT (NT-503-2) implants. Further, while VEGF levels were not detectable, a complex formation was observed in the preliminary native gel.

While the AMD study has been halted, the company is investigating the technology in an ongoing phase II study in conjunction with the MacTel Project to investigate the long-term delivery of ciliary neurotrophic factor (CNTF) in people with macular telangiectasia (MacTel). A pilot study of neuro-enhancement in subjects with early visual impairment in collaboration with clinicians at Stanford University is also under way.

Most promising is that ECT is a unique and versatile drug delivery platform, with more than 1,000 patient years of safety data, Dr. Kiss added. The long-term continuous release of therapeutic proteins via ECT remains a viable and effective way to treat chronic ocular conditions.

Szilard Kiss, MD

E:[emailprotected]

This article is adapted from a presentation that Dr. Kiss presented at the Retina Subspecialty Day, prior to the 2016 American Academy of Ophthalmology meeting.

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Failed cell therapy study offers positives, raises new questions - ModernMedicine