137Regen. Med. (2014) 9(2), 137–143 ISSN 1746-0751

Business Development

Dusko Ilic, MD, PhDHuman Embryonic Stem Cell

Laboratories, Guys Assisted Conception

Unit, Division of Women’s Health, King’s

College London School of Medicine,

London, UK

dusko.ilic@kcl.ac.uk

Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from nonacademic institutions from 1 November 2013 until 31 December 2013

Collaborations, partnerships & alliancesCollaboration agreement: American CryoStem & Protein GenomicsAs part of its collaborative agreement to develop wound healing products and other cellular therapies, American CryoStem (NJ, USA; www.americancryostem.com) and Pro-tein Genomics (AZ, USA; www.proteinge-nomics.com) formed Autogenesis Corpora-tion. Owned 50/50 by the two companies, Autogenesis will serve as a dedicated business unit focused on continuing and accelerating the research and development of innovative new products and biotechnologies that com-bine American CryoStem’s adipose-derived ATcells™ and ACSelerate™ cell media culture products with Protein Genomics’ Elastatropin® human-based protein materials.

Collaboration agreement: Cellular Dynamics & Hamner InstituteThe Hamner Institutes for Health Sciences (NC, USA; www.thehamner.org) made a col-laborative agreement with Cellular Dynam-ics International (WI, USA; www.cellu-lardynamics.com) to develop predictive in vitro screening assays for chemical, environ-mental and pharmaceutical toxicology assessments that utilize company’s human induced pluripotent stem cell (iPSC)-derived hepatocytes.

Collaboration agreement: Kadimastem & Merck SeronoMerck Serono (Germany; www.merck-serono.com) and Kadimastem (Israel; www.kadimastem.com) signed a memorandum of understanding aimed at advancing their stem cell-based drug screening collaboration ini-tiated in 2012. Kadimastem has developed

technologies to differentiate stem cells into oligodendrocytes, which are brain cells that produce myelin, the insulation for the neural wiring. In multiple sclerosis, oligodendro-cytes are destroyed by the immune system. Kadimastem and Merck Serono have been leveraging cell-based drug screening technol-ogy to discover compounds that stimulate differentiation and myelination.

Manufacturing agreement: PharmaCell & DendreonPharmaCell (The Netherlands; www.phar-macell.nl) has entered into an agreement with Dendreon (WA, USA; www.dendreon.com) to be the Contract Manufacturing Organization for the European commercial production of its recently approved cellular immuno therapy product Provenge®, autolo-gous peripheral blood mononuclear cells acti-vated with prostate acid phosphatase–granu-locyte-macrophage colony-stimulating factor or sipuleucel-T dispersion for infusion.

Partnership agreement: Cytori & Lorem VascularCytori Therapeutics (CA, USA; www.cytori.com) and Lorem Vascular (China; www.loremvascular.com) announced a partnership to commercialize Cytori Cell Therapy for the cardiovascular, renal and diabetes markets in China, Hong Kong, Malaysia, Singapore and Australia. Under the agreement, Lorem Vas-cular committed to pay up to US$531 mil-lion in license fees, opening product purchase commitments and Cytori equity purchases. Cytori Cell Therapy is derived from the com-pany’s Celution® System, which enables access to patients own adipose-derived regenerative cells at the point of care. part of

Industry Update

10.2217/RME.14.2 © 2014 Future Medicine Ltd

Regen. Med.

Industry Update9

2

2014

For reprint orders, please contact: reprints@futuremedicine.com

138 Regen. Med. (2014) 9(2)

Partnership agreement: Mesoblast, Intrexon & ZiopharmMesoblast (Australia; www.mesoblast.com), Intrexon Corporation (VA, USA; www.dna.com) and Ziopharm Oncology (MA, USA; www.ziopharm.com) partnered to develop a new class of cancer therapeutics. The part-nership is a 50/50 collaboration between Mesoblast and Ziopharm, with Intrexon participating through its Exclusive Channel Collaboration with Ziopharm. Under the terms of the agreement the companies will combine Mesoblast’s proprietary Mesenchymal Lin-eage Cells with Intrexon’s RheoSwitch Therapeutic System® platform to codevelop complex transgene enabled cell-based treatments for oncology applica-tions. The goal of combining these technologies is to enable development of therapeutic candidates in the treatment of cancer, which exhibit both specific tumor-targeting characteristics and controlled gene expres-sion. If successful in feasibility studies targeting lung cancer, the companies expect to form a joint venture to advance development of therapeutic candidates.

Launching new projects, products & servicesGE Healthcare Life SciencesGE Healthcare Life Sciences, headquartered in Swe-den (www.gelifesciences.com) launched Xuri™, a new technology family designed specifically to support and advance the field of cell therapy. GE Healthcare’s new Xuri Cell Expansion System W25 is a function-ally closed, automated system, specifically designed to be suitable for the requirements of scaling-out cell therapies in a clinical setting. The system is equipped with dedicated software applications to make it suit-able for a regulated manufacturing environment and has been validated for T-cell growth. The Xuri W25 builds on the GE Healthcare’s WAVE Bioreactor™ technology, which is widely used in the development and manufacture of biopharmaceuticals globally.

Irvine ScientificIrvine Scientific (CA, USA; www.irvinesci.com) expanded cell therapy product portfolio with the launch of new media and recombinant growth factors. The product line is designed to provide an integrated workflow solution for the culture of human stem cells and primary cells. In addition to the existing PRIME-XV mesenchymal stem cell expansion serum-free medium, Irvine Scientific is introducing three new media. These new serum-free formulations are used for neural progenitor cell expansion, amniotic fluid stem cell expansion and tumor-sphere formation. To facilitate clinical applications, these media are manu-factured in an ISO13485 certified facility and have pending Drug Master Files. Additionally, Irvine Sci-

entific offers animal component-free, recombinant human growth factors such as Activin A, basic FGF 154 and granulocyte-macrophage colony-stimulating factor.

RegeneusWith the establishment of a new cell-processing laboratory, Australian regenerative medicine com-pany Regeneus (http://regeneus.com.au) has started offering its HiQCell® stem cell knee osteoarthritis therapy in Melbourne. HiQCell® uses a patient’s own stem cells from fat tissue to create the treatment and is considered a surgical procedure, resulting in lower regulatory requirements.

AchievementsBioTimeBioTime (CA, USA; www.biotimeinc.com) has pub-lished a peer-reviewed scientific paper on the successful generation of human cells with markers of particular cell types in the human brain [1]. The paper character-izes the cells generated from human embryonic stem cells using BioTime’s proprietary PureStem™ tech-nology. The study reports that the new cell lines show the potential to become cartilage and bone as well as brain-associated cells such as meninges and choroid plexus. These novel expandable and highly purified progenitors have properties that may have a wide array of future applications in the practice of orthopedics and neurology.

Cardio3 BioSciencesCardio3 BioSciences (Belgium; www.c3bs.com) announced publication of C-Cath® study results [2]. C-Cath is a nitinol curved needle catheter developed by Cardio3 BioSciences. Percutaneous catheter-based methods are an established route for delivery of regen-erative biologics to the heart. However, the current devices and methodologies are associated with a sig-nificant loss of the delivered stem cell dose in the gen-eral circulation, creating a barrier to the efficiency of local delivery of therapeutic agents. The study demon-strated that a curved needle design featuring small-to-large graded side holes resulted in a significant increase in cell retention in both healthy and infarcted hearts. More precisely, a curved needle design eliminated backflow of injectate and limited loss in the general circulation, and the use of a small-to-large graded side-hole design diminished interstitial pressure during delivery to improve diffusion and cell viability.

MiMedxMedicare contractor, CGS (TN, USA; www.cgs-medicare.com) has confirmed that the wound care

future science group

News & Views Industry Update

www.futuremedicine.com 139

allograft, EpiFix®, manufactured by MiMedx Group (GA, USA; www.mimedx.com), has received reim-bursement coverage from CGS. The coverage by CGS now brings the total Medicare Administrative Con-tractors covering EpiFix to six of the eight and 86% of Medicare beneficiaries will now be eligible for cov-

erage for EpiFix products. CGS approved EpiFix for both diabetic foot ulcers and venous leg ulcers that fail to respond to standard of care treatments. The approval was retroactively effective to 1 November 2013. Of the six Medicare Administrative Contractors that cover EpiFix, five cover both types of ulcers.

Clinical Trials

BioheartBioheart (FL, USA; www.bioheartinc.com) will enroll up to 100 patients in a study for dry macular degenera-tion to determine the safety and efficacy of their adi-pose-derived stem cells or AdipoCell™ in patients with dry macular degeneration. Further information about the clinical trial is available at http://clinicaltrials.gov (NCT02024269).

ImmunoCellular TherapeuticsImmunoCellular Therapeutics (CA, USA; www.imuc.com) announced that the first patient in the Phase I clinical trial of ICT-121, a cancer vaccine targeting recurrent glioblastoma multiforme, has received the vaccine. ICT-121 is a dendritic cell vaccine targeting CD-133, an important cancer stem cell marker that is commonly expressed on a broad range of solid tumors. The investigator-sponsored Phase I trial is being con-ducted at Cedars-Sinai Medical Center in Los Angeles (CA, USA; http://cedars-sinai.edu). ImmunoCellu-lar is supporting the trial by providing the ICT-121 vaccine.

Cedars-Sinai presented at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology findings from similar clinical study in which 16 glio-blastoma patients were treated with ImmunoCellular’s ICT-107 vaccine. Seven of the 16 participants still are living, with length of survival ranging from 60.7 to 82.7 months after diagnosis. Six of the patients also were ‘progression free’ for more than 5 years, meaning the tumors did not return or require more treatment during that time. Four participants still remain free of disease with good quality of life at lengths ranging from 65.1 to 82.7 months following diagnosis. One patient who remained free of brain cancer for 5 years died of leukemia. All eight long-term survivors had tumors with at least five antigens, 75% had tumors with all six, and 100% had tumors with at least four antigens associated with cancer stem cells – cancer-originating cells that appear to enable tumors to resist radiation and chemotherapy and even regener-ate after treatment. Further information about the clinical trial is available at http://clinicaltrials.gov (NCT01280552).

Living Cell TechnologiesLiving Cell Technologies (New Zealand; www.lct-global.com) announced the findings of DIA-09 – a Phase I/IIa clinical trial of DIABECELL® in patients with Type 1 diabetes. The nonrandomized, open-label study was conducted at the Hospital Eva Perón (Bue-nos Aires, Argentina). The trial involved eight patients split into two groups of four. Group one received two 5000 islet equivalents per kg of bodyweight (IEQ/kg) doses of DIABECELL. Group two received two 10,000 IEQ/kg doses of DIABECELL. In both groups, the second dose was implanted 12 weeks after the first. End points were assessed 52 weeks after the second implant. The average daily insulin dose was reduced in seven of eight patients. Treatment with DIABECELL involves transplanting pig pancreatic islet cells into a patient’s abdomen to boost insulin production and help regulate blood glucose levels. The cells are encap-sulated with IMMUPEL™ to prevent the immune system rejecting them as foreign. This proprietary technology ensures the cells can deliver their benefi-cial effects without the patient requiring immunosup-pressant drugs. DIABECELL is owned by the joint venture company Diatranz Otsuka Limited, in which Living Cell Technologies and Otsuka Pharmaceuti-cal Factory both have a 50% interest. Further infor-mation about the clinical trials is available at http://clinicaltrials.gov (NCT00940173, NCT01736228, NCT01739829).

Living Cell Technologies also announced that the independent data safety monitoring board has reviewed the safety data from the initial patient in the Phase I/IIa clinical trial of NTCELL® and advised that implants for the additional three patients in the trial can proceed. The Phase I/IIa clinical trial is an open-label investigation of the safety and clinical effects of NTCELL in four patients who have been diagnosed with Parkinson’s disease for at least 5 years. NTCELL is a choroid plexus cell product with the potential to treat Parkinson’s disease and other disorders, such as stroke, Huntington’s disease and hearing loss, as well as wound healing. These cells help produce cerebrospi-nal fluid, as well as a range of neurotrophins that have been shown to protect against neuron cell death in

future science group

Industry Update News & Views

140 Regen. Med. (2014) 9(2)

animal models of disease. Further information about the clinical trial is available at http://clinicaltrials.gov (NCT01734733).

MesoblastMesoblast (Australia; www.mesoblast.com) announced that the US FDA has cleared the Investigational New Drug (IND) filing made by Mesoblast’s development and commercial partner Teva Pharmaceutical Indus-tries (Israel; www.tevapharm.com) to commence a Phase III trial in patients with chronic congestive heart failure using Mesoblast’s proprietary mesenchymal precursor cells (MPCs). The FDA cleared the IND within the minimum 30-day period following submis-sion. The multicenter trial, which will be conducted by Teva, is planned to enroll approximately 1700 patients and includes two interim analyses of efficacy and/or safety. The clinical protocol was designed after initial consultation with both the FDA and the EMA. The Phase III trial design is a double-blinded, 1:1 random-ized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of heart failure patients with New York Heart Association class II or III disease and an ejection fraction ≤40%. The primary efficacy end point of the trial is a time-to-first event analysis of heart failure-related major adverse cardiac events, defined as a composite of cardiac related death or resuscitated cardiac death, or nonfatal decompensated heart failure events. These nonfatal decompensated heart failure events require use of intravenous diuret-ics or aquapheresis during an in-hospital stay or during an outpatient visit. Adjudication of heart failure-related major adverse cardiac events will be performed by an independent, blinded clinical end point committee.

Mesoblast also announced top-line results from the Phase II trial of its proprietary MPCs in subjects with

Type 2 diabetes. The results of the trial support the safety and tolerability of a single intravenous infusion of MPCs in Type 2 diabetes. Additionally, there was an improvement in glycemic control as evidenced by reduc-tion in HbA1c. The Phase II randomized, single-blind, placebo-controlled, dose-escalation trial was conducted across 18 sites in the USA. The trial evaluated the effects of a single intravenous infusion of 0.3, 1.0 or 2.0 mil-lion MPCs/kg or placebo over 12 weeks in 61 patients with a mean diabetes duration of 10 years. The highest dose showed the greatest overall reduction in HbA1c, with a peak decrease of 0.4% at 8 weeks compared with placebo (p < 0.05), and a decrease of 0.3% at 12 weeks. Further information about the clinical trial is available at http://clinicaltrials.gov (NCT01576328).

Vomaris Wound CareVomaris Wound Care (AZ, USA; http://procellera.com) has launched a clinical study to investigate Pro-cellera® wound dressing on acute wound healing in the US Army 4th Ranger Training Brigade in Geor-gia (USA). Procellera is a unique wound dressing with wireless microcurrent technology that provides an advanced wound healing solution for the manage-ment of wounds. Silver and zinc are applied on the device surface in a dot matrix pattern, creating mul-tiple microbatteries. In the presence of moisture, low-level microcurrents are generated at the device sur-face. These reactions occur without an external power source or accessories. The US$1 million research ini-tiative is funded by a grant from the US Army Medi-cal Materiel Command (http://mrmc.amedd.army.mil). The randomized two-arm study will involve up to 80 rangers. The study is designed to evaluate the efficacy of Procellera versus the current Army meth-ods. Procellera is already available to the public and is used in hospitals, as well as available over the counter.

Regulations, Approvals & Acquisitions

RegulationsIndiaIn October 2013, the Indian Supreme Court ordered the central government to issue regulations mandating videotaped informed consent of all participants in any clinical trial conducted on Indian soil, as well as addi-tional cost–benefit analyses of potential drugs before trials can proceed. The precedent-setting directive comes as the two-judge panel continues to hear argu-ments on a petition filed in January 2012 alleging that multinational drug companies and Indian collabora-tors are using underprivileged Indians as guinea pigs in clinical trials. In July, the court ordered a temporary

halt to 162 clinical trials then under way in India. In October permitted five trials to resume and referred the other 157 to a new government advisory committee for more detailed scrutiny.

JapanThe Japanese Society for Regenerative Medicine (www.asas.or.jp/jsrm/english/index.html) will establish a certification system for physicians with expertise and skills in regenerative medicine and for medical techni-cians adept at cell culturing techniques as early as fall 2014. The system is designed to qualify such doctors as experts in regenerative medical treatment and techni-

future science group

News & Views Industry Update

www.futuremedicine.com 141

cians as specialists in clinical cell culture. The society hopes to combine the scheme with a planned govern-ment administered system requiring medical institu-tions to report their regenerative medical services to the authorities.

Green lightAthersysThe Committee for Orphan Medicinal Products of the EMA has issued a positive opinion (EMA/OD/146/13) for allogeneic, multipotent adult progenitor cell Multi-Stem® therapy for the prevention of graft-versus-host disease (GvHD) manufactured by Athersys (OH, USA; www.athersys.com). The company is developing its MultiStem cell therapy as a GvHD prophylaxis in patients undergoing allogeneic hematopoietic stem cell transplant and is currently preparing for a Phase II/III clinical study in the area. The MultiStem therapy for the prevention of GvHD has also previously been granted orphan drug designation by the FDA.

CapricorCapricor Therapeutics (CA, USA; www.capricor.com) has received notification from the National Heart Lung and Blood Institute Gene and Cell Therapy Data Safety Monitoring Board that the 14-patient Phase I portion of the Company’s ALLSTAR Phase I/II clini-cal trial has met its safety end points and that the Company is now cleared to begin the Phase II portion of the ALLSTAR clinical trial. Capricor’s ALLSTAR Phase I/II clinical trial is evaluating its CAP-1002 allogeneic cardiac-derived cell product candidate in reducing infarct scar size in patients who have suf-fered a heart attack. The estimated 300-patient, dou-ble-blind, randomized, placebo-controlled Phase II portion of the ALLSTAR clinical trial is powered to detect a reduction in infarct size as measured by MRI in patients following a large myocardial infarction more than 30 days and less than 12 months prior to treatment with CAP-1002. The trial is subrandomized into an ‘early’ group (30–90 days post heart attack) and a ‘late’ group (91–365 days post heart attack). Each group is powered sufficiently to provide both a safety and efficacy readout. Phase I of the ALLSTAR trial was funded in part by a grant received from the NIH. Phase II is being funded with the support of the California Institute for Regenerative Medicine. Fur-ther information about the clinical trial is available at http://clinicaltrials.gov (NCT01458405).

Cellular Biomedicine GroupCellular Biomedicine Group (CA, USA; http://cellbiomedgroup.com) has received approval to con-duct a Phase IIb clinical trial for ReJoin™, a human

adipose-derived MPC therapy bioengineered for Knee Osteoarthritis. The trial tests the safety and efficacy of intra-articular injections of autologous ReJoin formula in order to reduce inflammation and repair damaged joint cartilage.

PharmalinkPharmalink (Sweden; www.pharmalink.se) has received orphan drug designation from the FDA for its product Busulipo®. Bulispo has been developed as a liposome/lipid complex formulation that improves the safety and stability of the chemotherapy agent busul-fan. An early Busulipo formulation has successfully undergone clinical trials with more than 90 patients treated. The company is currently preparing for regis-tration trials with an optimized formulation of Busu-lipo as part of its plans to advance the product towards the market.

PluristemPluristem (Israel; www.pluristem.com) announced that the South Korean Ministry of Food and Drug Safety, formerly the Korea FDA, has approved Plu-ristem’s IND application to conduct a Phase II study using PLX-PAD cells for the treatment of intermit-tent claudication, a subset of peripheral artery disease. The IND approved by the Ministry of Food and Drug Safety mirrors INDs already approved by regulators in the USA, Germany and Israel. South Korea will be the fourth country participating in this multinational trial involving the use of PLX-PAD in intermittent claudi-cation. CHA Bio&Diostech (http://en.chabio.com), Pluristem’s South Korean partner, will fund the trial and conduct it in its healthcare facilities.

TxCellTxCell (France; www.txcell.com), a biotechnology company developing personalized cell-based immuno-therapies using antigen-specific Tregs for chronic inflammatory and autoimmune diseases, has received a manufacturing accreditation delivered by the French National Agency for Drug Safety. The status has been received for its cell therapy production site in Besan-çon (France). The TxCell manufacturing facility, located at the French National Blood Center of Bour-gogne Franche-Comté region, is now authorized to produce biological investigational medicinal products in accordance with the European Union Directives 2001/83/EC and 2001/20/EC, as required for the manufacturing of Advance Therapy Medicinal Prod-uct. TxCell’s lead autologous antigen-specific Treg-based immunotherapy, Ovasave®, is currently in Phase II development for the treatment of Crohn’s disease in patients who are refractory to current treatments. Ova-

future science group

Industry Update News & Views

142 Regen. Med. (2014) 9(2)

save has been classified as Advance Therapy Medicinal Product since 2009 by the EMA. The newly accredited TxCell manufacturing facility will enable production of pharmaceutical grade batches of Ovasave for the next Phase IIb study, planned to start mid 2014.

PendingBioheartBioheart (FL, USA; www.bioheartinc.com) asked the FDA to approve ‘compassionate use’ access for its MyoCell™ and LipiCell™ cell therapy products in at-risk heart failure patients with no alternatives.

AcquisitionsNuvilex & SG AustriaNuvilex (MD, USA; www.nuvilex.com) has acquired the exclusive worldwide rights to use the

cellulose-based live-cell encapsulation technology for the development of treatments for diabetes from SG Austria, which is operating as Austrianova, Singapore (http://austrianova.com). Nuvilex has secured US$1.5 million in funding through the sale of restricted stock to accredited investors at a fixed price of US$0.15 per share, a premium to the current market price per share, to complete this acquisition.

Name changeAmerica Stem Cell (TX, USA; www.americas-temcell.com) has changed its name to Targazyme (http://targazyme.com). The new name was selected to ref lect the company’s family of enzyme prod-ucts aimed at improving cell targeting for better outcomes in stem cell and regenerative medicine.

Capital Market & Finances

BioTimeBioTime (CA, USA; www.biotimeinc.com) and its subsidiary Cell Cure Neurosciences (www.cellcure-neurosciences.com) have been awarded a grant for 2014 of US$1.74 million (6.1 million Shekels) from Israel’s Office of the Chief Scientist (OCS; www.matimop.org.il/ocs.html) to help finance the development of OpRegen®, a cell-based therapeutic product in devel-opment by Cell Cure for the treatment of age-related macular degeneration. Cell Cure’s plans for the devel-opment of OpRegen include completion of preclinical testing and filing an IND application to commence human clinical trials in 2014.

BrainStormBrainStorm Cell Therapeutics (Israel; www.brain-storm-cell.com) was awarded a US$800,000 non-dilutive grant from Israel’s OCS for the year 2014. The grant is intended to support BrainStorm’s clinical and product development for its innovative stem cell ther-apy candidate NurOwn™. The OCS has supported BrainStorm Cell Therapeutics Ltd since 2007, provid-ing grants of a total of approximately US$3 million until today. The company is required to pay royalties to the OCS, amounting to 3–3.5% of revenues derived from sales of the products funded with these grants, but only up to the amount equal to 100% of the grants received plus LIBOR interest.

Cellular Dynamics InternationalCellular Dynamics International (WI, USA; www.cel-lulardynamics.com) has received the Notice of Grant Award from the California Institute of Regenerative

Medicine (CIRM; www.cirm.ca.gov) to create a human iPSC biobank from 3000 individuals. Receipt of the Notice of Grant Award signifies the entry into a definitive agreement with CIRM and the initiation of funding for the US$16 million project. Since CIRM announced the US$16 million grant award, the com-pany has been constructing their laboratory and iPSC manufacturing facilities in leased space at the Buck Institute for Research on Aging (CA, USA; www.buckinstitute.org), as well as staffing this facility.

DefinigenDefinigen, UK (www.definigen.com) has raised new funding of US$2.15 (GBP£1.3 million) to advance its stem cell technology business from a UK platform. The cash will be used to launch new stem cell products for disease modeling and drug discovery. The com-pany supplies hepatocytes for preclinical drug devel-opment and disease modeling applications using iPSC technology.

International Stem Cell CorporationInternational Stem Cell Corporation (CA, USA; www.internationalstemcell.com) has entered into a pur-chase agreement with Lincoln Park Capital Fund (IL, USA; www.lpcfunds.com). The fund has committed to invest up to US$10.25 million of the company’s common stock over a 36-month term.

OrganogenesisOne of the most successful regenerative medicine com-panies, Organogenesis (CA, USA; www.organogesesis.com) had to slash up to 200 jobs as part of its company-

future science group

News & Views Industry Update

www.futuremedicine.com 143

wide reorganization in the face of Medicare’s decision to cut what it is paying for its wound-healing medicine Apligraf. The axe fell primarily on staffers working on ‘innovation and new products’ and the company started handing out 60-day severance pay to everyone but the director and two managers in Research and Development, and all but four positions in medical and clinical. The cutbacks were forced by Medicare’s decision to issue final rules that will ‘bundle’ the com-pany’s wound-healing regenerative medicine Apligraf at a reduced price of US$1371. Bundling is a process in which Medicare comes up with a price for a single episode of care, capping its exposure.

StemCell TechnologiesStemCell Technologies (BC, Canada; www.stem-cell.com), have received from the National Research Council of Canada Industrial Research Assistance Program up to US$1.5 million in financial support for the development of cell isolation technology that will further basic and translational HIV research, as well as broader research in infectious disease. This new cell isolation technology will give researchers easy access to specific, rare populations of immune

cells from HIV-infected patient samples, enabling the study of immune responses to HIV, the development of models and assays to study HIV infection and ulti-mately the rational design of new vaccines that will save lives.

Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement

with any organization or entity with a financial interest in or fi-

nancial conflict with the subject matter or materials discussed

in the manuscript. This includes employment, consultancies,

honoraria, stock ownership or options, expert testimony,

grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this

manuscript.

References1 Sternberg H, Jiang J, Sim P et al. Human embryonic stem

cell-derived neural crest cells capable of expressing markers of osteochondral or meningeal-choroid plexus differentiation. Regen. Med. 9, 53–66 (2014).

2 Behfar A, Latere JP, Bartunek J et al. Optimized delivery system achieves enhanced endomyocardial stem cell retention. Circ. Cardiovasc. Interv. 6(6), 710–718 (2013).

future science group

Industry Update News & Views