Industry update: Latest developments in stem cell research and regenerative medicine

Abstract

Regenerative MedicineVol. 8, No. 4 News & ViewsFree AccessIndustry update: Latest developments in stem cell research and regenerative medicineDusko IlicDusko IlicHuman Embryonic Stem Cell Laboratories,Guy ’s Assisted Conception Unit, Division of Women’s Health, King’s College London School of Medicine, London, UK. Search for more papers by this authorEmail the corresponding author at dusko.ilic@kcl.ac.ukPublished Online:4 Jul 2013https://doi.org/10.2217/rme.13.45AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Business Development▪ Collaborations, partnerships & alliancesCodevelopment agreement: BioLamina & RocheBioLamina, Sweden (www.biolamina.com), and Roche, Switzerland (www.roche.com), signed a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will focus on assessing laminin-based in vitro cell culture matrices offering highly physiological microenvironments for living cells. Under the terms of the agreement Roche will provide R&D funding and scientific expertise to BioLamina. Financial details were not disclosed.Collaboration agreement: Cellectis Bioresearch & StemgentCellectis Bioresearch, France (www.biolamina.com), signed a collaboration agreement with Stemgent, MA, USA (www.stemgent.com), to provide research services that combine mRNA reprogramming technology and genome engineering. Stemgent’s proprietary mRNA reprogramming technology addresses the challenges around deriving nonviral, nonintegrating, clinically relevant induced pluripotent stem (iPS) cells for use in regenerative medicine, drug discovery and basic research. Cellectis Bioresearch’s TALEN™-based genome engineering technology enables the directed introduction of disease-specific genetic mutations to mimic disease and of reporter genes with fluorescent/luminescent tags to evaluate drug candidate efficacy, specificity and toxicity. The companies hope that these two powerful technologies will pave the way for clinically relevant applications in regenerative medicine.Collaboration agreement: VistaGen Therapeutics & Celsis In Vitro TechnologiesVistaGen Therapeutics, CA, USA (www.vistagen.com), and Celsis In Vitro Technologies, MD, USA (www.celsisivt.com), have agreed to collaborate on characterizing and functionally benchmarking VistaGen’s human liver cell platform, LiverSafe 3D™, with Celsis products for studying and predicting human liver drug metabolism.License agreement: Bellvitge Biomedical Research Institute & HistocellThe Bellvitge Biomedical Research Institute (IDIBELL), Spain (www.idibell.cat), has signed a licensing agreement with the Spanish biotech company Histocell (www.histocell.com/en), to make use of a patent for the treatment of acute pulmonary diseases with mesenchymal stem cells. These cells, administered intravenously, have the ability to go directly to the damaged lungs, acting as a ’smart drug’. To enhance the effect, researchers have modified these cells by genetic engineering to secrete IL-33.License agreement: Life Technologies & Harvard UniversityLife Technologies, CA, USA (www.lifetechnologies.com), signed a research and license agreement with Harvard University, MA, USA (www.harvard.edu), under which the firm has acquired exclusive rights to develop a panel of characterization assays designed to rapidly evaluate human pluripotent stem cells for their utility in a variety of discovery and translational research applications. The panel will be offered on the company’s semiconductor sequencing and PCR-based genetic analysis platforms.Licensing agreement: Stemedica Cell Technologies & PT Kalbe Farma TbkStemedica Asia, a wholly-owned subsidiary of Stemedica Cell Technologies, CA, USA (www.stemedica.com), has entered into a definitive licensing agreement with the Stem Cell and Cancer Institute, a division of PT Kalbe Farma Tbk, Indonesia (www.kalbe.co.id). Under the terms of the agreement Kalbe shall be the exclusive licensor of Stemedica’s ischemia-tolerant adult allogeneic mesenchymal and neural stem cells for use in clinical trials in Indonesia, Philippines and Thailand. The agreement also provides Kalbe with first rights of refusal for additional countries including Singapore, Malaysia, Vietnam, Brunei, Cambodia, Laos and Myanmar. Kalbe’s Stem Cell and Cancer Institute shall be responsible for organizing and funding clinical trials in southeast Asia. Kalbe is the largest publicly listed pharmaceutical company in southeast Asia with close to US$6 billion in market capitalization as of the first quarter of 2013.Memorandum of understanding: BrainStorm Cell Therapeutics & Mayo ClinicBrainStorm Cell Therapeutics, Israel (www.brainstorm-cell.com), and the Mayo Clinic, MN, USA (www.mayoclinic.org/rochester), has entered into a memorandum of understanding with the intent to conduct a Phase II clinical trial of NurOwn™ in amyotrophic lateral sclerosis, more commonly known as Lou Gehrig’s disease. Mayo Clinic is the third US clinical site to sign a memorandum of understanding with the company, following the University of Massachusetts (MA, USA) and Massachusetts General Hospital (MA, USA).▪ Launching new projects, products & servicesamsbioamsbio, UK (http://amsbio.com), launched a new, highly purified Chondroitinase ABC. This new enzyme is supplied protease-free, carrier-free and with low endotoxin levels for use in neuroscience and regenerative medicine research.Fujifilm Diosynth BiotechnologiesFujifilm Diosynth Biotechnologies, UK (www.fujifilmdiosynth.com), commissioned a new mammalian current Good Manufacturing Practice cell banking facility (CBF) at its Billingham, UK site. Clients can contract with the new CBF either as part of a larger development and manufacturing program or as a standalone service. The CBF forms the second stage of a major expansion of the company’s mammalian cell culture capabilities at the site, following installation last year of new process development and scale-up capabilities.Imstem BiotechnologyA new stem cell company, Imstem Biotechnology, CT, USA (http://imstem.com), is the latest research venture to join the University of Connecticut (CT, USA) Technology Incubation Program (http://innovation.uconn.edu/Programs/Technology_Incubation_Program). Imstem currently operates with financial support of the angel investor and cofounder aiming to explore new approaches of utilizing human embryonic stem cell lines for future clinical applications.Osiris TherapeuticsOsiris Therapeutics, MD, USA (www.osiris.com), introduced a proprietary, direct sales force for Grafix®, a cellular repair matrix for serious wounds including diabetic foot ulcers. In 2012, Osiris had received transitional pass-through status from the Center for Medicare & Medicaid Services (MD, USA), with C-Codes being designated for Grafix. More recently, specific codes were added to the Healthcare Common Procedure Coding System for Grafix PRIME and Grafix CORE. The team of biologics sales professionals will initially be deployed in ten major metropolitan areas throughout the USA and is expected to double over the coming year. Osiris medical affairs staff and a team of stem cell scientists will be supporting field representatives.StemCell TechnologiesStemCell Technologies, BC, Canada (www.stemcell.com), launched distribution of Vitronectin XF™, a defined, xeno-free cell culture matrix that supports the growth and differentiation of human pluripotent stem cells. Vitronectin XF is developed and manufactured by Primorigen Biosciences, WI, USA (www.primorigen.com).▪ AchievementsBiosafeBiosafe, Switzerland (www.biosafe.ch), is celebrating a landmark, with the manufacture of the one millionth proprietary SEPAX separation chamber for cord blood processing kits.Cell Therapy CatapultCell Therapy Catapult (http://ct.catapult.org.uk/), which is focused on the development of the UK cell therapy industry, has published its database of ongoing clinical trials in this area in the UK.CerapedicsCerapedics, CO, USA (www.cerapedics.com), has announced that more than 10,000 patients have been treated with its product i-FACTOR™ worldwide since the product became available outside the USA in late 2008. i-FACTOR Peptide Enhanced Bone Graft incorporates Cerapedics’ proprietary anorganic bone mineral and synthetic small peptide (P-15™) technologies for use in wide variety of spine, trauma and orthopedic surgical procedures. i-FACTOR is not commercially available in the USA, where it is, as an investigational device, limited by federal law to investigational use only.Cord Blood RegistryCord Blood Registry, CA, USA (www.cordblood.com), released its 250th cord blood unit for medical use.Clinical TrialsInternational Stem Cell CorporationInternational Stem Cell Corporation, CA, USA (www.internationalstemcell.com), has developed a sophisticated and efficient manufacturing process for producing highly pure populations of Good Manufacturing Practice-grade neuronal cells suitable for preclinical studies and clinical trials [1]. The neuronal cells created using this approach are further characterized using a number of analytical methods and shown to function in a similar manner to adult cells. Moreover, neuronal cells produced using this new method express greater levels of dopamine, the neurotransmitter central to Parkinson’s disease, than previously reported approaches. Furthermore, these human parthenogenetic stem cell-derived neuronal cells are cryopreservable and can be stored frozen, and provide a practical route to creating neurons of sufficient quality to be used to treat Parkinson’s disease patients.Medinet & MaxCyteMedinet, Japan (www.medinet-inc.co.jp/english) and MaxCyte, MD, USA (www.maxcyte.com), published the results of their scientific collaboration demonstrating that the use of MaxCyte’s cell loading technology results in 5–20-fold enhancement in potency of dendritic cell vaccines [2].Minerva BiotechnologiesMinerva Biotechnologies, MA, USA (www.minervabio.com), reported for the first time that generically unmodified human stem cells were converted to, and maintained in, the ’naive’ state by culturing the cells in the dimeric form of a naturally occurring protein called NM23H1 [3,4]. The NM23H1-cultured stem cells had a much higher cloning efficiency than the same cells cultured in FGF-containing media. The Minerva system is free of feeder cells, conditioned media and exogenously added cytokines or growth factors, other than NM23H1. After initial acclimation to the new media, the stem cells remain essentially 100% pluripotent, requiring no manual dissection or other manipulations that would interfere with large-scale production and automated stem cell culture.Organovo HoldingsOrganovo Holdings, CA, USA (www.organovo.com), presented data on the company’s in vitro 3D liver at the 2013 Experimental Biology conference in Boston, MA, USA. For the first time, human liver tissues have been generated that are truly 3D, being up to 500 µm in thickness in the smallest dimension, and consisting of multiple cell types arranged in defined spatial patterns that reproduce key elements of native tissue architecture. The tissues, fabricated using Organovo’s proprietary NovoGen™ bioprinting platform, are highly reproducible and exhibit superior performance compared with standard 2D controls.ViaCordViaCord, MA, USA (www.viacord.com), released its 250th umbilical cord blood stem cell unit for use in medical treatments and clinical trials.▪ Advanced Cell TechnologyAdvanced Cell Technology, MA, USA (www.advancedcell.com), initiated treatment of patients in the third patient cohort in all three clinical trials for macular degeneration. The patients were injected with 150,000 human embryonic stem cell-derived retinal pigment epithelial cells, as compared with the 100,000-cell dose used in the previous three patients of the second cohort. Further information about the company’s clinical trials for macular dystrophy are available at www.clinicaltrials.gov (ID: NCT01469832, NCT01345006 and NCT01344993).▪ Cardio3 BioSciencesCardio3 BioSciences, Belgium (www.c3bs.com), announced publication of C-Cure (Phase II) trial results [5]. The C-Cure trial was a prospective, multicenter, randomized study to evaluate the feasibility, safety and efficacy of CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy. CQR-1 consists of the patient’s own stem cells harvested from the bone marrow and engineered to become progenitors of new functional cardiac cells. The publication concluded that therapy with CQR-1 (previously C-Cure) was feasible and safe with signals of benefit in chronic heart failure, meriting further definitive clinical evaluation. On the basis of these outcomes, Cardio3 BioSciences has initiated a Phase III trial for CQR-1, called CHART-1, for Congestive Heart failure Cardiopoietic Regenerative Therapy. This is the first Phase III trial using organ-specified cells for the treatment of ischemic heart failure and will recruit approximately 240 patients with chronic advanced symptomatic heart failure. Further information about these two clinical trials is available at www.clinicaltrials.gov (ID: NCT00810238 and NCT01768702).▪ Cellular Biomedicine GroupCellular Biomedicine Group, CA, USA (www.cellbiomedgroup.com), launched a clinical trial for human adipose-derived mesenchymal progenitor cell therapy for knee osteoarthritis. The trial is being conducted by Shanghai’s Renji Hospital, affiliated to Shanghai Jiao Tong University School of Medicine, China (http://english.shsmu.edu.cn/default.php?mod=article&do=detail&tid=329553). A small amount of adipose tissue obtained via liposuction from the patient is processed for immediate injection into the knee area, with the remaining tissue to be further processed to purify, expand and bank for additional injections 1 and 3 months later. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01809769).▪ CelsenseCelsense, PA, USA (www.celsense.com), announced that the first patient with transplanted cells imaged by MRI, using the company’s Cell Sense technology, has been treated at the University of Pittsburgh Cancer Institute (PA, USA). US FDA cleared the Phase I clinical trial for the purposes of developing information regarding cell migration following administration of live cells. Cell Sense is a patented fluorocarbon-based emulsion tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are transplanted into the patient, enabling researchers and clinicians to noninvasively track the administration and migration of therapeutic and/or diagnostic cells using 19F-MRI or nuclear magnetic resonance spectroscopy. Applications include tracking cells in immunotherapy or regenerative medicine as well as diagnosis of inflammatory sites by tracking selected populations of immune cells. Cell Sense is the subject of a drug master file at FDA and Health Canada, and is the only clinical grade MRI cell tracking reagent available in North America. Using software developed by Celsense, investigators can quantify the number of labeled cells in a user-specified region of interest.▪ Fibrocell ScienceFibrocell Science, PA, USA (www.fibrocellscience.com), published results of its Phase II study to evaluate the safety and efficacy of azficel-T (LAVIV®) for the treatment of patients with moderate-to-severe acne scars [6]. The findings demonstrated that azficel-T treatment was associated with clinically meaningful improvement in acne scar appearance and was judged safe and superior to control treatment. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT00642642).▪ PluristemFollowing favorable preclinical studies and approval by the Australian regulatory authorities, Pluristem, Israel (www.pluristem.com), is recruiting for a human Phase I clinical trial in Australia using PLacental eXpanded (PLX-PAD) cells in patients diagnosed with pulmonary arterial hypertension. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01795950).▪ SironRX TherapeuticsSironRX Therapeutics, OH, USA (www.sironrx.com), which is a privately held, clinical-stage biotechnology company developing novel regenerative therapies to prevent scarring and promote dermal wound repair, has completed enrollment of patients in cohort 1 of its placebo-controlled, randomized, dose escalation double-blind clinical study evaluating the safety and efficacy of JVS-100 (SRX-100) to reduce scar formation and improve wound healing in patients receiving surgical sternotomy incisions. Cohort 2 is actively being enrolled. SRX-100, the company’s lead product, exclusively licensed from Juventas Therapeutics, OH, USA (www.juventasinc.com), and Cleveland Clinic, OH, USA (http://my.clevelandclinic.org/default.aspx), encodes SDF-1, an important natural chemokine that repairs damaged tissue through recruitment of circulating stem cells to the site of injury, prevents ongoing cell death and restores localized blood flow.▪ StemCellsStemCells, CA, USA (www.stemcellsinc.com), adds Byers Eye Institute at Stanford, CA, USA (http://stanfordhospital.org), as the second site of its proprietary HuCNS-SC® product candidate (purified human neural stem cells) Phase I/II clinical trial in dry age-related macular degeneration. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01632527).Regulations, Approvals & Acquisitions▪ Green lightAthersysAthersys, OH, USA (www.athersys.com), announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved its application to expand its ongoing Phase II study evaluating the administration of MultiStem® therapy to patients who have suffered an ischemic stroke. Enrollment at UK sites is expected to commence following final ethics committee review and the completion of final preparations at participating clinical centers. The study is expected to enroll approximately 136 patients in total and is currently being conducted at multiple centers throughout the USA. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01436487).Bone TherapeuticsBone Therapeutics, Belgium (www.bonetherapeutics.com), has been awarded both ’Tissue Establishment’ and ’Good Manufacturing Practice’ accreditation for the manufacturing of its allogeneic bone cell therapy product ALLOB®, being initially developed for the treatment of impaired fractures.CytomedixThe Center for Medicare & Medicaid Services has granted formal approval of the clinical outcomes defined in four protocols developed and submitted by Cytomedix, MD, USA (www.cytomedix.com), in response to the National Coverage Determination memorandum for autologous blood-derived products for chronic wound. With these protocol approvals, clinicians can use AutoloGel™ to treat Medicare beneficiaries with chronic wounds and receive reimbursement for the product under the coverage with evidence development. Under the approved protocols, Cytomedix initially expects to treat more than 1200 patients with AutoloGel in outpatient wound care centers.Under the approved protocols, Cytomedix initially expects to treat more than 1200 patients with AutoloGel in outpatient wound care centers. The four approved protocols are: CM001, multicenter, randomized, controlled trial comparing the efficacy of AutoloGel therapy plus usual and customary care (UCC) to UCC alone in diabetic foot ulcers; CM002–4: three independent multicenter, cohort studies designed to compare AutoloGel plus UCC with UCC alone in diabetic foot ulcers, pressure ulcers and venous ulcers. These protocols will be rolled out initially at up to 30 USA Wound Registry Research Network centers, and up to ten non-network centers. The protocols will be registered at www.clinicaltrials.gov.Human Stem Cells InstituteThe Ministry of Healthcare of Ukraine issued marketing authorization to Human Stem Cells Institute, Russia (http://eng.hsci.ru/home), for Neovasculgen®. The drug contains the VEGF gene embedded in a plasmid vector (carrier). Neovasculgen stimulates the growth of collateral blood vessels and, as a result, promotes a long-term therapeutic effect.In addition, an agreement has been signed to supply the Russian pharmaceutical company Sotex PharmFirm with Neovasculgen. During the first year of the 3-year agreement, sales will total US$6.85 (RUB211.75) million.HumancyteHumancyte, NC, USA (www.humacyte.com), received FDA approval for an investigational new drug application to conduct a multicenter clinical trial to assess safety and efficacy of its innovative bioengineered blood vessel to provide vascular access for dialysis in end-stage renal disease patients. Primary end points of this study will be safety and efficacy of the vessels at 6 months. A multicenter, first-in-human pilot study is under way in Poland to evaluate the safety and efficacy of bioengineered vessels for dialysis access. An independent safety review board completed its planned review of 3-month safety data for the bioengineered blood vessels and concluded that there were no safety issues and that enrollment of additional patients should continue.InVivo TherapeuticsInVivo Therapeutics, MA, USA (www.invivotherapeutics.com), received FDA investigational device exemption to begin human studies to test its biopolymer scaffold product, a technology developed to treat patients with acute, traumatic spinal cord injury.NeuralstemNeuralstem, MD, USA (www.neuralstem.com), has received approval from the FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis. This Phase II trial is designed to treat up to 15 patients, in five different dosing cohorts. Phase I started with five injection sites per patient, and advanced to a maximum of 15 injections of 100,000 cells each. In Phase II, the dosage will advance up to a maximum of 40 injections, and 400,000 cells per injection based on safety. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT01348451).Regentis BiomaterialsRegentis Biomaterials, Israel (www.regentis.co.il), received European CE Mark approval for the GelrinC biodegradable orthopedic implant. The implant is designed to fill cartilage lesions with acellular material so cartilage will regenerate in the knee in the exact shape as the defect, according to the news release. For any traumatic knee injuries, GelrinC can be inserted as a liquid and converted to a solid through UV light to ultimately relieve patient joint pain. Regentis is currently conducting clinical trials in Europe with its investigational version of GelrinC. Further information about this clinical trial is available at www.clinicaltrials.gov (ID: NCT00989794).TengionThe Medical Products Agency in Sweden (www.lakemedelsverket.se/english), accepted Tengion’s (NC, USA; www.tengion.com) clinical trial application to initiate a Phase I clinical trial to evaluate the safety and delivery of its Neo-Kidney Augment™ product in up to five patients with advanced chronic kidney disease.TiGenix NVTiGenix NV, Belgium (www.tigenix.com), was informed by the Spanish health authority that its cartilage repair therapy ChondroCelect® will obtain national reimbursement in Spain. ChondroCelect is the first and, currently, the only cell therapy that has been granted market authorization by the EU in accordance with the Advanced Therapy Medicinal Product regulation EC1394/2007.▪ ReportsIn the UK, a new Parliamentary report on the past, present and future of stem cell research and cell-based therapies has been published [101].▪ AcquisitionsThermo Fisher Scientific & Life Technologies CorporationThermo Fisher Scientific, MA, USA (www.thermofisher.com), the world leader in serving science, and Life Technologies Corporation, CA, USA (www.lifetechnologies.com), have signed a definitive agreement under which Thermo Fisher will acquire Life Technologies for US$76.00 in cash per fully diluted common share, or approximately US$13.6 billion, plus the assumption of net debt at close (US$2.2 billion as of year end 2012).Capital Market & Finances▪ Cellular Dynamics International & Coriell InstituteCalifornia Institute for Regenerative Medicine, CA, USA (www.cirm.ca.gov), awarded Cellular Dynamics International, WI, USA (www.cellulardynamics.com), US$16 million to create three iPS cell lines for each of the 3000 healthy and diseased donors. Tissue samples will be taken from patients suffering from Alzheimer’s disease, autism spectrum disorders, liver diseases, cardiovascular diseases, neurodevelopmental disabilities such as cerebral palsy and infantile epilepsy, diseases of the eye or respiratory diseases. Cellular Dynamics will generate the iPS cell lines using the episomal, or footprint-free, reprogramming method they developed.Coriell Institute, NJ, USA (http://ccr.coriell.org), was awarded almost US$10 million to set up and biobank the iPS cell lines, of which Cellular Dynamics will be the primary subcontractor. Coriell Institute will establish a biorepository with proven methods for managing sample collection and tracking, safe storage and capabilities for worldwide distribution of iPS cells generated by Cellular Dynamics.In response to the award, Cellular Dynamics is opening a facility in Novato, CA, leasing space from the Buck Institute for Research on Aging, CA, USA (www.buckinstitute.org). A portion of the space will be subleased to the Coriell Institute for Medical Research to construct a stem cell bank, an activity for which Cellular Dynamics is a subcontractor.▪ Dainippon Sumitomo PharmaDainippon Sumitomo Pharma, Japan (www.ds-pharma.com), will invest approximately $16 million (¥1.5 billion) to take a 5% stake in Retina Institute Japan (http://rijapan.jp), creating an exclusive collaboration designed to develop new treatments toward various disorders based on iPS cells. Retina Institute Japan is one of 23 companies that comprise RIKEN Ventures, aiming to translate discoveries from RIKEN researchers into commercial products. Established in 2011, Retina Institute Japan plans to carry out global clinical trials for a RIKEN-developed method for transplantation of retinal pigment epithelium cells derived from iPS cells.▪ Mesoblast Inc.Mesoblast Inc., Australia (www.mesoblast.com), has completed a private placement of its shares, raising US$176 (A$170) million. Mesoblast now has cash reserves of approximately US$343 (AUS$332) million.▪ ReNeuronReNeuron, UK (www.reneuron.com), has been awarded two separate grants, totaling US$1.86 (GB£1.2) million, from the UK Biomedical Catalyst to pursue further development of two of its core stem cell therapy candidates. The Biomedical Catalyst is a program of public funding jointly managed by the Technology Strategy Board, the UK’s innovation agency and the Medical Research Council (UK). The scheme is designed to deliver effective support for the best life science opportunities arising in the UK, enabling businesses and academics to speed up the translation of scientific ideas into commercial propositions.In follow-up news, ReNeuron announced that is received regulatory and ethical approval to commence a Phase I clinical trial in the UK with its ReN009 stem cell therapy program targeting the major unmet medical need of critical limb ischemia.In addition, following a further positive assessment from the independent data safety monitoring board for the study, the final dose cohort in the ongoing PISCES Phase I clinical trial with ReN001 in stroke therapy has now been treated and the final patient dosed in the study has been discharged from hospital.ReNeuron and the UK center of translational excellence Catapult (http://ct.catapult.org.uk/) signed an agreement to work together on ReNeuron’s lead CTX stem cell line. Catapult will contribute US$2.0 (GB£1.3) million into the collaboration, to be provided in the form of expert knowledge, plus state-of-the-art laboratories, equipment and services, while ReNeuron will also provide facilities, staff and relevant expertise.▪ StemCellsStemCells, CA, USA (www.stemcellsinc.com), has entered into an agreement with the California Institute for Regenerative Medicine, CA, USA, under which the California Institute for Regenerative Medicine will provide approximately US$19.3 million to help fund preclinical development and investigational new drug-enabling activities of the Company’s proprietary HuCNS-SC® product candidate (purified human neural stem cells) for Alzheimer’s disease. The funding, which will be in the form of a forgivable loan, was awarded under the California Institute for Regenerative Medicine’s Disease Team Therapy Development Award program (RFA 10-05) in September 2012. The goal of the research will be to file an investigational new drug application with the FDA within 4 years.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial 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 Gonzalez R, Garitaonandia I, Abramihina T et al. Deriving dopaminergic neurons for clinical use. A practical approach. Sci. Rep.3,1463 (2013).Crossref, Medline, CAS, Google Scholar2 Wolfraim LA, Takahara M, Viley AM et al. 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Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial. Dermatol. Surg. doi:10.1111/dsu.12204 (2013) (Epub ahead of print).Medline, Google Scholar101 POST Report March 2013. Stem cell research. www.parliament.uk/documents/post/17459%20Houses%20of%20Parliament.pdf (Accessed 30 April 2013)Google ScholarFiguresReferencesRelatedDetails Vol. 8, No. 4 Follow us on social media for the latest updates Metrics History Published online 4 July 2013 Published in print July 2013 Information© Future Medicine LtdFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial 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.PDF download