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| More Info on Palo Alto Institute Grant
May 1, 2010 at 3:47 PM
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| Stanford University shed some light on a basic biology grant approved earlier this week for a researcher linked to the Palo Institute for Research and Education.
Here is what Stanford said in a news release about grants involving the school:
"A fourth Stanford researcher also received funds from CIRM, but the funds will flow through a different organization. Tony Wyss-Coray(at right), PhD, | | |
| Modest Coverage of Wechsler-Reya Recruitment
May 1, 2010 at 8:17 AM
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| The San Diego Union-Tribune has picked up on the story that a Duke cancer stem cell researcher is being recruited to its fair city with the help of a nearly $6 million grant from the California stem cell agency.
Gary Robbins had a brief item yesterday on Robert Wechsler-Reya being courted by the Sanford-Burnham Institute, which is actually in La Jolla, just north of San Diego but totally | | |
| Mechanical dissociation of swine liver to produce organoid units for tissue engineering and in vitro disease modeling.
May 1, 2010 at 6:44 AM
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| | Mechanical dissociation of swine liver to produce organoid units for tissue engineering and in vitro disease modeling. Artif Organs. 2010 Jan;34(1):75-8 Authors: Irani K, Pomerantseva I, Hart AR, Sundback CA, Neville CM, Vacanti JP The complex intricate architecture of the liver is crucial to hepatic function. Standard protocols used for enzymatic digestion to isolate hepatocytes destroy tissue structure and result in significant loss of synthetic, metabolic, and detoxification processes. We describe a process using mechanical dissociation to generate hepatic organoids with preserved intrinsic tissue architecture from swine liver. Oxygen-supplemented perfusion culture better preserved organoid viability, morphology, serum protein synthesis, and urea production, compared with standard and oxygen-supplemented static culture. Hepatic organoids offer an alternative source for hepatic assist devices, engineered liver, disease modeling, and xenobiotic testing. PMID: 20432518 [PubMed - in process] | | |
| Factors Affecting the Longevity and Strength in an In Vitro Model of the Bone-Ligament Interface.
May 1, 2010 at 6:44 AM
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| | Factors Affecting the Longevity and Strength in an In Vitro Model of the Bone-Ligament Interface. Ann Biomed Eng. 2010 Apr 30; Authors: Paxton JZ, Donnelly K, Keatch RP, Baar K, Grover LM The interfaces between musculoskeletal tissues with contrasting moduli are morphologically and biochemically adapted to allow the transmission of force with minimal injury. Current methods of tissue engineering ligaments and tendons do not include the interface and this may limit the future clinical success of engineered musculoskeletal tissues. This study aimed to use solid brushite cement anchors to engineer intact ligaments from bone-to-bone, creating a functional musculoskeletal interface in vitro. We show here that modifying anchor shape and cement composition can alter both the longevity and the strength of an in vitro model of the bone-ligament interface: with values reaching 23 days and 21.6 kPa, respectively. These results validate the use of brushite bone cement to engineer the bone-ligament interface in vitro and raise the potential for future use in ligament replacement surgery. PMID: 20431953 [PubMed - as supplied by publisher] | | |
| The use of mesenchymal stem cells in collagen-based scaffolds for tissue-engineered repair of tendons.
May 1, 2010 at 6:44 AM
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| | The use of mesenchymal stem cells in collagen-based scaffolds for tissue-engineered repair of tendons. Nat Protoc. 2010;5(5):849-63 Authors: Butler DL, Gooch C, Kinneberg KR, Boivin GP, Galloway MT, Nirmalanandhan VS, Shearn JT, Dyment NA, Juncosa-Melvin N Tendon and ligament injuries are significant contributors to musculoskeletal injuries. Unfortunately, traditional methods of repair are not uniformly successful and can require revision surgery. Our research is focused on identifying appropriate animal injury models and using tissue-engineered constructs (TECs) from bone-marrow-derived mesenchymal stem cells and collagen scaffolds. Critical to this effort has been the development of functional tissue engineering (FTE). We first determine the in vivo mechanical environment acting on the tissue and then precondition the TECs in culture with aspects of these mechanical signals to improve repair outcome significantly. We describe here a detailed protocol for conducting several complete iterations around our FTE 'road map.' The in vitro portion, from bone marrow harvest to TEC collection, takes 54 d. The in vivo portion, from TEC implantation to limb harvest, takes 84 d. One complete loop around the tissue engineering ! road map, as presented here, takes 138 d to complete. PMID: 20431531 [PubMed - in process] | | |
| The Enhancement of human embryonic stem cell osteogenic differentiation with nano-fibrous scaffolding.
May 1, 2010 at 6:44 AM
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| | The Enhancement of human embryonic stem cell osteogenic differentiation with nano-fibrous scaffolding. Biomaterials. 2010 Apr 27; Authors: Smith LA, Liu X, Hu J, Ma PX Human embryonic stem cells (hESC) hold great promise as a cell source for tissue engineering since they possess the ability to differentiate into any cell type within the body. However, much work must still be done to control the differentiation of the hESC to the desired lineage. In this study, we examined the effects of the nanofibrous (NF) architecture in both two-dimensional (2-D) poly(l-lactic acid) (PLLA) thin matrices and 3-D PLLA scaffolds in vitro to assess their affect on the osteogenic differentiation of hESC in vitro compared to more traditional solid films and solid-walled (SW) scaffolds. In 2-D culture, hESC on NF thin matrices were found to express collagen type 1, Runx2, and osteocalcin mRNA of higher levels than the hESC on the solid films after 1 week of culture and increased mineralization was observed on the NF matrices compared to the solid films after 3 weeks of culture. After 6 weeks of 3-D culture, the hESC on the NF scaffolds expressed sig! nificantly more osteocalcin mRNA compared to these on the SW scaffolds. The data indicates that the NF architecture enhances the osteogenic differentiation of the hESC compared to more traditional scaffolding architecture. PMID: 20430439 [PubMed - as supplied by publisher] | | |
| Intervertebral disc regeneration after implantation of a cell-free bioresorbable implant in a rabbit disc degeneration model.
May 1, 2010 at 6:44 AM
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| | Intervertebral disc regeneration after implantation of a cell-free bioresorbable implant in a rabbit disc degeneration model. Biomaterials. 2010 Apr 27; Authors: Endres M, Abbushi A, Thomale UW, Cabraja M, Kroppenstedt SN, Morawietz L, Casalis PA, Zenclussen ML, Lemke AJ, Horn P, Kaps C, Woiciechowsky C Degeneration of the intervertebral disc is the most common cause of lower back pain. Interestingly, all available treatments are limited to treat the symptoms and not the underlying biologic alterations of the disc. Freeze-dried resorbable non-woven polyglycolic acid (PGA) - hyaluronan implants were used in a degenerated disc disease (DDD) model in New Zealand white rabbits. The constructs were immersed in allogenic serum and implanted into the disc defect. Animals with discectomy only served as controls. The T2-weighted/fat suppression sequence signal intensity of the operated discs as assessed by magnet resonance imaging decreased in both groups one week after the operation compared to a healthy disc. After 12 months the implanted group showed an increase of 51% in the signal intensity compared to the 1-week results whereas the signal intensity in the sham group remained on the same level from one week to 12 months. Histological and quantitative immunohistochemi! cal examination after 12 months indicated cell migration into the defect and showed formation of disc repair tissue. In controls, repair tissue containing type II collagen was not evident. In conclusion, the implantation of polymer-based constructs after discectomy induces tissue regeneration resulting in improvement of the disc water content. PMID: 20430435 [PubMed - as supplied by publisher] | | |
| Future approaches for inner ear protection and repair.
May 1, 2010 at 6:44 AM
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| | Future approaches for inner ear protection and repair. J Commun Disord. 2010 Apr 8; Authors: Shibata SB, Raphael Y Health care professionals tending to patients with inner ear disease face inquiries about therapy options, including treatments that are being developed for future use but not yet available. The devastating outcome of sensorineural hearing loss, combined with the permanent nature of the symptoms, make these inquiries demanding and frequent. The vast information accessible online and the publicity for breakthroughs in research add to patient requests for access to advanced and innovative therapies, even before these are available for clinical use. This can sometimes be taxing on the health care provider who is in contact with the patients. Here we aim to equip the provider with information about some of the progress made for protective and reparative approaches for treating inner ears. Learning outcomes: (1) Readers will be able to explain why hearing loss is irreversible and common, (2) readers will be able to explain the importance of protective measures and the ! progress made in discovery and design of novel biological protective molecules, (3) readers will be able to describe reparative approaches currently under investigation (such as tissue engineering), the main difficulties in the design of such therapies and the major hurdles that remain for making novel technologies clinically viable, and (4) readers will be able to explain to their patients some of the progress in developing new treatments without making the promise of imminent clinical use. With this information, readers will be able to guide patients to make better choices for their treatment and to guide students toward research in this exciting field. PMID: 20430401 [PubMed - as supplied by publisher] | | |
| Biological definition of multiple chemical sensitivity from redox state and cytokine profiling and not from polymorphisms of xenobiotic-metabolizing enzymes.
May 1, 2010 at 6:44 AM
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| | Biological definition of multiple chemical sensitivity from redox state and cytokine profiling and not from polymorphisms of xenobiotic-metabolizing enzymes. Toxicol Appl Pharmacol. 2010 Apr 26; Authors: De Luca C, Scordo MG, Cesareo E, Pastore S, Mariani S, Maiani G, Stancato A, Loreti B, Valacchi G, Lubrano C, Raskovic D, De Padova L, Genovesi G, Korkina LG BACKGROUND: Multiple chemical sensitivity (MCS) is a poorly clinically and biologically defined environment-associated syndrome. Although dysfunctions of phase I / phase II metabolizing enzymes and redox imbalance have been hypothesized, corresponding genetic and metabolic parameters in MCS have not been systematically examined. OBJECTIVES: We sought for genetic, immunological, and metabolic markers in MCS. METHODS: We genotyped patients with diagnosis of MCS, suspected MCS and Italian healthy controls for allelic variants of cytochrome P450 isoforms (CYP2C9, CYP2C19, CYP2D6, and CYP3A5), UDP-glucuronosyl transferase (UGT1A1), and glutathione S-transferases (GSTP1, GSTM1, and GSTT1). Erythrocyte membrane fatty acids, antioxidant (catalase, superoxide dismutase (SOD)) and glutathione metabolizing (GST, glutathione peroxidase (Gpx)) enzymes, whole blood chemiluminescence, total antioxidant capacity, levels of nitrites/nitrates, glutathione, HNE-protein adducts, and ! a wide spectrum of cytokines in the plasma were determined. RESULTS: Allele and genotype frequencies of CYPs, UGT, GSTM, GSTT, and GSTP were similar in the Italian MCS patients and in the control populations. The activities of erythrocyte catalase and GST were lower, whereas Gpx was higher than normal. Both reduced and oxidised glutathione were decreased, whereas nitrites/nitrates were increased in the MCS groups. The MCS fatty acid profile was shifted to saturated compartment and IFNgamma, IL-8, IL-10, MCP-1, PDGFbb, and VEGF were increased. CONCLUSIONS: Altered redox and cytokine patterns suggest inhibition of expression/activity of metabolizing and antioxidant enzymes in MCS. Metabolic parameters indicating accelerated lipid oxidation, increased nitric oxide production and glutathione depletion in combination with increased plasma inflammatory cytokines should be considered in biological definition and diagnosis of MCS. PMID: 20430047 [PubMed - as supplied by publisher] | | |
| WNT5A induces osteogenic differentiation of human adipose stem cells via rho-associated kinase Rock.
May 1, 2010 at 6:44 AM
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| | WNT5A induces osteogenic differentiation of human adipose stem cells via rho-associated kinase Rock. Cytotherapy. 2010 Apr 29; Authors: Santos A, Bakker AD, Blieck-Hogervorst JM, Klein-Nulend J Abstract Background aims. Human (h) adipose tissue-derived mesenchymal stromal cells (ASC) constitute an interesting cellular source for bone tissue engineering applications. Wnts, for example Wnt5a, are probably important regulators of osteogenic differentiation of stem cells, but the role of Wnt5a in hASC lineage commitment and the mechanisms activated upon Wnt5a binding are unknown. We examined whether Wnt5a induces osteogenic and/or adipogenic differentiation of hASC. Methods. hASC were incubated for 7 days with or without Wnt5a, rho-associated kinase (ROCK)-activity inhibitor Y27632 or Wnt3a. Cells were lysed for total RNA isolation, DNA content and alkaline phosphatase (ALP) activity. Mineralized nodule formation and gene expression of osteogenic markers osteocalcin and runt-related protein-2 (RUNX2), and adipogenic markers peroxisome proliferator activator receptor-gamma (PPARgamma) and transcription factor apetala-2 (aP2), were analyzed. hASC were incubate! d with Wnt5a or Wnt3a to determine activation of canonical and/or non-canonical Wnt signaling pathways, and protein kinase C activity (PKC), total beta-catenin content and gene expression of connexin 43 and cyclin D1 were quantified. Results. Wnt5a increased ALP activity and RUNX2 and osteocalcin gene expression, and down-regulated adipogenic markers through ROCK activity. Wnt5a also induced mineralized nodule formation. Wnt3a only enhanced RUNX2 and osteocalcin gene expression, and did not induce osteogenic differentiation. Wnt5a activated the non-canonical Wnt signaling pathway by increasing PKC activity, while Wnt3a mildly activated the Wnt canonical pathway by increasing total beta-catenin content and connexin 43 and cyclin D1 gene expression. Conclusions. Our data illustrate the importance of Wnt5a as a stimulator of hASC osteogenic differentiation, and show that changes in actin cytoskeleton controlled by ROCK are determinants for Wnt5a-induced osteogenic differentiat! ion of hASC. PMID: 20429785 [PubMed - as supplied by publisher] | | |
| Reinforcing poly(epsilon-caprolactone) nanofibers with cellulose nanocrystals.
May 1, 2010 at 6:44 AM
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| | Reinforcing poly(epsilon-caprolactone) nanofibers with cellulose nanocrystals. ACS Appl Mater Interfaces. 2009 Sep;1(9):1996-2004 Authors: Zoppe JO, Peresin MS, Habibi Y, Venditti RA, Rojas OJ We studied the use of cellulose nanocrystals (CNXs) obtained after acid hydrolysis of ramie cellulose fibers to reinforce poly(epsilon-caprolactone) (PCL) nanofibers. Chemical grafting with low-molecular-weight PCL diol onto the CNXs was carried out in an attempt to improve the interfacial adhesion with the fiber matrix. Grafting was confirmed via infrared spectroscopy and thermogravimetric analyses. The polymer matrix consisted of electrospun nanofibers that were collected as nonwoven webs. The morphology as well as thermal and mechanical properties of filled and unfilled nanofibers were elucidated by scanning electron microscopy, differential scanning calorimetry, and dynamic mechanical analysis, respectively. The addition of CNXs into PCL produced minimal changes in the thermal behavior of the electrospun fibers. However, a significant improvement in the mechanical properties of the nanofibers after reinforcement with unmodified CNXs was confirmed. Fiber webs f! rom PCL reinforced with 2.5% unmodified CNXs showed ca. 1.5-fold increase in Young's modulus and the ultimate strength compared to PCL webs. Compared to the case of grafted nanocrystals, the unmodified ones imparted better morphological homogeneity to the nanofibrillar structure. The grafted nanocrystals had a negative effect on the morphology of nonwoven webs in which individual nanofibers became annealed during the electrospinning process and, therefore, could not be compared to neat PCL nonwoven webs. A rationalization for the different effects of grafted and unmodified CNXs in reinforcing PCL nanofibers is provided. PMID: 20355825 [PubMed - indexed for MEDLINE] | | |
| The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency.
May 1, 2010 at 6:44 AM
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| | The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):20-3 Authors: Carr M On 15 December 2005, the European Medicines Agency (EMEA) launched an "SME Office" to provide financial and administrative assistance to micro-, small- and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs. According to current EU definition of an SME, companies with fewer than 250 employees, and an annual turnover of not more than 50 million euro or an annual balance sheet total of not more than 43 million euro, are eligible for assistance from the SME Office. Incentives available from the EMEA for SMEs, include: Administrative and procedural assistance from SME Office within the Agency; Fee reductions (90%) for scientific advice and inspections; Fee exemptions for certain administrative services (excluding parallel distribution); Deferral of the fee payable for an application for marketing authorisation or related inspection until after the grant of the marketing autho! risation; Conditional fee exemption where scientific advice followed and marketing application is unsuccessful; Assistance with translations of the product information documents. At the end of May 2009, more than 380 companies from 21 countries across the European Economic Area (EEA) had SME status assigned by the EMEA. The large majority of companies are developing medicinal products for human use, 16 are veterinary companies, 15 companies are developing products for both human and veterinary use and 38 are regulatory consultants. Since the SME initiative started the Agency has processed more than 130 requests for scientific advice with fee reductions totalling of 6.9 million euro. Regulatory assistance has been provided to more than 170 companies and 12 companies have benefited from the SME translation service. Stakeholders have acknowledged the significant role the SME Office now plays as a service provider. In the period between January 2006 and June 2009, 34 applicatio! ns for marketing authorization from SME applicants were filed ! for medi cinal products for human use. Current analysis shows SMEs to have a lower success rate compared to non-SME companies. Major objections for SMEs are particularly high in the area of quality. Although the SME initiative is still at an early stage, it is apparent from the experience gained with applications for marketing authorisation to date that it is important for companies to open up an early dialogue with the EMEA. Scientific advice should be sought early, proactively and comprehensively on key issues in development (quality, non-clinical, clinical) and follow-up advice should be sought as development proceeds. For advanced therapy medicinal products, the assistance available to SMEs will be reinforced in 2009, with the introduction of the certification process. PMID: 20101799 [PubMed - indexed for MEDLINE] | | |
| CAT--the new committee for advanced therapies at the European Medicines Agency.
May 1, 2010 at 6:44 AM
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| | CAT--the new committee for advanced therapies at the European Medicines Agency. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):9-13 Authors: Celis P The Regulation on Advanced Therapies (Regulation (EC) 1394/2007) establishes a new scientific committee, the Committee for Advanced Therapies (CAT), at the European Medicines Agency. The CAT is composed of experts in the field of Advanced Therapy Medicinal Products (ATMPs)--gene and cell therapy and tissue engineered products--and is responsible for the evaluation of the marketing authorisation applications for this novel class of products. The CAT is also involved in all scientific advice on ATMPs and in two new regulatory procedures for ATMPs, the classification and the certification procedures. The CAT will also play a key role in early contacts with developers of ATMPs. PMID: 20084354 [PubMed - indexed for MEDLINE] | | |
| [Regulation (EC) No. 1394/2007 on advanced therapy medicinal products : Incorporation into national law]
May 1, 2010 at 6:44 AM
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| | [Regulation (EC) No. 1394/2007 on advanced therapy medicinal products : Incorporation into national law] Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):14-9 Authors: Dwenger A, Strassburger J, Schwerdtfeger W Regulation (EC) No. 1394/2007 has created a new legal framework for advanced therapy medicinal products (gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products). The Regulation is directly applicable in the Member States of the European Union and, in principle, requires no incorporation into national law. However, the amendment of Directive 2001/83/EC, which results from Regulation (EC) No. 1394/2007, has created a need for incorporation into and amendment of the German Medicinal Products Act. This is one of the objectives of the 15th amendment of the German Medicinal Products Act. In particular, the definition "advanced therapy medicinal products" and the special provisions for advanced therapy medicinal products prepared on a non-routine basis, which are based on the special provisions contained in Art. 28 No. 2 of Regulation (EC) No. 1394/2007, are to be incorporated into the German Medicinal Products Act. These ! special provisions will be explained in detail. PMID: 20033662 [PubMed - indexed for MEDLINE] | | |
| [Problems in microbial safety of advanced therapy medicinal products. Squaring the circle]
May 1, 2010 at 6:44 AM
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| | [Problems in microbial safety of advanced therapy medicinal products. Squaring the circle] Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):45-51 Authors: Montag-Lessing T, Störmer M, Schurig U, Brachert J, Bubenzer M, Sicker U, Beshir R, Spreitzer I, Löschner B, Bache C, Becker B, Schneider CK Today, sterility of parenteral drugs is practically guaranteed. Well-defined procedures in the pharmaceutical industry enable effective protection against contamination by bacteria and fungi. In contrast, problems regarding microbial safety of advanced therapy medicinal products (ATMPs), especially of cell therapeutics, are at best only partially solved. The latter should be understood as a challenge for manufacturers, regulators, and physicians. Many of the manufacturing principles mentioned above are not applicable in production of cell therapeutics. Sterility of source materials cannot be guaranteed and the hitherto known procedures for sterilization are, as a rule, not feasible. Thus, the sterility of the final product cannot be guaranteed. Considering the extremely short shelf life of many cell therapeutics, sometimes only a few hours, the results from established methods for sterility testing are often available too late. Furthermore, the sterility of a test! sample does not indicate sterility of the whole product. In most cases, conventional methods for pyrogen testing are not applicable for ATMPs. This paper demonstrates relevant limitations regarding microbial safety and pyrogenicity. Possibilities to overcome these problems are discussed and some novel solutions are proposed. PMID: 20012926 [PubMed - indexed for MEDLINE] | | |
| [Clinical trials with advanced therapy medicinal products]
May 1, 2010 at 6:44 AM
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| | [Clinical trials with advanced therapy medicinal products] Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):68-74 Authors: Schüssler-Lenz M, Schneider CK For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challen! ges with advanced therapies. PMID: 20011994 [PubMed - indexed for MEDLINE] | | |
| Legal basis of the Advanced Therapies Regulation.
May 1, 2010 at 6:44 AM
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| | Legal basis of the Advanced Therapies Regulation. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):4-8 Authors: Jekerle V, Schröder C, Pedone E Advanced therapy medicinal products consist of gene therapy, somatic cell therapy and tissue engineered products. Due to their specific manufacturing process and mode of action these products require specially tailored legislation. With Regulation (EC) No. 1394/2007, these needs have been met. Definitions of gene therapy, somatic cell therapy and tissue engineered products were laid down. A new committee, the Committee for Advanced Therapies, was founded, special procedures such as the certification procedure for small- and medium-sized enterprises were established and the technical requirements for Marketing Authorisation Applications (quality, non-clinical and clinical) were revised. PMID: 19940965 [PubMed - indexed for MEDLINE] | | |
| Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.
May 1, 2010 at 6:44 AM
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| | Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):24-9 Authors: Salmikangas P, Flory E, Reinhardt J, Hinz T, Maciulaitis R The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been dev! eloped to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed. PMID: 19940964 [PubMed - indexed for MEDLINE] | | |
| Intrastriatal transplantation of GDNF-engineered BMSCs and its neuroprotection in lactacystin-induced Parkinsonian rat model.
May 1, 2010 at 6:44 AM
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| | Intrastriatal transplantation of GDNF-engineered BMSCs and its neuroprotection in lactacystin-induced Parkinsonian rat model. Neurochem Res. 2010 Mar;35(3):495-502 Authors: Wu J, Yu W, Chen Y, Su Y, Ding Z, Ren H, Jiang Y, Wang J The potential value of glial cell line-derived neurotrophic factor (GDNF) in treating Parkinson's disease (PD) remains controversial. In order to evaluate the therapeutic effect of GDNF-engineered bone marrow stromal cells (BMSCs) in parkinsonian rat model, GDNF-BMSCs and LacZ-BMSCs were transplanted into striatum and followed by Lactacystin lesioning at median forebrain bundles 1 week later. We observed that the intrastriatal transplantation of GDNF-BMSCs could significantly rescue the dopaminergic neurons from lactacystin-induced neurotoxicity with regard to behavioral recovery, tyrosine hydroxylase level in nigra and striatum, and striatal dopamine level. We interpret the outcomes that intrastriatal transplantation of GDNF-BMSCs might be beneficial in the treatment of PD. PMID: 19894114 [PubMed - indexed for MEDLINE] | | |
| [Construction of recombinant adenovirus including microdystrophin and expression in the mesenchymal cells of mdx mice]
May 1, 2010 at 6:44 AM
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| | [Construction of recombinant adenovirus including microdystrophin and expression in the mesenchymal cells of mdx mice] Sheng Wu Gong Cheng Xue Bao. 2007 Jan;23(1):27-32 Authors: Xiong F, Zhang C, Xiao SB, Li MS, Wang SH, Yu MJ, Shang YC Construction of recombinant adenovirus, which contain human microdystrophin, and then transfection into mesenchymal cells( MSCs) of mdx mice were done, and genetically-corrected isogenic MSCs were acquired; the MSCs transplantation into the mdx mice was then done to treat the Duchenne muscular dystrophy( DMD). Microdystrophin cDNA was obtained from recombinant plasmid pBSK-MICRO digested with restrictive endonuclease Not I ; the production was inserted directionally into pShuttle-CMV. The plasmid of pShuttle-CMV-MICRO was digested by Pme I , the fragment containing microdystrophin was reclaimed and transfected into E. coli BJ5183 with plasmid pAdeasy-1. After screening by selected media, the extracted plasmid of positive bacteria was transfected into HEK293 cells with liposome and was identified by observing the CPE of cells and by the PCR method. Finally, MSCs of mdx mice were infected with the culture media containing recombinant adenovirus, and the expression o! f microdystrophin was detected by RT-PCR and immunocytochemistry. Recombinant adenovirus including microdystrophin was constructed successfully and the titer of recombinant adenovirus was about 5.58 x 10(12) vp/mL. The recombinant adenovirus could infect MSC of mdx mice and microdystrophin could be expressed in the MSC of mdx mice. Recombinant adenovirus including microdystrophin was constructed successfully, and the microdystrophin was expressed in the MSC of mdx mice. This lays the foundation for the further study of microdystrophin as a target gene to correct the dystrophin-defected MSC for stem cell transplantation to cure DMD. PMID: 17366884 [PubMed - indexed for MEDLINE] | | | | 
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