Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

Abstract:

:In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

journal_name

Regen Med

journal_title

Regenerative medicine

authors

Sheth-Shah R,Vernon AJ,Seetharaman S,Neale MH,Daniels JT

doi

10.2217/rme-2015-0020

subject

Has Abstract

pub_date

2016-04-01 00:00:00

pages

307-20

issue

3

eissn

1746-0751

issn

1746-076X

journal_volume

11

pub_type

杂志文章
  • In vitro potential of human mesenchymal stem cells for corneal epithelial regeneration.

    abstract::Aim: To determine the potential of mesenchymal stem cells (MSC) for corneal epithelial regeneration in vitro. Materials & methods: Bone marrow MSC (BM-MSC) and adipose tissue MSC were analyzed for corneal epithelial and mesenchymal markers, using limbal stem cells and corneal cells as controls. MSC with better potenti...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2019-0067

    authors: Nieto-Nicolau N,Martín-Antonio B,Müller-Sánchez C,Casaroli-Marano RP

    更新日期:2020-03-01 00:00:00

  • The UK Stem Cell Bank: a UK government-funded, international resource center for stem cell research.

    abstract::The UK Stem Cell Bank is a UK Research Council-funded initiative that aims to provide ethically sourced and quality controlled stocks of cells for researchers and also establish seed stocks of cell lines for clinical trials. Whilst the Bank is prohibited from carrying out basic stem cell research (to avoid conflicts o...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/17460751.1.1.139

    authors: Stacey G,Hunt CJ

    更新日期:2006-01-01 00:00:00

  • Regulatory considerations for the development of autologous induced pluripotent stem cell therapies.

    abstract::Induced pluripotent stem (iPS) cells offer tremendous opportunity for the creation of autologous cellular therapies, in which gene correction or the avoidance of immune response issues are desirable. In addition, iPS cells avoid the ethical concerns raised by the sourcing of human embryonic stem cells (hESCs) from emb...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme.10.55

    authors: Carpenter MK,Couture LA

    更新日期:2010-07-01 00:00:00

  • Construction of a functional thymic microenvironment from pluripotent stem cells for the induction of central tolerance.

    abstract::The thymus is required for generation of a self-tolerant, self-restricted T-cell repertoire. The capacity to manipulate or replace thymus function therapeutically would be beneficial in a variety of clinical settings, including for improving recovery following bone marrow transplantation, restoring immune system funct...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.15.8

    authors: Bredenkamp N,Jin X,Liu D,O'Neill KE,Manley NR,Blackburn CC

    更新日期:2015-01-01 00:00:00

  • Repurposing nano-enabled polymeric scaffolds for tumor-wound management and 3D tumor engineering.

    abstract::The main challenges of cancer drugs are toxicity, effect on wound healing/patient outcome and in vivo instability. Polymeric scaffolds have been used separately for tissue regeneration in wound healing and as anticancer drug releasing devices. Bringing these two together in bifunctional scaffolds can provide a tool fo...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2020-0072

    authors: Goonoo N,Boodhun A,Ziman M,Gray E,Bhaw-Luximon A

    更新日期:2020-10-01 00:00:00

  • Implications of multipotent mesenchymal stromal cell aging.

    abstract::Aging is defined as the progressive and generalized impairment of function, resulting in an increasing vulnerability to environmental challenges and a growing risk of disease and death. The decline in the regenerative capacity of resident stem cells across different tissues is a central mediator of aging. In this pape...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.13.10

    authors: Stochaj U,Kodiha M,Shum-Tim D,Colmegna I

    更新日期:2013-03-01 00:00:00

  • Development of cell therapy strategies to overcome copper toxicity in the LEC rat model of Wilson disease.

    abstract:AIMS:Therapeutic replacement of organs with healthy cells requires disease-specific strategies. As copper toxicosis due to ATP7B deficiency in Wilson disease produces significant liver injury, disease-specific study of transplanted cell proliferation will offer insights into cell and gene therapy mechanisms. MATERIALS...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/17460751.3.2.165

    authors: Malhi H,Joseph B,Schilsky ML,Gupta S

    更新日期:2008-03-01 00:00:00

  • Organization profile: genetics policy institute.

    abstract::Genetics Policy Institute (GPI) is a nonprofit, public interest organization recognized as a leading promoter and defender of stem cell research and other cutting-edge medical research targeting cures. Since GPI's inception in 2003, its mission has focused on establishing a positive policy, regulatory and societal fra...

    journal_title:Regenerative medicine

    pub_type: 新闻

    doi:10.2217/rme.09.6

    authors: Siegel B

    更新日期:2009-05-01 00:00:00

  • Induced pluripotent stem cells in regenerative medicine: an argument for continued research on human embryonic stem cells.

    abstract::Human embryonic stem cells (ESCs) can be induced to differentiate into a wide range of tissues that soon could be used for therapeutic applications in regenerative medicine. Despite their developmental potential, sources used to generate human ESC lines raise serious ethical concerns, which recently prompted efforts t...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.09.46

    authors: Lee H,Park J,Forget BG,Gaines P

    更新日期:2009-09-01 00:00:00

  • Autologous cell therapies: the importance of regulatory oversight.

    abstract::Promising new medical technologies and approaches to treatment offer the potential to substantially improve the lives of patients who need help, and in some cases transform the way medicine is practiced. In recent years, the biotechnology industry has generated many examples of new approaches that are having a profoun...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme.12.90

    authors: Werner M,Mayleben T,Van Bokkelen G

    更新日期:2012-11-01 00:00:00

  • Periadventitial adipose-derived stem cell treatment halts elastase-induced abdominal aortic aneurysm progression.

    abstract:AIM:Demonstrate that periadventitial delivery of adipose-derived mesenchymal stem cells (ADMSCs) slows aneurysm progression in an established murine elastase-perfusion model of abdominal aortic aneurysm (AAA). MATERIALS & METHODS:AAAs were induced in C57BL/6 mice using porcine elastase. During elastase perfusion, a de...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme.14.61

    authors: Blose KJ,Ennis TL,Arif B,Weinbaum JS,Curci JA,Vorp DA

    更新日期:2014-01-01 00:00:00

  • Methods and practices to diversify cell-based products.

    abstract::Medicinal signaling cell (MSC)-based products represent emerging treatments in various therapeutic areas including cardiometabolic, inflammation, autoimmunity, orthopedics, wound healing and oncology. Exploring innovation beyond minimally manipulated plastic-adherent ex vivo expanded allogeneic MSCs enables product de...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2017-0093

    authors: Vertès AA

    更新日期:2017-12-01 00:00:00

  • A xenobiotic-free culture system for human limbal epithelial stem cells.

    abstract:AIMS:Murine 3T3 feeder cells are commonly used for stem cell expansion. Although 'feeder-free' systems are being developed for a variety of stem cells including embryonic, the use of feeder cells currently remains optimal for the expansion of epithelial stem cells. In this study, MRC-5, a human embryonic fibroblast cel...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/17460751.2.6.919

    authors: Notara M,Haddow DB,MacNeil S,Daniels JT

    更新日期:2007-11-01 00:00:00

  • Short-term outcomes after pure bone marrow aspirate injection for severe knee osteoarthritis: a case series.

    abstract::Background: Bone marrow aspiration (BMA) is among a group of autologous cell-based therapies currently being explored to treat osteoarthritis (OA). Materials & methods: This retrospective case study observed ten patients (13 knees) with severe knee OA who failed extensive conservative treatment and were treated with B...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2019-0113

    authors: Colberg RE,Jurado Vélez JA,Walsh KP,Fleisig G

    更新日期:2020-07-01 00:00:00

  • Cardiac repair and restoration using human embryonic stem cells.

    abstract::Advances in directed differentiation of human embryonic stem cells (hESCs) toward cardiac lineages have generated much interest within the myocardial therapy field. Beyond the promise that hESCs would provide a supply of new cardiomyocytes to the damaged heart, recent studies have also shown that paracrine effects of ...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.12.46

    authors: Bernstein HS

    更新日期:2012-09-01 00:00:00

  • The issue of immunology in stem cell therapies: a pharmaceutical perspective.

    abstract::Cautious approaches in the clinic are currently proposed, supported by relevant in vitro, in vivo and published data. Key to developing our understanding of the risks of immune rejection of stem cell based therapies will be the inclusion of immunological endpoints in clinical trials and the sharing of data. There is l...

    journal_title:Regenerative medicine

    pub_type: 社论

    doi:10.2217/rme.14.50

    authors: Haworth R,Sharpe M

    更新日期:2015-01-01 00:00:00

  • A panel of tests to standardize the characterization of human embryonic stem cells.

    abstract::Human embryonic stem cells offer a renewable source of a wide range of cell types for use in research and cell-based therapies. Characterizing these cells provides important information about their current state and affords relevant details for subsequent downstream manipulation. Prior to considering therapeutic appli...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/17460751.2.2.179

    authors: Pal R,Mandal A,Rao HS,Rao MS,Khanna A

    更新日期:2007-03-01 00:00:00

  • Sherley v. Sebelius.

    abstract::Following the reversal by the court of appeals of the injunction against federal funding of human embryonic stem cell research, Judge Lamberth has held such funding to be lawful and has dismissed the lawsuit. However, the litigation is likely to continue in the court of appeals and ultimately perhaps in the Supreme Co...

    journal_title:Regenerative medicine

    pub_type: 历史文章,杂志文章

    doi:10.2217/rme.11.70

    authors: Goldfarb N

    更新日期:2011-11-01 00:00:00

  • The olfactory mucosa: a potential source of stem cells for hearing regeneration.

    abstract::The olfactory mucosa contains cells that enable it to generate new neurons and other supporting cells throughout life, allowing it to replace cells of the mucosa that have been damaged by exposure to various insults. In this article, we discuss the different types of stem cell found within the olfactory mucosa and the...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme-2018-0009

    authors: Young E,Westerberg B,Yanai A,Gregory-Evans K

    更新日期:2018-07-01 00:00:00

  • Early evaluation and value-based pricing of regenerative medicine technologies.

    abstract::Since the first pioneering scientists explored the potential of using human cells for therapeutic purposes the branch of regenerative medicine has evolved to become a mature industry. The focus has switched from 'what can be done' to 'what can be commercialized'. Timely health economic evaluation supports successful m...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme.13.69

    authors: Koerber F,Rolauffs B,Rogowski W

    更新日期:2013-11-01 00:00:00

  • Leukocyte-rich platelet-rich plasma application in post-traumatic osteoarthritis with popliteal cyst: a case report.

    abstract::Aim: To describe the successful treatment of a Baker's cyst in the setting of post-traumatic osteoarthritis using ultrasound-guided injection of platelet-rich plasma. Setting: Outpatient sports clinic. Patient: 29-year old male basketball player. Case description: The patient presented with 2-months history of right k...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2020-0021

    authors: Song B,Yeh PC,Jayaram P

    更新日期:2020-06-01 00:00:00

  • Isolation of fibroblasts for coating of meshes for reconstructive surgery: differences between mesh types.

    abstract:AIMS:An extensive colonization of surgical meshes with autologous fibroblasts may reduce complications. Therefore, we aimed to establish a technique that allows isolation and propagation of fibroblasts from vaginal biopsies. Using these cells we tested the applicability of several clinically applied meshes for fibrobla...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/17460751.4.2.197

    authors: Skala CE,Petry IB,Gebhard S,Hengstler JG,Albrich SB,Maltaris T,Naumann G,Koelbl H

    更新日期:2009-03-01 00:00:00

  • Using poly(lactide-co-glycolide) electrospun scaffolds to deliver cultured epithelial cells to the cornea.

    abstract:AIMS:To assess the potential of electrospun poly(lactide-co-glycolide) membranes to provide a biodegradable cell carrier system for limbal epithelial cells. MATERIAL & METHODS:50:50 poly(lactide-co-glycolide) scaffolds were spun, sterilized and seeded with primary rabbit limbal epithelial cells. Cells were cultured on...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme.10.16

    authors: Deshpande P,McKean R,Blackwood KA,Senior RA,Ogunbanjo A,Ryan AJ,MacNeil S

    更新日期:2010-05-01 00:00:00

  • Musculoskeletal tissue engineering with human umbilical cord mesenchymal stromal cells.

    abstract::Multipotent mesenchymal stromal cells (MSCs) hold tremendous promise for tissue engineering and regenerative medicine, yet with so many sources of MSCs, what are the primary criteria for selecting leading candidates? Ideally, the cells will be multipotent, inexpensive, lack donor site morbidity, donor materials should...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.10.98

    authors: Wang L,Ott L,Seshareddy K,Weiss ML,Detamore MS

    更新日期:2011-01-01 00:00:00

  • Global update: Germany.

    abstract::Researchers are working on key issues in regenerative medicine in many of the over 280 academic institutions in Germany. Moreover, nonuniversity research institutions such as Helmholtz-, Max-Planck-, Fraunhofer- and Leibniz-Centers provide important contributions to the field of regenerative medicine in Germany. Resea...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.11.64

    authors: Lauter FR,Wirsching S

    更新日期:2011-11-01 00:00:00

  • Identity and ownership issues in the regulation of autologous cells.

    abstract::Clinical application of autologous cells by businesses promoting unproven stem cell treatments represents the largest growth sector in this problematic industry, but also presents special challenges to regulators. Patients frequently identify autologous cells as personal property, using the language of 'ownership'. Th...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2017-0063

    authors: Sipp D

    更新日期:2017-10-01 00:00:00

  • Cell-based therapy approaches: the hope for incurable diseases.

    abstract::Cell therapies aim to repair the mechanisms underlying disease initiation and progression, achieved through trophic effect or by cell replacement. Multiple cell types can be utilized in such therapies, including stem, progenitor or primary cells. This review covers the current state of cell therapies designed for the ...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme.14.35

    authors: Buzhor E,Leshansky L,Blumenthal J,Barash H,Warshawsky D,Mazor Y,Shtrichman R

    更新日期:2014-01-01 00:00:00

  • Muscle-derived stem cells in peripheral nerve regeneration: reality or illusion?

    abstract::Owing to the complicated and time-consuming regenerative process, the repair of injured peripheral nerves depends largely on ongoing stem-cell therapy. Decades ago, researchers successfully isolated and identified muscle-derived stem cells (MDSCs) and discovered their potential for multidifferentiation. MDSCs play an ...

    journal_title:Regenerative medicine

    pub_type: 杂志文章,评审

    doi:10.2217/rme-2016-0165

    authors: Zhou J,Cui H,Lu H,Xu Z,Feng W,Chen L,Jin X,Yang X,Qi Z

    更新日期:2017-04-01 00:00:00

  • Conference Report: 6th Annual International Symposium on Regenerative Rehabilitation.

    abstract::The 6th International Symposium on Regenerative Rehabilitation, hosted by the Alliance for Regenerative Rehabilitation Research and Training (AR3T), included a preconference meeting of institutional representatives of the International Consortium of Regenerative Rehabilitation, keynote talks from distinguished scienti...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2018-0026

    authors: Loghmani MT,Roche JA

    更新日期:2018-06-01 00:00:00

  • Therapeutic efficacy of multipotent adult progenitor cells versus mesenchymal stem cells in experimental autoimmune encephalomyelitis.

    abstract:AIM:In this study, we have evaluated the therapeutic efficacy of mouse multipotent adult progenitor cells (mMAPCs) in experimental autoimmune encephalomyelitis (EAE), an animal model of multiple sclerosis, and compared it with mouse mesenchymal stem cells (mMSCs). MATERIALS & METHODS:We administered PKH26-labeled mMAP...

    journal_title:Regenerative medicine

    pub_type: 杂志文章

    doi:10.2217/rme-2016-0109

    authors: Singh SP,Jadhav SH,Chaturvedi CP,Nityanand S

    更新日期:2017-04-01 00:00:00