Cost-effective master cell bank validation of multiple clinical-grade human pluripotent stem cell lines from a single donor.

Abstract:

:Standardization guidelines for human pluripotent stem cells are still very broadly defined, despite ongoing clinical trials in the U.S., U.K., and Japan. The requirements for validation of human embryonic (hESCs) and induced pluripotent stem cells (iPSCs) in general follow the regulations for other clinically compliant biologics already in place but without addressing key differences between cell types or final products. In order to realize the full potential of stem cell therapy, validation criteria, methodology, and, most importantly, strategy, should address the shortfalls and efficiency of current approaches; without this, hESC- and, especially, iPSC-based therapy will not be able to compete with other technologies in a cost-efficient way. We addressed the protocols for testing cell lines for human viral pathogens and propose a novel strategy that would significantly reduce costs. It is highly unlikely that the multiple cell lines derived in parallel from a tissue sample taken from one donor would have different profiles of endogenous viral pathogens; we therefore argue that samples from the Master Cell Banks of sibling lines could be safely pooled for validation. We illustrate this approach with tiered validation of two sibling clinical-grade hESC lines, KCL033 and KCL034 (stage 1, sterility; stage 2, specific human pathogens; and stage 3, nonspecific human pathogens). The results of all tests were negative. This cost-effective strategy could also be applied for validation of Master Cell Banks of multiple clinical-grade iPSC lines derived from a single donor.

journal_name

Stem Cells Transl Med

authors

Devito L,Petrova A,Miere C,Codognotto S,Blakely N,Lovatt A,Ogilvie C,Khalaf Y,Ilic D

doi

10.5966/sctm.2014-0015

subject

Has Abstract

pub_date

2014-10-01 00:00:00

pages

1116-24

issue

10

eissn

2157-6564

issn

2157-6580

pii

sctm.2014-0015

journal_volume

3

pub_type

杂志文章
  • Multipotent mesenchymal stromal cells synergize with costimulation blockade in the inhibition of immune responses and the induction of Foxp3+ regulatory T cells.

    abstract::Multipotent mesenchymal stromal cell (MSC) therapy and costimulation blockade are two immunomodulatory strategies being developed concomitantly for the treatment of immunological diseases. Both of these strategies have the capacity to inhibit immune responses and induce regulatory T cells; however, their ability to sy...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2014-0012

    authors: Takahashi T,Tibell A,Ljung K,Saito Y,Gronlund A,Osterholm C,Holgersson J,Lundgren T,Ericzon BG,Corbascio M,Kumagai-Braesch M

    更新日期:2014-12-01 00:00:00

  • Functional and Transcriptional Characterization of Histone Deacetylase Inhibitor-Mediated Cardiac Adverse Effects in Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes.

    abstract:UNLABELLED:Histone deacetylase (HDAC) inhibitors possess therapeutic potential to reverse aberrant epigenetic changes associated with cancers, neurological diseases, and immune disorders. Unfortunately, clinical studies with some HDAC inhibitors displayed delayed cardiac adverse effects, such as atrial fibrillation and...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2015-0279

    authors: Kopljar I,Gallacher DJ,De Bondt A,Cougnaud L,Vlaminckx E,Van den Wyngaert I,Lu HR

    更新日期:2016-05-01 00:00:00

  • Hierarchy of breast cancer cells: key to reverse dormancy for therapeutic intervention.

    abstract::An understanding of how cancer cells adapt dormancy would allow for targeted treatment. The current literature suggests that the cancer stem cells might be the major cells with the ability to become quiescent and to resist current drug treatment. The properties of cancer stem cells and healthy stem cells are functiona...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章,评审

    doi:10.5966/sctm.2014-0013

    authors: Bliss SA,Greco SJ,Rameshwar P

    更新日期:2014-07-01 00:00:00

  • Comparative Analysis of Media and Supplements on Initiation and Expansion of Adipose-Derived Stem Cells.

    abstract::Adipose-derived stem cells (ASCs) are being tested in clinical trials related to cell-based regenerative therapies. Although most of the current expansion protocols for ASCs use fetal calf serum (FCS), xenogeneic-free medium supplements are greatly desired. This study aims to compare the effect of FCS, human platelet ...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2015-0148

    authors: Riis S,Nielsen FM,Pennisi CP,Zachar V,Fink T

    更新日期:2016-03-01 00:00:00

  • Efficient lentiviral transduction of human mesenchymal stem cells that preserves proliferation and differentiation capabilities.

    abstract::Long-term lentiviral transduction of human mesenchymal stem cells (hMSCs) greatly enhances the usefulness of these cells. However, such transduction currently requires the use of polybrene, which severely inhibits hMSC proliferation. In contrast, protamine sulfate at 100 μg/ml doubled transduction efficiencies without...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2012-0086

    authors: Lin P,Lin Y,Lennon DP,Correa D,Schluchter M,Caplan AI

    更新日期:2012-12-01 00:00:00

  • Concise Review: Is Cardiac Cell Therapy Dead? Embarrassing Trial Outcomes and New Directions for the Future.

    abstract::Stem cell therapy is a promising strategy for tissue regeneration. The therapeutic benefits of cell therapy are mediated by both direct and indirect mechanisms. However, the application of stem cell therapy in the clinic is hampered by several limitations. This concise review provides a brief introduction into stem ce...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章,评审

    doi:10.1002/sctm.17-0196

    authors: Tang JN,Cores J,Huang K,Cui XL,Luo L,Zhang JY,Li TS,Qian L,Cheng K

    更新日期:2018-04-01 00:00:00

  • Alteration of naïve and memory B-cell subset in chronic graft-versus-host disease patients after treatment with mesenchymal stromal cells.

    abstract::Although mesenchymal stromal cells (MSCs) possess immunomodulatory properties and exhibit promising efficacy against chronic graft-versus-host disease (cGVHD), little is known about the immune changes by which MSCs ameliorate cGVHD in vivo. Recent studies have suggested that B lymphocytes might play an important role ...

    journal_title:Stem cells translational medicine

    pub_type: 临床试验,杂志文章

    doi:10.5966/sctm.2014-0001

    authors: Peng Y,Chen X,Liu Q,Xu D,Zheng H,Liu L,Liu Q,Liu M,Fan Z,Sun J,Li X,Zou R,Xiang AP

    更新日期:2014-09-01 00:00:00

  • Lung Injury Repair by Transplantation of Adult Lung Cells Following Preconditioning of Recipient Mice.

    abstract::Repair of injured lungs represents a longstanding therapeutic challenge. We recently demonstrated that human and mouse embryonic lung tissue from the canalicular stage of development are enriched with lung progenitors, and that a single cell suspension of canalicular lungs can be used for transplantation, provided tha...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.17-0149

    authors: Milman Krentsis I,Rosen C,Shezen E,Aronovich A,Nathanson B,Bachar-Lustig E,Berkman N,Assayag M,Shakhar G,Feferman T,Orgad R,Reisner Y

    更新日期:2018-01-01 00:00:00

  • Functional Maturation of Induced Pluripotent Stem Cell Hepatocytes in Extracellular Matrix-A Comparative Analysis of Bioartificial Liver Microenvironments.

    abstract:UNLABELLED:: Induced pluripotent stem cells (iPSCs) are new diagnostic and potentially therapeutic tools to model disease and assess the toxicity of pharmaceutical medications. A common limitation of cell lineages derived from iPSCs is a blunted phenotype compared with fully developed, endogenous cells. We examined the...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2015-0235

    authors: Wang B,Jakus AE,Baptista PM,Soker S,Soto-Gutierrez A,Abecassis MM,Shah RN,Wertheim JA

    更新日期:2016-09-01 00:00:00

  • Concise review: cell therapy and tissue engineering for cardiovascular disease.

    abstract::Cardiovascular disease is a major cause of morbidity and mortality, especially in developed countries. Various therapies for cardiovascular disease are investigated actively and are performed clinically. Recently, cell-based regenerative medicine using several cell sources has appeared as an alternative therapy for cu...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章,评审

    doi:10.5966/sctm.2012-0030

    authors: Haraguchi Y,Shimizu T,Yamato M,Okano T

    更新日期:2012-02-01 00:00:00

  • Cell Mass Increase Associated with Formation of Glucose-Controlling β-Cell Mass in Device-Encapsulated Implants of hiPS-Derived Pancreatic Endoderm.

    abstract::Device-encapsulated human stem cell-derived pancreatic endoderm (PE) can generate functional β-cell implants in the subcutis of mice, which has led to the start of clinical studies in type 1 diabetes. Assessment of the formed functional β-cell mass (FBM) and its correlation with in vivo metabolic markers can guide cli...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.19-0043

    authors: Robert T,De Mesmaeker I,Van Hulle FO,Suenens KG,Stangé GM,Ling Z,Haller C,Bouche N,Keymeulen B,Kraus MRC,Pipeleers DG

    更新日期:2019-12-01 00:00:00

  • Cryopreserved Off-the-Shelf Allogeneic Adipose-Derived Stromal Cells for Therapy in Patients with Ischemic Heart Disease and Heart Failure-A Safety Study.

    abstract::The present first-in-human clinical trial evaluated the safety and feasibility of a newly developed and cryopreserved Cardiology Stem Cell Centre adipose-derived stromal cell (CSCC_ASC) product from healthy donors for intramyocardial injection in ten patients with ischemic heart disease and ischemic heart failure (IHF...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.17-0040

    authors: Kastrup J,Haack-Sørensen M,Juhl M,Harary Søndergaard R,Follin B,Drozd Lund L,Mønsted Johansen E,Ali Qayyum A,Bruun Mathiasen A,Jørgensen E,Helqvist S,Jørgen Elberg J,Bruunsgaard H,Ekblond A

    更新日期:2017-11-01 00:00:00

  • Generation of a Bone Organ by Human Adipose-Derived Stromal Cells Through Endochondral Ossification.

    abstract:UNLABELLED:: Recapitulation of endochondral ossification (ECO) (i.e., generation of marrow-containing ossicles through a cartilage intermediate) has relevance to develop human organotypic models for bone or hematopoietic cells and to engineer grafts for bone regeneration. Unlike bone marrow-derived stromal cells (also ...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2015-0256

    authors: Osinga R,Di Maggio N,Todorov A,Allafi N,Barbero A,Laurent F,Schaefer DJ,Martin I,Scherberich A

    更新日期:2016-08-01 00:00:00

  • Sustained release of bone morphogenetic protein 2 via coacervate improves the osteogenic potential of muscle-derived stem cells.

    abstract::Muscle-derived stem cells (MDSCs) isolated from mouse skeletal muscle by a modified preplate technique exhibit long-term proliferation, high self-renewal, and multipotent differentiation capabilities in vitro. MDSCs retrovirally transduced to express bone morphogenetic proteins (BMPs) can differentiate into osteocytes...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2013-0027

    authors: Li H,Johnson NR,Usas A,Lu A,Poddar M,Wang Y,Huard J

    更新日期:2013-09-01 00:00:00

  • Cross talk between mesenchymal and glioblastoma stem cells: Communication beyond controversies.

    abstract::Mesenchymal stem cells (MSCs) can be isolated from bone marrow or other adult tissues (adipose tissue, dental pulp, amniotic fluid, and umbilical cord). In vitro, MSCs grow as adherent cells, display fibroblast-like morphology, and self-renew, undergoing specific mesodermal differentiation. High heterogeneity of MSCs ...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章,评审

    doi:10.1002/sctm.20-0161

    authors: Bajetto A,Thellung S,Dellacasagrande I,Pagano A,Barbieri F,Florio T

    更新日期:2020-11-01 00:00:00

  • Oral Mucosal Lamina Propria-Progenitor Cells Exert Antibacterial Properties via the Secretion of Osteoprotegerin and Haptoglobin.

    abstract:UNLABELLED:The oral cavity possesses a diverse microflora, yet recurrent infections within healthy individuals are rare. Wound healing within the buccal mucosa is preferential, potentially because of the presence of oral mucosal lamina propria-progenitor cells (OMLP-PCs). In addition to their multipotency, OMLP-PCs dem...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2015-0043

    authors: Board-Davies E,Moses R,Sloan A,Stephens P,Davies LC

    更新日期:2015-11-01 00:00:00

  • Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial.

    abstract::Knee osteoarthritis (OA) is a leading cause of pain and disability. Although conventional treatments show modest benefits, pilot and phase I/II trials with bone marrow (BM) and adipose-derived (AD) mesenchymal stromal cells (MSCs) point to the feasibility, safety, and occurrence of clinical and structural improvement ...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/sctm.18-0053

    authors: Matas J,Orrego M,Amenabar D,Infante C,Tapia-Limonchi R,Cadiz MI,Alcayaga-Miranda F,González PL,Muse E,Khoury M,Figueroa FE,Espinoza F

    更新日期:2019-03-01 00:00:00

  • Bystander Effect Fuels Human Induced Pluripotent Stem Cell-Derived Neural Stem Cells to Quickly Attenuate Early Stage Neurological Deficits After Stroke.

    abstract:UNLABELLED:: Present therapies for stroke rest with tissue plasminogen activator (tPA), the sole licensed antithrombotic on the market; however, tPA's effectiveness is limited in that the drug not only must be administered less than 3-5 hours after stroke but often exacerbates blood-brain barrier (BBB) leakage and incr...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2014-0184

    authors: Eckert A,Huang L,Gonzalez R,Kim HS,Hamblin MH,Lee JP

    更新日期:2015-07-01 00:00:00

  • Distinct mobilization of circulating CD271+ mesenchymal progenitors from hematopoietic progenitors during aging and after myocardial infarction.

    abstract::The specific cell surface markers on mesenchymal stem/progenitor cells (MSCs) have been poorly defined in vivo, but in one recent study, an MSC subpopulation was directly isolated from a CD271-positive fraction of human bone marrow cells. The aim of this study was to identify circulating CD271(+) MSCs in human periphe...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2011-0051

    authors: Iso Y,Yamaya S,Sato T,Poole CN,Isoyama K,Mimura M,Koba S,Kobayashi Y,Takeyama Y,Spees JL,Suzuki H

    更新日期:2012-06-01 00:00:00

  • Enhancement of polysialic acid expression improves function of embryonic stem-derived dopamine neuron grafts in Parkinsonian mice.

    abstract::There has been considerable progress in obtaining engraftable embryonic stem (ES) cell-derived midbrain dopamine neurons for cell replacement therapy in models of Parkinson's disease; however, limited integration and striatal reinnervation of ES-derived grafts remain a major challenge for future clinical translation. ...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2013-0084

    authors: Battista D,Ganat Y,El Maarouf A,Studer L,Rutishauser U

    更新日期:2014-01-01 00:00:00

  • Mesenchymal Stromal Cell-Seeded Biomimetic Scaffolds as a Factory of Soluble RANKL in Rankl-Deficient Osteopetrosis.

    abstract::Biomimetic scaffolds are extremely versatile in terms of chemical composition and physical properties, which can be defined to accomplish specific applications. One property that can be added is the production/release of bioactive soluble factors, either directly from the biomaterial, or from cells embedded within the...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.18-0085

    authors: Menale C,Campodoni E,Palagano E,Mantero S,Erreni M,Inforzato A,Fontana E,Schena F,Van't Hof R,Sandri M,Tampieri A,Villa A,Sobacchi C

    更新日期:2019-01-01 00:00:00

  • Multicolor staining of globin subtypes reveals impaired globin switching during erythropoiesis in human pluripotent stem cells.

    abstract::Adult hemoglobin composed of α- and β-globin reflects a change from expression of embryonic ε- and fetal γ-globin to adult β-globin in human erythroid cells, so-called globin switching. Human pluripotent stem cells (hPSCs) are a potential source for in vitro erythrocyte production, but they show prominent expression o...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2013-0216

    authors: Ochi K,Takayama N,Hirose S,Nakahata T,Nakauchi H,Eto K

    更新日期:2014-07-01 00:00:00

  • Dynamic Changes in Brain Mesenchymal Perivascular Cells Associate with Multiple Sclerosis Disease Duration, Active Inflammation, and Demyelination.

    abstract::Vascular changes, including blood brain barrier destabilization, are common pathological features in multiple sclerosis (MS) lesions. Blood vessels within adult organs are reported to harbor mesenchymal stromal cells (MSCs) with phenotypical and functional characteristics similar to pericytes. We performed an immunohi...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.17-0028

    authors: Iacobaeus E,Sugars RV,Törnqvist Andrén A,Alm JJ,Qian H,Frantzen J,Newcombe J,Alkass K,Druid H,Bottai M,Röyttä M,Le Blanc K

    更新日期:2017-10-01 00:00:00

  • A Phase I Study to Assess the Safety and Cancer-Homing Ability of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells in Men with Localized Prostate Cancer.

    abstract::Animal models show that systemically administered bone marrow-derived mesenchymal stem cells (MSCs) home to sites of primary and metastatic prostate cancer (PC)-making them candidates to selectively deliver cytotoxic agents. To further assess this potential as a cell-based therapeutic vehicle, a phase I study testing ...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.18-0230

    authors: Schweizer MT,Wang H,Bivalacqua TJ,Partin AW,Lim SJ,Chapman C,Abdallah R,Levy O,Bhowmick NA,Karp JM,De Marzo A,Isaacs JT,Brennen WN,Denmeade SR

    更新日期:2019-05-01 00:00:00

  • A robust culture system to generate neural progenitors with gliogenic competence from clinically relevant induced pluripotent stem cells for treatment of spinal cord injury.

    abstract::Cell-based therapy targeting spinal cord injury (SCI) is an attractive approach to promote functional recovery by replacing damaged tissue. We and other groups have reported the effectiveness of transplanting neural stem/progenitor cells (NS/PCs) derived from human induced pluripotent stem cells (hiPSCs) in SCI animal...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.1002/sctm.20-0269

    authors: Kamata Y,Isoda M,Sanosaka T,Shibata R,Ito S,Okubo T,Shinozaki M,Inoue M,Koya I,Shibata S,Shindo T,Matsumoto M,Nakamura M,Okano H,Nagoshi N,Kohyama J

    更新日期:2020-11-23 00:00:00

  • The Infrapatellar Fat Pad as a Source of Perivascular Stem Cells with Increased Chondrogenic Potential for Regenerative Medicine.

    abstract::Perivascular stem cells (PSCs) are the natural ancestors of mesenchymal stem cells (MSCs) and are the stem cells responsible for homeostasis and repair in vivo. Prospectively identified and isolated PSCs have demonstrated increased plasticity and osteogenic potential. Cells from the infrapatellar fat pad (IFP) have de...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2016-0040

    authors: Hindle P,Khan N,Biant L,Péault B

    更新日期:2017-01-01 00:00:00

  • Concise review: next-generation cell therapies to prevent infections in neutropenic patients.

    abstract::High-dose chemotherapy is accompanied by an obligate period of neutropenia. Resulting bacterial and fungal infections are the leading cause of morbidity and mortality in neutropenic patients despite prophylactic antimicrobials and hematopoietic growth factor supplements. Replacing neutrophils in the patient through tr...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章,评审

    doi:10.5966/sctm.2013-0145

    authors: Brunck ME,Nielsen LK

    更新日期:2014-04-01 00:00:00

  • Anti-inflammatory mesenchymal stem cells (MSC2) attenuate symptoms of painful diabetic peripheral neuropathy.

    abstract::Mesenchymal stem cells (MSCs) are very attractive candidates in cell-based strategies that target inflammatory diseases. Preclinical animal studies and many clinical trials have demonstrated that human MSCs can be safely administered and that they modify the inflammatory process in the targeted injured tissue. Our lab...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2012-0025

    authors: Waterman RS,Morgenweck J,Nossaman BD,Scandurro AE,Scandurro SA,Betancourt AM

    更新日期:2012-07-01 00:00:00

  • Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent.

    abstract::Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for rese...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2012-0029

    authors: Lowenthal J,Lipnick S,Rao M,Hull SC

    更新日期:2012-05-01 00:00:00

  • Enhanced Immunosuppression of T Cells by Sustained Presentation of Bioactive Interferon-γ Within Three-Dimensional Mesenchymal Stem Cell Constructs.

    abstract::The immunomodulatory activity of mesenchymal stem/stromal cells (MSCs) to suppress innate and adaptive immune responses offers a potent cell therapy for modulating inflammation and promoting tissue regeneration. However, the inflammatory cytokine milieu plays a critical role in stimulating MSC immunomodulatory activit...

    journal_title:Stem cells translational medicine

    pub_type: 杂志文章

    doi:10.5966/sctm.2016-0044

    authors: Zimmermann JA,Hettiaratchi MH,McDevitt TC

    更新日期:2017-01-01 00:00:00