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1.
Stem Cells Transl Med ; 9(5): 547-553, 2020 May.
Article in English | MEDLINE | ID: mdl-32040254

ABSTRACT

The promise of cell and gene therapies is being realized as new products emerge to treat diseases once considered intractable. These treatments are emerging amidst reports of patients being injured by unproven "stem cell" interventions. At this juncture, it is vital to be supporting the continued development of promising regenerative medicine products while protecting patients from the risks posed by unproven interventions. Various stakeholders, including governments, patient groups, medical societies, and the media, are committed to this outcome. In this perspective, we draw on our experience gained from partnerships in developing regenerative medicine products to identify technical, organizational, and ethical benchmarks for the responsible delivery of regenerative medicine treatments. These benchmarks may serve as the basis for policy interventions intended to drive the responsible delivery of stem cell and regenerative medicine products. Our particular focus is on a California-based policy, but the suggested benchmarks are broadly applicable to national and international jurisdictions.


Subject(s)
Stem Cell Transplantation/methods , Humans
2.
Stem Cell Reports ; 10(1): 1-6, 2018 01 09.
Article in English | MEDLINE | ID: mdl-29320760

ABSTRACT

Unambiguous cell line authentication is essential to avoid loss of association between data and cells. The risk for loss of references increases with the rapidity that new human pluripotent stem cell (hPSC) lines are generated, exchanged, and implemented. Ideally, a single name should be used as a generally applied reference for each cell line to access and unify cell-related information across publications, cell banks, cell registries, and databases and to ensure scientific reproducibility. We discuss the needs and requirements for such a unique identifier and implement a standard nomenclature for hPSCs, which can be automatically generated and registered by the human pluripotent stem cell registry (hPSCreg). To avoid ambiguities in PSC-line referencing, we strongly urge publishers to demand registration and use of the standard name when publishing research based on hPSC lines.


Subject(s)
Biological Specimen Banks , Databases, Factual , Pluripotent Stem Cells , Registries , Terminology as Topic , Humans
3.
Stem Cells Transl Med ; 7(1): 6-10, 2018 01.
Article in English | MEDLINE | ID: mdl-29105375

ABSTRACT

The California Institute for Regenerative Medicine has formed a group of clinics called the Alpha Stem Cell Clinics Network. Its goal is to accelerate clinical trials of stem cell-based therapies for diseases with unmet medical needs. In this report, we describe our experience in establishing an Alpha Stem Cell Clinic at City of Hope. Implementation and integration of the clinic into the existing institutional structures required collaboration and cooperation with clinical trial units, nursing administration, and creation of new positions. The highlight of this process and the centerpiece to our success has been the definition of the role of the "hybrid nurse," a person with nursing competencies in both clinical care and research. Stem Cells Translational Medicine 2018;7:6-10 Abstract Video Link: https://youtu.be/WOeZrNyXkGU.


Subject(s)
Cell- and Tissue-Based Therapy/methods , Nursing/methods , Regenerative Medicine/methods , Stem Cell Research , Education, Nursing , Humans , Stem Cell Transplantation
4.
Stem Cells Transl Med ; 4(2): 123-9, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25561681

ABSTRACT

Human somatic cell reprogramming is a leading technology for accelerating disease modeling and drug discovery. The Deriving Induced Stem Cells Using Stored Specimens (DISCUSS) project is a consensus-building initiative designed to consider how human somatic cells obtained under general biomedical research protocols can be used in induced pluripotent stem cell (iPSC) derivation. We previously published a draft list of points to consider for the use of previously collected specimens in iPSC research and then initiated a structured feedback and comment process. Here, we present a summary of this feedback and revised list of points to consider.


Subject(s)
Drug Discovery , Induced Pluripotent Stem Cells , Specimen Handling , Cell Line , Humans , Stem Cell Research
6.
Stem Cells Transl Med ; 3(9): 979-91, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25150264

ABSTRACT

In March 2013, the California Institute for Regenerative Medicine, in collaboration with the NIH Center for Regenerative Medicine, held a 2-day workshop on cell therapies for Parkinson's disease (PD), with the goals of reviewing the state of stem cell research for the treatment of PD and discussing and refining the approach and the appropriate patient populations in which to plan and conduct new clinical trials using stem cell-based therapies for PD. Workshop participants identified priorities for research, development, and funding; discussed existing resources and initiatives; and outlined a path to the clinic for a stem cell-based therapy for PD. A consensus emerged among participants that the development of cell replacement therapies for PD using stem cell-derived products could potentially offer substantial benefits to patients. As with all stem cell-based therapeutic approaches, however, there are many issues yet to be resolved regarding the safety, efficacy, and methodology of transplanting cell therapies into patients. Workshop participants agreed that designing an effective stem cell-based therapy for PD will require further research and development in several key areas. This paper summarizes the meeting.


Subject(s)
Cell- and Tissue-Based Therapy/trends , Parkinson Disease/therapy , Animals , Cell- and Tissue-Based Therapy/methods , Humans
8.
Cell Stem Cell ; 14(4): 427-30, 2014 Apr 03.
Article in English | MEDLINE | ID: mdl-24702994

ABSTRACT

Data sharing is an essential element of research; however, recent scientific and social developments have challenged conventional methods for protecting privacy. Here we provide guidance for determining data sharing thresholds for human pluripotent stem cell research aimed at a wide range of stakeholders, including research consortia, biorepositories, policy-makers, and funders.


Subject(s)
Pluripotent Stem Cells/cytology , Privacy , Stem Cell Research/ethics , Humans , Stem Cell Research/legislation & jurisprudence
9.
Stem Cells Dev ; 22 Suppl 1: 25-8, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24304071

ABSTRACT

In May, Oregon Health and Science University (OHSU) announced the successful derivation, by the Mitalipov laboratory, of embryonic stem cells by somatic cell nuclear transfer. This experiment was recognized as a "formidable technical feat" and potentially a key step toward developing cell-based therapies. The OHSU report is also an example of how a scientific breakthrough can inform research ethics. This article suggests ways that nuclear transfer embryonic stem cell lines may contribute to research ethics by adding rigor to studies addressing pressing research questions important to the development of cell-based therapies.


Subject(s)
Cell- and Tissue-Based Therapy/trends , Embryonic Stem Cells , Induced Pluripotent Stem Cells , Cell Differentiation/genetics , Humans , Nuclear Transfer Techniques , Oregon
10.
Stem Cells Transl Med ; 2(10): 727-30, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23990574

ABSTRACT

Human somatic cell reprogramming is a leading technology for accelerating disease modeling and drug discovery. Research organizations are sponsoring initiatives to create libraries of induced pluripotent stem cell (iPSC) lines for broad distribution and application. Donor informed consent plays a critical role in supporting the ethical conduct of iPSC research. To date, our organizations have focused on informed consent considerations for somatic cell collection intended specifically for iPSC derivation and distribution. This article considers how somatic cells obtained under general (biomedical) research protocols can be used for iPSC derivation. We present draft Points to Consider regarding the use of human somatic cells for iPSC research. Our goal is to initiate a process designed to develop consensus for the use of previously collected specimens for iPSC research. We anticipate publishing final considerations in early 2014.


Subject(s)
Biological Specimen Banks/ethics , Induced Pluripotent Stem Cells , Informed Consent , Cell Line , Humans
12.
13.
Stem Cell Res Ther ; 4(1): 6, 2013 Jan 21.
Article in English | MEDLINE | ID: mdl-23336317

ABSTRACT

Efforts have emerged internationally to recruit donors with specific disease indications and to derive induced pluripotent cell lines. These disease-specific induced pluripotent stem cell lines have the potential to accelerate translational goals such as drug discovery and testing. One consideration for donor recruitment and informed consent is the possibility that research will result in findings that are clinically relevant to the cell donor. Management protocols for such findings should be developed a priori and disclosed during the informed consent process. The California Institute for Regenerative Medicine has developed recommendations for informing donors in sponsored research. These recommendations include obtaining consent to recontact tissue donors for a range of scientific, medical and ethical considerations. This article reviews the basis for these recommendations and suggests conditions that may be appropriate when reporting findings to donors.


Subject(s)
Induced Pluripotent Stem Cells/physiology , Informed Consent , Mental Competency , Cell Line , Humans , Tissue Donors , Translational Research, Biomedical/methods
15.
Regen Med ; 7(3): 439-48, 2012 May.
Article in English | MEDLINE | ID: mdl-22594334

ABSTRACT

Prompted by an increased interest of both research participants and the patient advocacy community in obtaining information about research outcomes and on the use of their biological samples; the international community has begun to debate the emergence of an ethical 'duty' to return research results to participants. Furthermore, the use of new technologies (e.g., whole-genome and -exome sequencing) has revealed both genetic data and incidental findings with possible clinical significance. These technologies together with the proliferation of biorepositories, provide a compelling rationale for governments and scientific institutions to adopt prospective policies. Given the scarcity of policies in the context of stem cell research, a discussion on the scientific, ethical and legal implications of disclosing research results for research participants is needed. We present the International Stem Forum Ethics Working Party's Policy Statement and trust that it will stimulate debate and meet the concerns of researchers and research participants alike.


Subject(s)
Disclosure/ethics , Policy , Stem Cell Research/ethics , Tissue Banks/ethics , Health Planning Guidelines , Humans
16.
Stem Cell Rev Rep ; 8(2): 299-304, 2012 Jun.
Article in English | MEDLINE | ID: mdl-21837381

ABSTRACT

The term "stem cell exceptionalism" has been used to characterize the policy response to controversies surrounding human embryonic stem cell research. For example, governments and funding agencies have adopted policies governing the derivation and use of human embryonic stem cell lines. These policies have effectively served to fill gaps in existing guidelines and regulations and signal that scientists are committed to a responsible framework for the conduct of research involving human embryos. Recent publications discuss whether ethical and policy issues associated with induced pluripotent cells (iPSCs) from non-embryonic sources create a need for further policy intervention. We suggest many of the issues identified by commentators may be addressed through the application of established policy frameworks governing the use of tissue, human stem cells, and research participation by human research subjects. To the extent, iPSC research intersects with hESC research (e.g. the creation of human gametes and/or embryos), the policy framework governing hESC appears sufficiently robust at this time.


Subject(s)
Policy , Stem Cells/cytology , Confidentiality , Humans , Informed Consent , Tissue Donors , Translational Research, Biomedical
17.
Regen Med ; 6(6): 783-92, 2011 Nov.
Article in English | MEDLINE | ID: mdl-22050529

ABSTRACT

Stem cell repositories, similar to many areas in human scientific research, must balance the interests of the individuals who donate their time and samples to science with the interests of scientific progress. This article seeks to explore how sustained interaction with stem cell donors can advance key donor interests (autonomy and privacy) while also increasing the scientific utility of stem cell lines. The ability to trace stem cell lines to their respective donors - underpinned by robust informed consent - enables donors to gain access to information regarding research outcomes and the uses of their biological samples, while also supporting basic and clinical research by providing a means for quality and safety controls. Measures to recontact donors and also to enable donors to withdraw from research should be well designed to ensure donors' preferences are respected while mitigating negative consequences resulting from limited data availability or compromised sample quality. To guarantee the integrity of research while respecting donors' autonomy and preferences, stem cell repositories require a prospective approach to informed consent.


Subject(s)
Cooperative Behavior , Stem Cells/cytology , Tissue Banks , Anonyms and Pseudonyms , Humans , Tissue Donors
18.
Regen Med ; 6(6 Suppl): 121-4, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21999274

ABSTRACT

Research suggests that the representation of scientific and medical issues in the traditional media such as newspapers, TV and radio is an important determinant of public opinion and related public policy outcomes, particularly with regard to attitudes toward stem cell research. With the emergence of social media, the discursive space around public policy issues has expanded to include a new demographic of media consumer who is directly involved in political action. However, little is known about the influence of social media on scientific public policy conversations. We analyzed Twitter posts on two topics relating to stem cell science and policy according to the originator and tone of the tweet, and whether the tweet was intended to be neutral or to further a stated policy position. This analysis provides a means for clarifying the role of social media in influencing public opinion of policy issues such as stem cell research and offers organizations a better understanding of how to more effectively apply social media to advancing their stem cell policy positions.


Subject(s)
Science , Social Media , Stem Cell Research , Access to Information , Attitude , Attitude to Health , Data Collection/statistics & numerical data , Dissent and Disputes , Humans , Mass Media , Public Opinion , Public Policy , Regenerative Medicine/legislation & jurisprudence , Science/ethics , Science/legislation & jurisprudence , Science/methods , Social Media/organization & administration , Social Media/statistics & numerical data , Stem Cell Research/legislation & jurisprudence , Surveys and Questionnaires , Trachea/transplantation
19.
Cell Stem Cell ; 8(4): 357-9, 2011 Apr 08.
Article in English | MEDLINE | ID: mdl-21474098

ABSTRACT

Human embryonic and induced pluripotent stem cell lines are being generated at a rapid pace and now number in the thousands. We propose a standard nomenclature and suggest the use of a centralized database for all cell line names and a minimum set of information for reporting new derivations.


Subject(s)
Embryonic Stem Cells/cytology , Induced Pluripotent Stem Cells/cytology , Terminology as Topic , Cell Line , Humans , Reference Standards
20.
Stem Cell Rev Rep ; 7(3): 482-4, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21279481

ABSTRACT

Novel methods and associated tools permitting individual identification in publicly accessible SNP databases have become a debatable issue. There is growing concern that current technical and ethical safeguards to protect the identities of donors could be insufficient. In the context of human embryonic stem cell research, there are no studies focusing on the probability that an hESC line donor could be identified by analyzing published SNP profiles and associated genotypic and phenotypic information. We present the International Stem Cell Forum (ISCF) Ethics Working Party's Policy Statement on "Publishing SNP Genotypes of Human Embryonic Stem Cell Lines (hESC)". The Statement prospectively addresses issues surrounding the publication of genotypic data and associated annotations of hESC lines in open access databases. It proposes a balanced approach between the goals of open science and data sharing with the respect for fundamental bioethical principles (autonomy, privacy, beneficence, justice and research merit and integrity).


Subject(s)
Cell Line , Embryonic Stem Cells/physiology , Genotype , Policy , Polymorphism, Single Nucleotide , Stem Cell Research , Humans , International Cooperation , Stem Cell Research/ethics , Stem Cell Research/legislation & jurisprudence
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