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'. Through an analysis of comments submitted to the US FDA in 2016 in response to recent draft guidance documents, I show that a sense of ownership and identity in autologous cells is consistently expressed by stakeholders. In the USA and other countries, regulation of cell and tissue biologics as 'drugs' relies substantially on whether a given product has been modified in ways that alter its biological properties, which has direct implications for property and ownership rights. Competing views on property rights in 'natural' and modified autologous cells have profound implications for the future of regulation of marketed autologous cells.
journal_name
Regen Medjournal_title
Regenerative medicineauthors
Sipp Ddoi
10.2217/rme-2017-0063subject
Has Abstractpub_date
2017-10-01 00:00:00pages
827-838issue
7eissn
1746-0751issn
1746-076Xjournal_volume
12pub_type
杂志文章abstract::Tissue engineering is a field of study unto itself, but in reality, it is a fusion of medicine, pharmacology, chemistry, cell biology, molecular biology and engineering. The field has been developing at an ever-increasing pace and already provides benefits to regenerative medicine in areas such as the skin and cornea....
journal_title:Regenerative medicine
pub_type: 杂志文章,评审
doi:10.2217/rme.13.16
更新日期:2013-05-01 00:00:00
abstract:AIM:To perform an early cost-effectiveness analysis of in vitro expanded myoblasts (IVM) and minced myofibers versus midurethral slings (MUS) for surgical treatment of female stress urinary incontinence. METHODS:Cost-effectiveness and sensitivity analyses were performed using a decision tree comprising previously publ...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme-2017-0124
更新日期:2018-04-01 00:00:00
abstract::Aim: The most common risk associated with intradiscal injection of platelet-rich plasma (PRP) is discitis with Cutibacterium acnes. It is hypothesized that antimicrobial activity of PRP can be enhanced through inclusion of leukocytes or antibiotics in the injectate. Materials & methods: Multiple PRP preparations of va...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme-2019-0098
更新日期:2019-10-01 00:00:00
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
更新日期:2013-11-01 00:00:00
abstract:AIM:Evaluation of survival, proliferation and neurodifferentiation of dental stem cells from the apical papilla (SCAP) in fibrin hydrogels. We hypothesized that fibrin composition will influence cell behavior. METHODS:Modulus, pore and fiber size were measured. SCAP in vitro viability, proliferation and neural differe...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme.14.81
更新日期:2015-01-01 00:00:00
abstract:AIM:Secondary lymphedema is observed in common after postmalignancy treatment of the breast and the gynecologic organs but effective therapies are not established. Adipose-derived stem cells (ADSCs), which are pluripotent, regenerative in local injection, are tested for murine hindlimb secondary lymphedema by regenerat...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme.15.24
更新日期:2015-01-01 00:00:00
abstract::Tendons and ligaments are related connective tissues that join muscle to bone and bone to bone, respectively. Tendon and ligament injuries are widely distributed clinical problems in society and while healing of such disorders can occur, the original biological properties of the tissue do not return to normal. In this...
journal_title:Regenerative medicine
pub_type: 杂志文章,评审
doi:10.2217/17460751.1.4.563
更新日期:2006-07-01 00:00:00
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
更新日期:2012-11-01 00:00:00
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
更新日期:2007-11-01 00:00:00
abstract::Osteoarthritis is a common disorder in which there is not only extensive degeneration but also an aberrant attempt at repair in joints. Stem cell therapy could provide a permanent, biological solution, with all sources of stem cells (embryonic, fetal and adult) showing some degree of potential. Mesenchymal stromal/ste...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme.11.21
更新日期:2011-05-01 00:00:00
abstract::Aim: A limiting factor in advancement of bone marrow based cell therapies is the lack of characterization of cell products delivered to patients. Methods: Using an automated hematology analyzer that can be implemented in clinical setting, the composition of bone marrow aspirates (n = 17 patients) and bone marrow conce...
journal_title:Regenerative medicine
pub_type: 临床试验,杂志文章
doi:10.2217/rme-2018-0173
更新日期:2019-07-01 00:00:00
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
更新日期:2010-07-01 00:00:00
abstract:AIM:Placental allografts used for tissue regeneration differ in membrane compositions and processing techniques. A uniquely folded dehydrated binate amniotic membrane (DBAM) was biochemically characterized to evaluate its potential role in wound healing. METHODS:Histology, Luminex-based immunoassay and standard in vit...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme-2018-0085
更新日期:2018-09-01 00:00:00
abstract::The determinants of adoption of regenerative medicine therapies are currently poorly understood. This study aims to draw comparison between the UK and Canada in terms of factors likely to affect healthcare adoption of future regenerative therapies in ophthalmology. Conducting semi-structured interviews with senior oph...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme.14.82
更新日期:2015-05-01 00:00:00
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
更新日期:2011-01-01 00:00:00
abstract::Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities. This requires agreement on the critical quality attributes of such l...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme-2018-0095
更新日期:2018-10-01 00:00:00
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
更新日期:2015-01-01 00:00:00
abstract::In June 2013, the US Supreme Court ruled that naturally occurring genes were unpatentable in the case Association for Molecular Pathology v. Myriad Genetics. Up until this decision, Myriad Genetics was the only company in the USA that could legally conduct diagnostic testing for BRCA1 and 2, genes that are linked to f...
journal_title:Regenerative medicine
pub_type: 杂志文章,评审
doi:10.2217/rme.13.93
更新日期:2014-03-01 00:00:00
abstract:AIM:Dendritic cell (DC)-based vaccines have a potential utility for use in the treatment of malignancy. Human embryonic stem cells (hESCs) may provide a more cost-effective and reliable source of DCs for immunotherapy purposes, providing on-demand access for patients. METHOD:We developed a protocol to generate DCs fro...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme.09.25
更新日期:2009-07-01 00:00:00
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
更新日期:2020-10-01 00:00:00
abstract::Worldwide, tissue engineering and cellular replacement therapies are at the forefront of the regenerative medicine agenda, and researchers are addressing key diseases, including diabetes, stroke and neurological disorders. It is becoming evident that neurological cell therapy is a necessarily complex endeavor. The bra...
journal_title:Regenerative medicine
pub_type: 杂志文章,评审
doi:10.2217/rme.12.2
更新日期:2012-05-01 00:00:00
abstract::Background: To evaluate whether subtenon injection of platelet-rich plasma (PRP) with retinal electromagnetic stimulation (rEMS) is effective in therapy-resistant chronic central serous chorioretinopathy (CSCR). Design: Prospective, sequential. Materials & methods: The study included 22 eyes with resistant chronic CSC...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme-2020-0056
更新日期:2020-08-01 00:00:00
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
更新日期:2020-06-01 00:00:00
abstract::Many of the current drug therapies for androgenetic alopecia were discovered serendipitously, with hair growth observed as an off-target effect when drugs were used to treat a different disorder. Subsequently, several studies using cultured cells have enabled identification of hair growth modulators with similar prope...
journal_title:Regenerative medicine
pub_type: 杂志文章,评审
doi:10.2217/rme.13.87
更新日期:2014-01-01 00:00:00
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
更新日期:2006-01-01 00:00:00
abstract::Cord blood platelet gel is prepared by activation of coagulation in a platelet concentrate obtained from cord blood. During the process of clot formation, platelet alpha-granules release growth factors that promote tissue repair. However, in the form of gel, it is not possible to inject it into small, narrow and deep ...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme-2019-0074
更新日期:2020-01-01 00:00:00
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
更新日期:2020-07-01 00:00:00
abstract:AIM:To evaluate the in vitro immunogenic and immunomodulatory properties of induced pluripotent stem cells (iPSCs) compared with bone marrow-derived mesenchymal stromal cells (MSCs). MATERIALS & METHODS:Mouse embryonic fibroblasts (MEFs) were isolated from C3HeB/FeJ and C57BL/6J mice, and reprogrammed to generate iPSC...
journal_title:Regenerative medicine
pub_type: 杂志文章
doi:10.2217/rme.14.29
更新日期:2014-01-01 00:00:00
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
更新日期:2017-04-01 00:00:00
abstract::The Tissue Engineering and Regenerative Medicine International Society-Asia Pacific (TERMIS-AP) annual meeting was held in Sydney, Australia from 15-17 September 2010 and highlighted the latest developments in tissue engineering and regenerative medicine in the Asia-Pacific region. Several of the plenary lectures focu...
journal_title:Regenerative medicine
pub_type:
doi:10.2217/rme.11.7
更新日期:2011-03-01 00:00:00