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Article ; Online: Circulating immunophenotypes are potentially prognostic in follicular cell-derived thyroid cancer.

Kotwal, Anupam / Gustafson, Michael P / Bornschlegl, Svetlana / Dietz, Allan B / Delivanis, Danae / Ryder, Mabel

2024 Volume 14, Page(s) 1325343

Abstract: Background: Exploring the immune interface of follicular cell-derived thyroid cancer has prognostic and therapeutic potential. The available literature is lacking for comprehensive immunophenotyping in relation to clinical outcomes. In this study, we ... ...

Abstract	Background: Exploring the immune interface of follicular cell-derived thyroid cancer has prognostic and therapeutic potential. The available literature is lacking for comprehensive immunophenotyping in relation to clinical outcomes. In this study, we identify circulating immunophenotypes associated with thyroid cancer prognosis. Methods: We conducted a pilot observational study of adults with follicular cell-derived thyroid cancer who underwent surgery at our tertiary care referral center and had consented for flow cytometry on peripheral blood collected at the time of thyroidectomy. Results: Of the 32 included subjects, 20 (62%) had well differentiated, 5 (16%) had poorly differentiated, and 7 (22%) had anaplastic thyroid cancer. The most frequent AJCC stage was 4 (59%) and the ATA risk of recurrence category was high (56%). Patients with AJCC stage 3/4 demonstrated fewer circulating mononuclear cells (CD45+), more monocytes (CD14+), fewer total lymphocytes (CD14-), fewer T cells (CD3+), fewer CD4+ T cells, fewer gamma-delta T cells, fewer natural killer (NK) T-like cells, more myeloid-derived suppressor cells (MDSCs; Lin-CD33+HLADR-), and more effector memory T cells but similar CD8+ T cells compared to stage1/2. Immunophenotype comparisons by ATA risk stratification and course of thyroid cancer were comparable to those observed for stage, except for significant differences in memory T cell subtypes. The median follow-up was 58 months. Conclusions: Aggressive follicular cell-derived thyroid cancer either at presentation or during follow-up is associated with down-regulation of the T cell populations specifically CD4+ T cells, gamma-delta T cells, and NK T-like cells but up-regulation of MDSCs and altered memory T cells. These immunophenotypes are potential prognostic biomarkers supporting future investigation for developing targeted immunotherapies against advanced thyroid cancer.
MeSH term(s)	Adult ; Humans ; Prognosis ; Immunophenotyping ; CD8-Positive T-Lymphocytes ; CD4-Positive T-Lymphocytes ; Thyroid Neoplasms ; Adenocarcinoma, Follicular
Language	English
Publishing date	2024-01-03
Publishing country	Switzerland
Document type	Observational Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1325343
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Article: Tumor Microenvironment CD14

Schenk, Erin L / Boland, Jennifer M / Withers, Sarah G / Bulur, Peggy A / Dietz, Allan B

Cancers

2022 Volume 14, Issue 18

Abstract: Patients with early-stage lung adenocarcinoma have a high risk of recurrent or metastatic disease despite undergoing curative intent therapy. We hypothesized that increased CD14+ cells within the tumor microenvironment (TME) could stratify patient ... ...

Abstract	Patients with early-stage lung adenocarcinoma have a high risk of recurrent or metastatic disease despite undergoing curative intent therapy. We hypothesized that increased CD14+ cells within the tumor microenvironment (TME) could stratify patient outcomes. Immunohistochemistry for CD14 was performed on 189 specimens from patients with lung adenocarcinoma who underwent curative intent surgery. Outcomes and associations with clinical and pathologic variables were determined. In vitro studies utilized a coculture system to model the lung cancer TME containing CD14+ cells. Patients with high levels of TME CD14+ cells experienced a median overall survival of 5.5 years compared with 8.3 and 10.7 years for those with moderate or low CD14 levels, respectively (p < 0.001). Increased CD14+ cell tumor infiltration was associated with a higher stage at diagnosis and more positive lymph nodes at the time of surgery. This prognostic capacity remained even for patients with early-stage disease. Using an in vitro model system, we found that CD14+ cells reduced chemotherapy-induced cancer cell death. These data suggest that CD14+ cells are a biomarker for poor prognosis in early-stage lung adenocarcinoma and may promote tumor survival. CD14+ cell integration into the lung cancer TME can occur early in the disease and may be a promising new therapeutic avenue.
Language	English
Publishing date	2022-09-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14184501
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Article ; Online: Regenerative Materials for Surgical Reconstruction: Current Spectrum of Materials and a Proposed Method for Classification.

Sharma, Ayushman / Faubion, William A / Dietz, Allan B

Mayo Clinic proceedings

2019 Volume 94, Issue 10, Page(s) 2099–2116

Abstract: Chronic wound management is an enormous economic strain and quality-of-life issue for patients. Current treatments are ineffective or expensive and invasive. Materials (native and artificial) can act as the basis to enhance wound repair but often fall ... ...

Abstract	Chronic wound management is an enormous economic strain and quality-of-life issue for patients. Current treatments are ineffective or expensive and invasive. Materials (native and artificial) can act as the basis to enhance wound repair but often fall short of complete healing. The therapeutic index of materials have often been enhanced by combining them with drug or biologic elution technologies. Combination of materials with living drugs (cells) presents a new paradigm for enhancing therapy. Cell material interaction and therapeutic output will depend on variables ascribed to the living drug as well as variables ascribed to the underlying matrix. In this article, we review medical matrices currently approved by the US Food and Drug Administration (FDA) that would likely be the first generation of materials to be used in this manner. Currently there are hundreds of different materials on the market. Identification of the right combinations would benefit from a classification scheme to group materials with similar composition or derivation. We provide a classification scheme and FDA documentation references that should provide researchers and clinicians a starting point for testing these materials in the laboratory and rapidly transitioning cell therapies to the bedside.
MeSH term(s)	Biocompatible Materials/classification ; Humans ; Reconstructive Surgical Procedures ; Tissue Engineering ; Tissue Scaffolds/classification ; United States ; United States Food and Drug Administration ; Wound Healing
Chemical Substances	Biocompatible Materials
Language	English
Publishing date	2019-09-09
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	124027-4
ISSN	1942-5546 ; 0025-6196
ISSN (online)	1942-5546
ISSN	0025-6196
DOI	10.1016/j.mayocp.2019.03.013
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Article ; Online: Sensitive detection of integrated and free transcripts in chimeric antigen receptor T-cell manufactured cell products using droplet digital polymerase chain reaction.

Wiltshire, Timothy D / Milosevic, Dragana / Jacob, Eapen K / Grebe, Stefan K / Dietz, Allan B

Cytotherapy

2021 Volume 23, Issue 5, Page(s) 452–458

Abstract: Background aims: Viral vectors are commonly used to introduce chimeric antigen receptor (CAR) constructs into cell therapy products for the treatment of human disease. They are efficient at gene delivery and integrate into the host genome for subsequent ...

Abstract	Background aims: Viral vectors are commonly used to introduce chimeric antigen receptor (CAR) constructs into cell therapy products for the treatment of human disease. They are efficient at gene delivery and integrate into the host genome for subsequent replication but also carry risks if replication-competent lentivirus (RCL) remains in the final product. An optimal CAR T-cell product should contain sufficient integrated viral material and no RCL. Current product testing methods include cell-based assays with slow turnaround times and rapid quantitative polymerase chain reaction (PCR)-based assays that suffer from high result variability. The authors describe the development of a droplet digital PCR (ddPCR) method for detection of the vesicular stomatitis virus G glycoprotein envelope sequence, required for viral assembly, and the replication response element to measure integration of the CAR construct. Methods: Assay validation included precision, linearity, sensitivity, specificity and reproducibility over a range of low to high concentrations. Results: The limit of detection was 10 copies/μL, whereas negative samples showed <1.3 copies/μL. Within and between assay imprecision coefficients of variation across the reportable range (10-10 000 copies/μL) were <25%. Accuracy and linearity were verified by comparing known copy numbers with measured copy numbers (R Conclusions: DDPCR has excellent reproducibility, linearity, specificity and sensitivity for detecting RCL and assuring the safety of patient products in a rapid manner. The technique can also likely be adapted for the rapid detection of other targets during cell product manufacturing, including purity, potency and sterility assays.
MeSH term(s)	Humans ; Lentivirus/genetics ; Polymerase Chain Reaction ; Real-Time Polymerase Chain Reaction ; Receptors, Chimeric Antigen/genetics ; Reproducibility of Results ; T-Lymphocytes
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2021-03-11
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2020.12.012
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Article ; Online: Durable Response in Patients With Refractory Fistulizing Perianal Crohn's Disease Using Autologous Mesenchymal Stem Cells on a Dissolvable Matrix: Results from the Phase I Stem Cell on Matrix Plug Trial.

Dozois, Eric J / Lightner, Amy L / Dietz, Allan B / Fletcher, Joel G / Lee, Yong S / Friton, Jessica J / Faubion, William A

Diseases of the colon and rectum

2022 Volume 66, Issue 2, Page(s) 243–252

Abstract: Background: Refractory perianal Crohn's disease remains notoriously difficult to treat. We developed a novel technology using a commercially available bioabsorbable fistula plug to deliver autologous adipose-derived mesenchymal stem cells.: Objective!# ...

Abstract	Background: Refractory perianal Crohn's disease remains notoriously difficult to treat. We developed a novel technology using a commercially available bioabsorbable fistula plug to deliver autologous adipose-derived mesenchymal stem cells. Objective: This study aimed to assess therapeutic safety and feasibility in the completed STOMP (stem cells on matrix plugs) phase 1 clinical trial. Design: Prospective single-arm phase I clinical trial. Setting: Tertiary academic medical center. Patients: Adults (aged 18-65 y) with complex single-tract Crohn's disease perianal fistula who have failed conventional therapy were included in this study. Intervention: Autologous adipose-derived mesenchymal stem cells were isolated, ex vivo culture expanded, and seeded onto a commercially available bioabsorbable fistula plug. Six weeks later, patients returned to the operating room for removal of the seton and placement of the stem cell-loaded plug. Main outcome measures: Patients were followed up for a total of 8 visits through 12 months. Safety was the primary end point; clinical healing and MRI response were secondary end points. Results: Twenty patients (12 females; mean age 36 y) were treated with the stem cell-loaded plug. Of the 20 patients enrolled, 3 were not included in the 12-month analysis because of study withdrawal. Through 12 months, no patient experienced a serious adverse event related to the stem cell-loaded plug. Four patients experienced 7 serious adverse events and 12 patients experienced 22 adverse events. Complete clinical healing occurred in 14 of 18 patients at 6 months and 13 of 17 patients at 12 months. MRI response was observed in 12 of 18 patients at 6 months. Limitations: The main limitations were the small sample size and restrictive inclusion criteria. Conclusions: A stem cell-loaded plug can safely and effectively deliver cell-based therapy for patients with single-tract fistulizing perianal Crohn's disease. See Video Abstract at http://links.lww.com/DCR/C70 . Respuesta duradera observada en pacientes con enfermedad de crohn perianal fistulizante refractaria mediante el uso de clulas madre mesenquimales autlogas en una matriz disoluble resultados del ensayo de fase i stem cell on matrix plug: ANTECEDENTES:La enfermedad de Crohn perianal refractaria sigue siendo notoriamente difícil de tratar. Desarrollamos una tecnología novedosa utilizando un tapón de fístula bioabsorbible disponible comercialmente para administrar células madre mesenquimales derivadas de tejido adiposo autólogo.OBJETIVO:Evaluar la seguridad y viabilidad terapéutica en el ensayo finalizado STOMP.DISEÑO:Ensayo clínico prospectivo de fase I de un solo brazo.AJUSTE:Centro médico académico terciario.PACIENTES:Adultos (18-65) con fístula perianal compleja de la enfermedad de Crohn de un solo tracto que han fracasado con la terapia convencional.INTERVENCIÓN:Se aislaron células madre mesenquimales derivadas de tejido adiposo autólogo, se expandieron en cultivo ex vivo y se sembraron en un tapón de fístula bioabsorbible disponible comercialmente. Seis semanas después, los pacientes regresaron al quirófano para retirar el setón y colocar el tapón cargado de células madre.PRINCIPALES MEDIDAS DE RESULTADO:Los pacientes fueron seguidos durante un total de 8 visitas durante 12 meses. La seguridad fue el criterio principal de valoración; la curación clínica y la respuesta a la resonancia magnética fueron criterios de valoración secundarios.RESULTADOS:Veinte pacientes (12 mujeres, edad media 36 años) fueron tratados con el tapón cargado de células madre. De los 20 pacientes inscritos, tres no se incluyeron en el análisis de 12 meses porque se retiraron del estudio. A lo largo de 12 meses, ningún paciente experimentó un evento adverso grave relacionado con el tapón cargado de células madre. Cuatro pacientes experimentaron 7 eventos adversos graves y 12 pacientes experimentaron 22 eventos adversos. La curación clínica completa ocurrió en 14 de 18 pacientes a los 6 meses y en 13 de 17 pacientes a los 12 meses. La respuesta a la resonancia magnética se observó en 12 de 18 pacientes a los 6 meses.LIMITACIONES:Las principales limitaciones son el tamaño pequeño de la muestra y los criterios de inclusión restrictivos.CONCLUSIONES:Un tapón cargado de células madre se puede administrar de manera segura y efectiva, una terapia basada en células para pacientes con enfermedad de Crohn perianal fistulizante de un solo tracto. Consule Video Resumen en http://links.lww.com/DCR/C70 . (Traducción- Dr. Yesenia Rojas-Khalil ).
MeSH term(s)	Adult ; Female ; Humans ; Crohn Disease/complications ; Crohn Disease/therapy ; Mesenchymal Stem Cells ; Prospective Studies ; Rectal Fistula/etiology ; Rectal Fistula/therapy ; Retrospective Studies ; Stem Cells
Language	English
Publishing date	2022-11-21
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	212581-x
ISSN	1530-0358 ; 0012-3706
ISSN (online)	1530-0358
ISSN	0012-3706
DOI	10.1097/DCR.0000000000002579
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Article ; Online: Promise of autologous CD34+ stem/progenitor cell therapy for treatment of cardiovascular disease.

Prasad, Megha / Corban, Michel T / Henry, Timothy D / Dietz, Allan B / Lerman, Lilach O / Lerman, Amir

Cardiovascular research

2020 Volume 116, Issue 8, Page(s) 1424–1433

Abstract: CD34+ cells are haematopoietic stem cells used therapeutically in patients undergoing radiation or chemotherapy due to their regenerative potential and ability to restore the haematopoietic system. In animal models, CD34+ cells have been associated with ... ...

Abstract	CD34+ cells are haematopoietic stem cells used therapeutically in patients undergoing radiation or chemotherapy due to their regenerative potential and ability to restore the haematopoietic system. In animal models, CD34+ cells have been associated with therapeutic angiogenesis in response to ischaemia. Several trials have shown the potential safety and efficacy of CD34+ cell delivery in various cardiovascular diseases. Moreover, Phase III trials have now begun to explore the potential role of CD34+ cells in treatment of both myocardial and peripheral ischaemia. CD34+ cells have been shown to be safe and well-tolerated in the acute myocardial infarction (AMI), heart failure, and angina models. Several studies have suggested potential benefit of CD34+ cell therapy in patients with coronary microvascular disease as well. In this review, we will discuss the therapeutic potential of CD34+ cells, and describe the pertinent trials that have used autologous CD34+ cells in no-options refractory angina, AMI, and heart failure. Lastly, we will review the potential utility of autologous CD34+ cells in coronary endothelial and microvascular dysfunction.
MeSH term(s)	Animals ; Antigens, CD34/metabolism ; Cardiovascular Diseases/pathology ; Cardiovascular Diseases/physiopathology ; Cardiovascular Diseases/surgery ; Cardiovascular System/pathology ; Cardiovascular System/physiopathology ; Endothelial Progenitor Cells/metabolism ; Endothelial Progenitor Cells/transplantation ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cells/metabolism ; Humans ; Phenotype ; Recovery of Function ; Regeneration
Chemical Substances	Antigens, CD34
Language	English
Publishing date	2020-02-18
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	80340-6
ISSN	1755-3245 ; 0008-6363
ISSN (online)	1755-3245
ISSN	0008-6363
DOI	10.1093/cvr/cvaa027
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Article ; Online: Biodegradable biliary stents coated with mesenchymal stromal cells in a porcine choledochojejunostomy model.

Hosseiniasl, Seyed M / Felgendreff, Philipp / Tharwat, Mohammad / Amiot, Bruce / AbuRmilah, Anan / Minshew, Anna M / Bornschlegl, Alexander M / Jalan-Sakrikar, Nidhi / Smart, Michele / Dietz, Allan B / Huebert, Robert C / Nyberg, Scott L

Cytotherapy

2023 Volume 25, Issue 5, Page(s) 483–489

Abstract: Background aims: Roux en y anastomosis is a preferred method of biliary reconstruction in liver transplantation that involves living donors or pediatric patients. However, biliary stricture is a frequent and serious complication, accounting for up to 40% ...

Abstract	Background aims: Roux en y anastomosis is a preferred method of biliary reconstruction in liver transplantation that involves living donors or pediatric patients. However, biliary stricture is a frequent and serious complication, accounting for up to 40% of biliary complications in these patients. Previously, we demonstrated that extraluminal delivery of adipose-derived (AD) mesenchymal stromal cells (MSCs) decreased peri-biliary fibrosis and increased neo-angiogenesis in a porcine model of duct-to-duct biliary anastomosis. In this study, we used a porcine model of Roux en y anastomosis to evaluate the beneficial impact of a novel intraluminal MSC delivery system. Methods: Nine animals were divided into three groups: no stent (group 1), bare stent (group 2) and stent coated with AD-MSCs (group 3). All animals underwent cholecystectomy with roux en y choledochojejunostomy. Two animals per group were followed for 4 weeks and one animal per group was followed for 8 weeks. Cholangiograms and blood were sampled at baseline and the end of study. Biliary tissue was collected and examined by Masson trichrome staining and immunohistochemical staining for MSC markers (CD34 and CD44) and for neo-angiogenesis (CD31). Results: Two of three animals in group 1 developed an anastomotic site stricture. No strictures were observed in the animals of group 2 or group 3. CD34 and CD44 staining showed that AD-MSCs engrafted successfully at the anastomotic site by intraluminal delivery (group 3). Furthermore, biliary tissue from group 3 showed significantly less fibrosis and increased angiogenesis compared with the other groups. Conclusions: Intraluminal delivery of AD-MSCs resulted in successful biliary engraftment of AD-MSCs as well as reduced peri-biliary fibrosis and increased neo-angiogenesis.
MeSH term(s)	Swine ; Animals ; Choledochostomy ; Biliary Tract Surgical Procedures/methods ; Anastomosis, Roux-en-Y ; Fibrosis ; Mesenchymal Stem Cells ; Postoperative Complications ; Retrospective Studies ; Treatment Outcome
Language	English
Publishing date	2023-02-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2023.01.014
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Article: Gene expression profiles of human adipose-derived mesenchymal stem cells dynamically seeded on clinically available processed nerve allografts and collagen nerve guides.

Mathot, Femke / Rbia, Nadia / Thaler, Roman / Dietz, Allan B / van Wijnen, Andre J / Bishop, Allen T / Shin, Alexander Y

Neural regeneration research

2021 Volume 16, Issue 8, Page(s) 1613–1621

Abstract: It was hypothesized that mesenchymal stem cells (MSCs) could provide necessary trophic factors when seeded onto the surfaces of commonly used nerve graft substitutes. We aimed to determine the gene expression of MSCs when influenced by Avance® Nerve ... ...

Abstract	It was hypothesized that mesenchymal stem cells (MSCs) could provide necessary trophic factors when seeded onto the surfaces of commonly used nerve graft substitutes. We aimed to determine the gene expression of MSCs when influenced by Avance® Nerve Grafts or NeuraGen® Nerve Guides. Human adipose-derived MSCs were cultured and dynamically seeded onto 30 Avance® Nerve Grafts and 30 NeuraGen® Nerve Guides for 12 hours. At six time points after seeding, quantitative polymerase chain reaction analyses were performed for five samples per group. Neurotrophic [nerve growth factor (NGF), glial cell line-derived neurotrophic factor (GDNF), pleiotrophin (PTN), growth associated protein 43 (GAP43) and brain-derived neurotrophic factor (BDNF)], myelination [peripheral myelin protein 22 (PMP22) and myelin protein zero (MPZ)], angiogenic [platelet endothelial cell adhesion molecule 1 (PECAM1/CD31) and vascular endothelial cell growth factor alpha (VEGFA)], extracellular matrix (ECM) [collagen type alpha I (COL1A1), collagen type alpha III (COL3A1), Fibulin 1 (FBLN1) and laminin subunit beta 2 (LAMB2)] and cell surface marker cluster of differentiation 96 (CD96) gene expression was quantified. Unseeded Avance® Nerve Grafts and NeuraGen® Nerve Guides were used to evaluate the baseline gene expression, and unseeded MSCs provided the baseline gene expression of MSCs. The interaction of MSCs with the Avance® Nerve Grafts led to a short-term upregulation of neurotrophic (NGF, GDNF and BDNF), myelination (PMP22 and MPZ) and angiogenic genes (CD31 and VEGFA) and a long-term upregulation of BDNF, VEGFA and COL1A1. The interaction between MSCs and the NeuraGen® Nerve Guide led to short term upregulation of neurotrophic (NGF, GDNF and BDNF) myelination (PMP22 and MPZ), angiogenic (CD31 and VEGFA), ECM (COL1A1) and cell surface (CD96) genes and long-term upregulation of neurotrophic (GDNF and BDNF), angiogenic (CD31 and VEGFA), ECM genes (COL1A1, COL3A1, and FBLN1) and cell surface (CD96) genes. Analysis demonstrated MSCs seeded onto NeuraGen® Nerve Guides expressed significantly higher levels of neurotrophic (PTN), angiogenic (VEGFA) and ECM (COL3A1, FBLN1) genes in the long term period compared to MSCs seeded onto Avance® Nerve Grafts. Overall, the interaction between human MSCs and both nerve graft substitutes resulted in a significant upregulation of the expression of numerous genes important for nerve regeneration over time. The in vitro interaction of MSCs with the NeuraGen® Nerve Guide was more pronounced, particularly in the long term period (> 14 days after seeding). These results suggest that MSC-seeding has potential to be applied in a clinical setting, which needs to be confirmed in future in vitro and in vivo research.
Language	English
Publishing date	2021-01-11
Publishing country	India
Document type	Journal Article
ZDB-ID	2388460-5
ISSN	1876-7958 ; 1673-5374
ISSN (online)	1876-7958
ISSN	1673-5374
DOI	10.4103/1673-5374.303031
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Article ; Online: Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial).

Piryani, Ameet K / Kilari, Sreenivasulu / Takahashi, Edwin / DeMartino, Randall R / Mandrekar, Jay / Dietz, Allan B / Misra, Sanjay

Kidney360

2021 Volume 2, Issue 12, Page(s) 1945–1952

Abstract: Background: Hemodialysis arteriovenous fistulas (AVFs) are the preferred vascular access for patients on hemodialysis. In the Hemodialysis Fistula Maturation Study, 44% of the patients achieved unassisted maturation of their fistula without needing an ... ...

Abstract	Background: Hemodialysis arteriovenous fistulas (AVFs) are the preferred vascular access for patients on hemodialysis. In the Hemodialysis Fistula Maturation Study, 44% of the patients achieved unassisted maturation of their fistula without needing an intervention. Venous neointimal hyperplasia (VNH) and subsequent venous stenosis are responsible for lack of maturation. There are no therapies that can prevent VNH/VS formation. The goal of this paper is to present the background, rationale, and trial design of an innovative phase 1/2 clinical study that is investigating the safety of autologous adipose-derived mesenchymal stem cells delivered locally to the adventitia of newly created upper extremity radiocephalic (RCF) or brachiocephalic fistula (BCF). Methods: The rationale and preclinical studies used to obtain a physician-sponsored investigational new drug trial are discussed. The trial design and end points are discussed. Results: This is an ongoing trial that will complete this year. Conclusion: This is a phase 1/2 single-center, randomized trial that will investigate the safety and efficacy of autologous AMSCs in promoting maturation in new upper-extremity AVFs.
MeSH term(s)	Arteriovenous Fistula/etiology ; Arteriovenous Fistula/prevention & control ; Arteriovenous Shunt, Surgical/adverse effects ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Constriction, Pathologic/etiology ; Constriction, Pathologic/prevention & control ; Humans ; Mesenchymal Stem Cells ; Neointima ; Randomized Controlled Trials as Topic ; Renal Dialysis
Language	English
Publishing date	2021-09-28
Publishing country	United States
Document type	Controlled Clinical Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2641-7650
ISSN (online)	2641-7650
DOI	10.34067/KID.0005182021
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Article ; Online: Human meniscus allograft augmentation by allogeneic mesenchymal stromal/stem cell injections.

Struijk, Caroline / Van Genechten, Wouter / Verdonk, Peter / Krych, Aaron J / Dietz, Allan B / van Wijnen, Andre J / Saris, Daniel B F

Journal of orthopaedic research : official publication of the Orthopaedic Research Society

2021 Volume 40, Issue 3, Page(s) 712–726

Abstract: Meniscus allograft transplantations (MATs) represent established surgical procedures with proven outcomes. Yet, storage as frozen specimens and limited cellular repopulation may impair graft viability. This proof-of-concept study tests the feasibility of ...

Abstract	Meniscus allograft transplantations (MATs) represent established surgical procedures with proven outcomes. Yet, storage as frozen specimens and limited cellular repopulation may impair graft viability. This proof-of-concept study tests the feasibility of injecting allogeneic mesenchymal stromal/stem cells (MSCs) in meniscus allograft tissue. We investigated the injectable cell quantity, survival rate, migration, and proliferation ability of MSCs up to 28 days of incubation. In this controlled laboratory study, seven fresh-frozen human allografts were injected with human allogeneic MSCs. Cells were labeled and histological characteristics were microscopically imaged up to 28 days. Mock-injected menisci were included as negative controls in each experiment. Toluidine blue staining demonstrated that a 100-µl volume can be injected while retracting and rotating the inserted needle. Immediately after injection, labeled MSCs were distributed throughout the injection channel and eventually migrated into the surrounding tissues. Histological assessment revealed that MSCs cluster in disc-like shapes, parallel to the intrinsic lamination of the meniscus and around the vascular network. Quantification showed that more than 60% of cells were present in horizontally injected grafts and more than 30% were observed in vertically injected samples. On Day 14, cells adopted a spindle-shaped morphology and exhibited proliferative and migratory behaviors. On Day 28, live/dead ratio assessment revealed an approximately 80% cell survival. The study demonstrated the feasibility of injecting doses of MSCs (>0.1 million) in meniscus allograft tissue with active cell proliferation, migration, and robust cell survival.
MeSH term(s)	Allografts ; Hematopoietic Stem Cell Transplantation ; Humans ; Meniscus ; Mesenchymal Stem Cell Transplantation/methods ; Mesenchymal Stem Cells ; Transplantation, Homologous
Language	English
Publishing date	2021-05-24
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	605542-4
ISSN	1554-527X ; 0736-0266
ISSN (online)	1554-527X
ISSN	0736-0266
DOI	10.1002/jor.25074
Database	MEDical Literature Analysis and Retrieval System OnLINE

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