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Intramyocardial injection of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction (First Mononuclear Cells injected in the US [FOCUS]): Rationale and design.
Willerson JT, Perin EC, Ellis SG, Pepine CJ, Henry TD, Zhao DX, Lai D, Penn MS, Byrne BJ, Silva G, Gee A, Traverse JH, Hatzopoulos AK, Forder JR, Martin D, Kronenberg M, Taylor DA, Cogle CR, Baraniuk S, Westbrook L, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moyé LA, Simari RD, Cardiovascular Cell Therapy Research Network (CCTRN)
(2010) Am Heart J 160: 215-23
MeSH Terms: Bone Marrow Transplantation, Chronic Disease, Humans, Injections, Intralesional, Leukocytes, Mononuclear, Linear Models, Myocardial Ischemia, Outcome Assessment, Health Care, Research Design, Tomography, Emission-Computed, Single-Photon, Transplantation, Autologous, Ventricular Dysfunction, Left
Show Abstract · Added November 18, 2010
BACKGROUND - The increasing worldwide prevalence of coronary artery disease (CAD) continues to challenge the medical community. Management options include medical and revascularization therapy. Despite advances in these methods, CAD is a leading cause of recurrent ischemia and heart failure, posing significant morbidity and mortality risks along with increasing health costs in a large patient population worldwide.
TRIAL DESIGN - The Cardiovascular Cell Therapy Research Network (CCTRN) was established by the National Institutes of Health to investigate the role of cell therapy in the treatment of chronic cardiovascular disease. FOCUS is a CCTRN-designed randomized, phase II, placebo-controlled clinical trial that will assess the effect of autologous bone marrow mononuclear cells delivered transendocardially to patients with left ventricular (LV) dysfunction and symptomatic heart failure or angina. All patients need to have limiting ischemia by reversible ischemia on single-photon emission computed tomography assessment.
RESULTS - After thoughtful consideration of both statistical and clinical principles, we will recruit 87 patients (58 cell treated and 29 placebo) to receive either bone marrow-derived stem cells or placebo. Myocardial perfusion, LV contractile performance, and maximal oxygen consumption are the primary outcome measures.
CONCLUSIONS - The designed clinical trial will provide a sound assessment of the effect of autologous bone marrow mononuclear cells in improving blood flow and contractile function of the heart. The target population is patients with CAD and LV dysfunction with limiting angina or symptomatic heat failure. Patient safety is a central concern of the CCTRN, and patients will be followed for at least 5 years.
Copyright 2010 Mosby, Inc. All rights reserved.
1 Communities
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12 MeSH Terms
Obesity did not diminish the efficacy of percutaneous ablation for hepatocellular carcinoma.
Ohki T, Tateishi R, Shiina S, Sato T, Masuzaki R, Yoshida H, Kanai F, Obi S, Yoshida H, Omata M
(2007) Liver Int 27: 360-7
MeSH Terms: Aged, Carcinoma, Hepatocellular, Catheter Ablation, Ethanol, Female, Humans, Injections, Intralesional, Liver Neoplasms, Male, Microwaves, Neoplasm Recurrence, Local, Obesity, Survival Rate, Treatment Outcome
Show Abstract · Added May 2, 2014
BACKGROUND - Overweight and hepatic steatosis can increase the risk of hepatocarcinogenesis. In addition, overweight may affect the treatment efficacy of ultrasound-guided percutaneous ablation. We evaluated the impact of overweight on the safety and efficacy of percutaneous ablation to hepatocellular carcinoma (HCC).
METHODS - We enrolled 743 patients with naïve HCC who were treated by percutaneous ablation including ethanol injection, microwave coagulation, and radiofrequency ablation (RFA) between 1995 and 2003. Patients were divided into two groups by body mass index (BMI): 219 overweight patients with BMI>25 kg/m2 and 524 control patients with BMIRESULTS - The overweight group required a significantly larger number of sessions by RFA (P=0.01). Major complications were identified in 8.7% in the overweight group and 7.6% in the control group (P=0.94). There was no significant difference in cumulative recurrence rate and local tumor-progression rate between the two groups (P=0.63 and 0.44). Cumulative survival rates at 1, 3, and 5 years were 95.4%, 75.7%, and 57.8%, respectively, in the overweight group and 94.1%, 78.0%, and 58.8% in the control group (P=0.99).
CONCLUSIONS - The results indicated that overweight did not increase complications nor affect HCC recurrence and overall survival. However, the number of sessions of RFA was significantly greater in overweight patients, suggesting that overweight was associated with minor technical difficulties.
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14 MeSH Terms
Effects of systemic and local administration of recombinant human IGF-I (rhIGF-I) on de novo bone formation in an aged mouse model.
Fowlkes JL, Thrailkill KM, Liu L, Wahl EC, Bunn RC, Cockrell GE, Perrien DS, Aronson J, Lumpkin CK
(2006) J Bone Miner Res 21: 1359-66
MeSH Terms: Aging, Animals, Electron Probe Microanalysis, Humans, Injections, Intralesional, Insulin-Like Growth Factor I, Male, Mice, Mice, Inbred C57BL, Models, Animal, Models, Biological, Osteogenesis, Osteotomy, Radiography, Recombinant Proteins, Tibia
Show Abstract · Added April 25, 2013
UNLABELLED - DO was used in an aged mouse model to determine if systemically and/or locally administered rhIGF-I improved osteoblastogenesis and new bone formation. Local and systemic rhIGF-I treatment increased new bone formation. However, only systemic delivery produced measurable concentrations of rhIGF-I in the circulation.
INTRODUCTION - Human and rodent research supports a primary role for IGF-I in bone formation. Significant roles for both endocrine and paracrine/autocrine IGF-I have been suggested for normal osteoblastogenesis and bone formation. We have assessed, using a mouse model of distraction osteogenesis (DO), the impact of continuous administration of recombinant human (rh)IGF-I, delivered either locally to the distraction site or absorbed systemically, on bone formation in an aged mouse model.
MATERIALS AND METHODS - DO was performed in aged mice (18-month-old C57BL/6 male mice), which were distracted at 0.15 mm daily. At the time of osteotomy, miniosmotic pumps were inserted subcutaneously to (1) deliver vehicle or rhIGF-I subcutaneously for systemic delivery or (2) deliver vehicle or rhIGF-I directly to the newly forming bone through infusion tubing routed subcutaneously from the pump to the distraction site. Serum concentrations of mouse IGF-I, human IGF-I, and osteocalcin were determined at the end of the study.
RESULTS - New bone formation observed in DO gaps showed a significant increase in new bone formation in rhIGF-I-treated mice, irrespective of delivery route. However, detectable levels of human IGF-I were found only in the serum of animals receiving rhIGF-I systemically. Osteocalcin levels did not differ between controls and rhIGF-I-treated groups.
CONCLUSIONS - Locally and systemically delivered rhIGF-I both produce significant increases in new bone formed in an aged mouse model in which new bone formation is normally markedly impaired, suggesting that rhIGF-I may improve senile osteoporosis. Because systemic administration of IGF-I can result in untoward side effects, including an increased risk for cancer, the findings that locally delivered IGF-I improves bone regeneration without increasing circulating IGF-I levels suggests that this delivery route may be preferable in an at-risk, aged population.
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16 MeSH Terms
Nuclear factor-kappaB affects tumor progression in a mouse model of malignant pleural effusion.
Stathopoulos GT, Zhu Z, Everhart MB, Kalomenidis I, Lawson WE, Bilaceroglu S, Peterson TE, Mitchell D, Yull FE, Light RW, Blackwell TS
(2006) Am J Respir Cell Mol Biol 34: 142-50
MeSH Terms: Animals, Body Fluids, Carcinoma, Lewis Lung, Chemokine CCL2, Disease Models, Animal, Female, Green Fluorescent Proteins, I-kappa B Proteins, Injections, Intralesional, L-Lactate Dehydrogenase, Male, Mice, Mice, Inbred C57BL, Monocyte Chemoattractant Proteins, NF-kappa B, Pleural Effusion, Malignant, Pleural Neoplasms, Pregnancy
Show Abstract · Added February 26, 2013
We developed a novel mouse model of malignant pleural effusion (MPE) by injecting Lewis lung cancer (LLC) cells directly into the pleural space of syngeneic C57B/6 mice. The pleural effusions in this model share common cellular and biochemical features with human MPEs. Implantation and growth of pleural tumors triggers a host inflammatory response characterized by a mixed inflammatory cell influx into the pleural fluid. LLC cells exhibited high basal nuclear factor (NF)-kappaB activity in vitro and in vivo, which we used to drive expression of a NF-kappaB-dependent green fluorescent protein-firefly luciferase fusion reporter construct. NF-kappaB-dependent reporter expression allowed intravital tracing of pleural tumors. Inhibition of NF-kappaB in LLC cells did not affect cell viability in culture; however, injection of LLC cells expressing a dominant NF-kappaB inhibitor resulted in decreased tumor burden, decreased pleural effusion volume, and decreased pleural effusion TNF-alpha levels. These studies indicate that tumor NF-kappaB activity regulates pleural tumor progression. This reproducible model of MPE can be used to further study the influence of specific host and tumor factors on the pathogenesis of MPE and evaluate new therapeutic strategies.
2 Communities
4 Members
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18 MeSH Terms
Inclusion of the herpes simplex thymidine kinase gene in a replicating adenovirus does not augment antitumor efficacy.
Lambright ES, Amin K, Wiewrodt R, Force SD, Lanuti M, Propert KJ, Litzky L, Kaiser LR, Albelda SM
(2001) Gene Ther 8: 946-53
MeSH Terms: Adenoviridae, Analysis of Variance, Animals, Antiviral Agents, Female, Ganciclovir, Genetic Therapy, Genetic Vectors, Injections, Intralesional, Lung Neoplasms, Male, Mice, Mice, Nude, Mice, SCID, Neoplasm Transplantation, Neoplasms, Experimental, Simplexvirus, Thymidine Kinase, Transduction, Genetic, Virus Replication
Show Abstract · Added March 5, 2014
Replication-incompetent adenoviruses (Ad) carrying the herpes simplex thymidine kinase (HSVtk) gene have been used in a number of human cancer gene therapy trials, however transduction has generally been limited to a small minority of tumor cells. To solve this problem, replication-competent adenoviral vectors carrying transgenes such as HSVtk have been developed. However, contradictory evidence exists regarding the efficacy of these new vectors. Accordingly, we constructed and tested a replication-competent E3-deleted adenoviral vector containing the HSVtk suicide gene driven by the endogenous E3 promoter (Ad.wt.tk). This virus showed high level production of the HSVtk transgene and was more efficacious than a non-replicating virus in vitro, after injection into flank tumors, and against established intraperitoneal tumors. However, addition of ganciclovir (GCV) therapy to cells or tumor-bearing animals treated with the replicating vector containing the HSVtk suicide gene did not result in increased cell killing. Our results indicate that addition of HSVtk to a replicating Ad virus will not likely be useful in augmenting antitumor effects.
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20 MeSH Terms
Adenovirus-mediated p53 gene transfer in sequence with cisplatin to tumors of patients with non-small-cell lung cancer.
Nemunaitis J, Swisher SG, Timmons T, Connors D, Mack M, Doerksen L, Weill D, Wait J, Lawrence DD, Kemp BL, Fossella F, Glisson BS, Hong WK, Khuri FR, Kurie JM, Lee JJ, Lee JS, Nguyen DM, Nesbitt JC, Perez-Soler R, Pisters KM, Putnam JB, Richli WR, Shin DM, Walsh GL, Merritt J, Roth J
(2000) J Clin Oncol 18: 609-22
MeSH Terms: Adenoviruses, Human, Adult, Aged, Antibodies, Viral, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Cisplatin, Combined Modality Therapy, DNA Mutational Analysis, DNA, Neoplasm, Female, Gene Transfer Techniques, Genes, p53, Genetic Vectors, Humans, In Situ Nick-End Labeling, Injections, Intralesional, Lung Neoplasms, Male, Middle Aged, Organ Specificity, Staining and Labeling
Show Abstract · Added March 5, 2014
PURPOSE - To determine the safety and tolerability of adenovirus-mediated p53 (Adp53) gene transfer in sequence with cisplatin when given by intratumor injection in patients with non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS - Patients with advanced NSCLC and abnormal p53 function were enrolled onto cohorts receiving escalating dose levels of Adp53 (1 x 10(6) to 1 x 10(11) plaque-forming units [PFU]). Patients were administered intravenous cisplatin 80 mg/m(2) on day 1 and study vector on day 4 for a total of up to six courses (28 days per course). Apoptosis was determined by the terminal deoxynucleotidyl- transferase-dUTP nick-end labeling assay. Evidence of vector-specific sequences were determined using reverse-transcriptase polymerase chain reaction. Vector dissemination and biodistribution was monitored using a series of assays (cytopathic effects assay, Ad5 hexon enzyme-linked immunosorbent assay, vector-specific polymerase chain reaction assay, and antibody response assay).
RESULTS - Twenty-four patients (median age, 64 years) received a total of 83 intratumor injections with Adp53. The maximum dose administered was 1 x 10(11) PFU per dose. Transient fever related to Adp53 injection developed in eight of 24 patients. Seventeen patients achieved a best clinical response of stable disease, two patients achieved a partial response, four patients had progressive disease, and one patient was not assessable. A mean apoptotic index between baseline and follow-up measurements increased from 0.010 to 0.044 (P =.011). Intratumor transgene mRNA was identified in 43% of assessable patients.
CONCLUSION - Intratumoral injection with Adp53 in combination with cisplatin is well tolerated, and there is evidence of clinical activity.
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22 MeSH Terms