BOOST trial

Most of the clinical experience gained with stem cells has involved therapy for AMI, particularly intracoronary infusion of bone marrow cells since skeletal myoblasts are too large for this purpose [133]. Table 7.2 summarizes the experience to date. In all of these trials, revascularization was performed promptly after the index myocardial infarction, and left ventricular systolic compromise was minor (in the BOOST trial, the baseline left ventricular ejection fraction [LVEF] was 50%). 

In the randomized BOOST trial [112], patients received either bone marrow-derived ABMMNCs... 

The 18-month follow-up of patients in the BOOST trial was recently published [135]. The initial improvement in LVEF in the cell-treated group was not sustained when compared to the control group. However, the speed in which there was LVEF recovery over the 18 months was significantly higher in the cell-treated group. 

Meyer, G. R, WoUert, K. C., Lotz, J., Pirr, J., Rager, U., Lippolt, R, Hahn, A., Fichtner, S., Schaefer, A., Arseniev, L., Ganser, A., and Drexler, H. 2009. Intracoronary bone marrow cell transfer after myocardial infarction 5-year follow-up from the randomized-controlled Boost trial. Eur. Heart J., 30, 2978-2984. 

Elvitegravir (18, GS-9137, JTK-303, EVG) is the second IN strand transfer inhibitor to advance into phase III clinical trials (Figure 7). EVG was derived from the quinolone antibiotics which do not show IN activity [39-41]. Through careful optimization, this work resulted in EVG displaying enzyme and antiviral activity of 7.2 and 0.9 nM, respectively. EVG has moderate bioavailability in preclinical species (29 and 34%), low clearance (Qp 0.5 and l.OL/h/kg) and a moderate half-life of 2.3 and 5.2h in rats and dogs, respectively [42]. It is primarily metabolized via CYP450 oxidation and shows a marked increase in human exposure with RTV boosting. 

The sera of mice fed with fresh spinach leaves infected with AlMV particles presenting a rabies virus epitope contained IgG and IgA. Mucosal IgA was also detected [48]. Human volunteers (in FDA approved trials) fed with spinach containing recombinant particles generated both IgG and IgA responses specific to the pathogen [49]. The trials also suggested that plant virus particle-based vaccines could be effectively used in prime-boost regimens. In more recent work, recombinant AlMV particles containing an epitope from the G protein of human respiratory syncytial virus (RSV) induced protective immunity in mice [33]. 

Although IL-2 has not been approved to treat HIV/AIDS, many clinical trials using IL-2 are being conducted. The strategy is to complement the anti-HIV therapy by boosting the immune system with IL-2. The replacement... 

A secondary objective of the trial compared whole brain irradiation with a regimen involving some whole brain combined with a focal coned-down boost. Patients accrued in 1980 and 1981 received 60.2 Gy to the whole brain in 1.72 Gy fractions concurrent with the first course of chemotherapy. Patients accrued after that time were randomly assigned to either whole-brain irradiation as above or 43.0 Gy whole-brain irradiation plus a... 

Janjan NA, Crane CN, Feig BW, et al. Prospective trial of preoperative concomitant boost radiotherapy with continuous infusion 5 -fluorouracil for locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 2000 47 713-718. 

B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronaiy autologous bone-marrow cell transfer after myocardial infarction the BOOST randomised controlled clinical trial. Lancet 2004 364 141-148. 

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