Patient Phase

A meeting with the patient and someone from her or his family is planned to explain the indication for lead extraction, procedural strategy plan, possible risks and complications for the specific case (showing the performance of the team in similar cases), and pre- and postprocedural preparation and care. At the end of the meeting, a written informed consent is obtained, and the preoperative checklist is completed. 

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Proof-of-concept studies in patients (Phase II) Preclinical support... 

Pre-clinical trials (as well as phase I and II clinical trials) utilizing CNTF yielded promising results, but the neurotrophic factor then failed phase III clinical trials on the basis of insufficient efficacy. However, myotrophin (IGF-1, produced by Cephalon Inc.) has proved more successful. A 266 patient phase III clinical study found that IGF-1 administration to ALS sufferers resulted in reduced severity of symptoms, and slower disease progression, although this or no related product has yet been approved for medical use. The potential world market for an ALS therapeutic agent approaches 1 billion. 

Haas et al. (167) HIV infection 31 patients Phase 1 viral decay No statistical difference... 

Does it work and is it safe in a smaii number of patients (Phase il ciinicai triais)... 

Rajagopalan S, Olin J, Deitcher S, Pieczek A, Laird J, Gross-man PM, Goldman CK, McEllin K, Kelly R, Chronos N. Use of a constitutively active hypoxia-inducible factor-1 alpha transgene as a therapeutic strategy in no-option critical limb ischemia patients phase I dose-escalation experience. Circulation 2007 115 1234-1243. 

AVET Polylysine-modified Tf+adenovirus Plasmid Ex vivo, transfected autologous melanoma cells, cells injected into the patient (Phase 1) 170... 

In Germany, Bayer and Hoechst investigated a polysulfated polyxylan (Hoe/Bay 946) with the m.w. 6 kDa for its in vitro anti-HIV-activity [64]. The polyanion polysaccharide was able, at a concentration of 25 Lig/ml, to totally inhibit the HIV-reverse transcriptase and the HIV-induced syncytia formation of T lymphocytes. The in vitro and experimental animal studies were followed by an open, clinical trial with HIV-infected patients (phase I, III and IV, cluster of differentiation classification (CDC)). Hoe/Bay 946 was applied orally in a concentration of 3 X 150 mg and 3 x 450 mg/day for 12 months. The therapy was well tolerated by all patients. In patients in phase II + III, the peripheral lymphocytes increased from 2500 to 2785/ li1, the T4 lymphocytes from 460 to 560/ li1 whereas the ratio decreased from 0.50 to 0.475. 

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