Kazuhisa Doi
Japan
Research Article
Development of Artificial Cerebrospinal Fluid: Basic Experiments, and Phase II and III Clinical Trials
Author(s): Ryuzo Shiobara, Takayuki Ohira, Kazuhisa Doi, Masuhiro Nishimura and Takeshi KawaseRyuzo Shiobara, Takayuki Ohira, Kazuhisa Doi, Masuhiro Nishimura and Takeshi Kawase
Objectives: The first artificial cerebrospinal fluids (ACSFs), Elliot’s solutions A and B, were first reported in 1949.
In 1974, we developed an ACSF, ACSF trial product No. 1, and have safely used and developed this ACSF since
then (No.1 to No.19). In parallel with this, after performing basic experiments and clinical trials, we obtained marketing
approval for a commercially available ACSF (ARTCEREB) from the Japanese Ministry of Health, Labor, and Welfare
in 2008. We now present the results of those basic experiments and clinical studies, including the phase II and III trials
on ARTCEREB, with special reference to its safety and efficacy.
Methods: The composition and properties of ARTCEREB are as the same as human CSF, excluding the Clconcentration.
Experiments with rats: the significance of bicarbonate in ACSF, and the influenc.. View More»