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Cerebral Spinal Fluid Sampling

Describing pharmacokinetic/pharmacodynamic relationships have never been more important in the drug development process -- both as a reflection of a resurgence in biomarker research for disease modification agents, and as a complementary approach toward understanding the pharmacological basis of unique,” first in class" therapeutics.

Cerebral Spinal Fluid (CSF) sampling can confirm brain penetration of psychotropic agents, their PK profile in the brain, and action on neurotransmitters and/or other biomarkers. Lifetree’s expertise in sampling CSF allows assay concentrations of the parent compound and metabolites as well as many potential biomarkers in CSF to be examined.

With board-certified anesthesiologists, and supporting staff reflecting a strong nursing/medical pedigree, Lifetree Clinical Research® has unrivaled capabilities in the acquisition of Cerebral Spinal Fluid- single taps, or through 24-48 hr catheterization to facilitate the assay of drug levels, as well as pharmacodynamic or disease related biomarkers. Sample handling, storage, and shipment for analytic purposes can be tailored to the unique requirements of each assay, and are conducted under GCP.

Lifetree’s on-site treatment room provides a spacious sterile environment for these critical study procedures, thereby sparing patients and clients the unnecessary scheduling difficulties of a hospital setting. The treatment room is equipped with fluoroscopy to aid in the guided catheter placement by our qualified Anesthesiologists. During the catherization period and approximately 24 hrs post removal, subjects are required to lie down with limited movement. An example of appropriate activities during this time would include using the restroom and sitting up to eat. This restriction in movement helps to reduce the incidence of spinal headaches and also helps to maintain good catheter placement.

Lifetree's CSF Capabilities

CSF Sampling
  • Highly specialized skill
  • Fluroscopic access
  • Continuous or single tap aspirations
  • Market potential evolving
  • No difficulty with recruitment and IRB to date

Cerebral Spinal Fluid and Drug Development
  • Proof of CNS Bioavailability
  • CSF Pharmacokinetics
  • CSF Biomarker Assays for:
    • Disease modification
    • Pharmacologic effect; neuromodulation
  • PET Imaging and CSF PK/PD relationships
  • Blood/CSF PK/PD relationships