Studies of human populations, volunteers and patients

Scanning Technologies

Scanning technologies (e.g. MEG, MRI, PET and CT) have isolated brain abnormalities in some humans providing information about the causes of disease and disorder.

For example studies using magnetoencepahlography (MEG) provide a new understanding of human vision and epilepsy.

Laser Doppler perfusion imaging can be used to directly investigate the circulation of tiny blood vessels of diabetic human volunteers.

Transcranial Magnetic Stimulation (TMS)

Transcranial magnetic stimulation (TMS) has been used to study the function of the human brain in healthy volunteers. For example: A study by Professor V. Walsh and colleagues aimed to learn more about neural processing by safely mimicking brain damage. The technique is now used in place of some experiments on non- human primates. See also: Pascal-Leone, A, Walsh, V & Rothwell, J 2000, 'Transcranial magnetic stimulation in cognitive science', Opinion in Neurobiology 10 (2), pp.232 -237.

Research is currently being conducted into TMS as a possible treatment for psychiatric disorders. See Bersani, FS et al 2013 ‘Deep cranial magnetic stimulation as a treatment for psychiatric disorders’ Eur. Psychiatry 28 (1) pp.30-9; Li, H. et al 2014 ‘Repititive transcranial magnetic stimulation for panic disorders in adults’. The Cochrane data base of systematic reviews. 9.

Research is currently being conducted into TMS as a possible treatment for depression: http://www.blackdoginstitute.org.au/public/depression/treatments/physical.cfm#Transcrania

Repetitive transcranial magnetic stimulation (rTMS) could be a treatment tool for various neurological conditions. Such as:

Stroke: Mansur, C., et al., 2005, A sham-stimulation controlled trial of rTMS of the unaffected hemisphere in stroke patients. Neurology, 64, pp 1802-1804.

Neuropathic pain: Lefaucheur, JP et al 2014, ‘Evidence based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS)’. Clinical Neurophysiology, 125 (11), pp. 2150-2206

Parkinson's disease: Khedr, E., et al.,2006, 'Effects of daily repetitive transcranial magnetic stimulation on motor performance in Parkinson's disease', Movement Disorders, 21:pp 2201-2205.

And possibly Migraine: www.medicalnewstoday.com/articles/148317.php

HUMAN CELLS AND TISSUE

The use of human cells and tissue leftover from surgical procedures, placentas or donated cadavers can be used to produce vaccines, develop drugs, detect toxicity and corrosiveness of chemicals etc. (See In Vitro for more details.)

CLINICAL PATCH TEST

The use of clinical patch test in human volunteers can confirm that a chemical will not cause irritation or allergic skin reaction. The “human 4-hr patch test is a valid alternative to the equivalent rabbit test for the assessment of skin irritation hazard to humans.”

Griffiths, H. A., et al., 1997, 'Interlaboratory evaluation of a human patch test for the identification of skin irritation potential/hazard', Food and Chemical Toxicology 35 (2)](http://www.sciencedirect.com/science/journal/02786915), pp 255-260

POST-MARKETING DRUG SURVEILLANCE

A system that allows consumers to report all effects of a medication after it has been released to the public. It alerts to negative side effects but could also increase the likelihood of finding new uses for existing drugs.

HUMAN MICRODOSING

This technique involves giving minute doses of novel medicines to volunteers. A microdose is too small to be toxic but it allows the pharmakinetics of the active ingredient to be studied. http://www.nc3rs.org.uk/downloaddoc.asp?id=339&page=193&skin=0

Human Microdosing aims to reduce the resources spent on non-viable drugs and reduce the number of animal experiments.

Traditional preclinical studies take up to 18 months and cost US$3-$5 million. Human Microdosing proves its value in drug R & D, 2005. Drug Researcher.com

Microdosing can cut the time spent in early testing down to 4 and 6 months and cut costs by 10 times. European Union Microdose AMS Partnership Programme (EUMAPP) - Background Paper - January 2006.

Microdosing identifies which drugs are unlikely to be successful pre-Phase 1 of the testing process. Combes, R.D., et al. 2003. 'Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing', European Journal of Pharmaceutical Sciences, 19(1), pp. 1-11.

Arora, T et al 2011. ‘Substitute of animals in drug research’ Indian J. Pharm Sci 73(1) pp.1-6.

TISSUE ENGINEERING RATHER THAN XENOTRANSPLANTATION

Tissue engineering has led to the first successfully grown replacement organ. A bladder made from the patient’s own cells. (Atala, A. et al., 2006, 'Tissue-engineered autologous bladders for patients needing cystoplasty', The Lancet, Volume 367, Issue 9518, pp 1241 – 1246.)

  1. Building a Bladder
  2. Bioengineered bladders

“Atala adds that they are also working on growing bio-engineered hearts and pancreases.” http://newscientist.com/article/dn8939-bioengineered-bladders-successful-in-patients.html

For overview see Fodor, W 2003 ‘Tissue engineering and cell based therapies, from the bench to the clinic: The potential to replace, repair and regenerate’. Reprod. Biol. Endocrinol. 1 102.

Others are currently working on Bone Tissue Engineering.

Gene Studies

This area is undergoing rapid development. See for instance:

Australian Genome Research Facility: www.agrf.org.au
Australia's largest genomic services provider with state-of-the-art facilities in Brisbane, Melbourne and Adelaide. Servicing the academic and commercial markets. AGRF provides genomic service solutions across the entire biological spectrum from microbes to plants, animals and humans.

Genetic Repositories Australia: https//www.neura.edu.au/scientific-facility/gra
GRA has been supported by an NHMRC Enabling Facility Grant to establish a central national facility for establishing, distributing and maintaining the long-term secure storage of human genetic samples from a variety of sources. This includes the production and provision of immortalised lymphoblast cell lines and DNA samples. GRA is based at the Prince of Wales Medical Research Institute in Sydney.

Genomics Australia: www.bioplatforms.com.au/platforms/genomics
Consortium of genomics service providers from around Australia. Builds on AGRF. Includes a regional network and a development team focussing on new research tools.

Last reviewed: 19 March, 2019.