Effects of natural seaweed extract (GFS) on mobilisation of human bone marrow stem cells and immune system activation

A randomised phase II study to evaluate the effects of natural seaweed extract (GFS) in normal volunteers on mobilising stem cells and activating the immune system.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000021673

Enrollment

100

Registered

2005-07-18

Start date

2004-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The aim of this study is to look at the effects of ingesting seaweed fucoidan (GFS) on the mobilisation/release of haematopoeitic progenitor stem cells from bone marrow to the peripheral blood and to study its effects on modulating the immune system. This will be important in treatment following autologous transplantation, AIDS and cancer patients. Investigational Arms: 1. 3g of 10% GFS/Day for 12 days 2. 3g of 75% GFS/Day for 12 days 3. G-CSF treatment

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Volunteers criteria:Healthy adults, non-smokers, no treatment in the last 30 days including contraceptive pills, no history of thyroid abnormalities, no sulpher allergy. Withdrawal criteria:development of thyroid abnormalities, volunteer requestG-CSF subjects:normal adult subjects, suitable for G-CSF treatment, about to recieve G-CSF

Outcome results