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Safety
The nature of the stem cells necessitate
ample safety standards. ASC Treatment
has multiple safety standards in place to
mitigate any operational risks.
• Vero Insurance
Each treatment procedure is also insured by Vero
Insurance, one of Australia’s most prominent medical
insurers for up to AUD 20 million. This is also the only
stem cell treatment within Australia to be covered by
a medical insurance policy, reflecting high safety
profile of AMPC. Your peace of mind will be ensured
with our stem cell treatments.
• Non-genetic manipulation culture
The method of stem cell culture does not involve
genetic manipulation that may result in a risk of
mutation that contributes to cancer. No viruses,
antibiotics, growth factors, animal components, or
reagents are added into the culture of the stem cells.
• Regulation-compliant laboratories
All culture processes take place in ASC’s laboratories.
The current facilities include a physical containment
2 laboratory and all protocols are compliant with
Good Tissue Practice (GTP).
• Autologous
The autologous nature of the cells also removes
many risks associated with transplantation of cells
foreign to the body. These cells are sourced from the
recipient’s body that recognises the physiology, and
will thus easily be reintegrated into the system.
• Closed system culture
The collected blood is sealed in the blood bag and all
subsequent processes take place within a closed
system until the day of reinfusion. All tubes and
connections to the blood bag are sealed with high
heat with a Terumo docking station that sterilises the
sealed point. Spiking will also be done to retrieve a
small sample for screening. This process takes place
under a laminar flow cabinet to prevent
contamination.
• NATA screening
To further ensure sample safety, each cultured
sample is screened by a NATA-accredited laboratory
for contamination. The tests screen for total viable
aerobic count, total viable count, microbial growth,
endotoxin, and real-time PCR mycoplasma tests.
These ensure that the live cells are not contaminated.
• Preclinical safety test and safety trials
The product has undergone extensive pre-clinical
testing and is now embarking on safety trials further
verify safety, as per the standards set by the
International Society for Stem Cell Research (ISSCR).
Disclaimer
Although stem cell therapy has been demonstrated to alleviate symptoms of different disorders, it can neither predict nor guarantee the success
of every stem cell therapy procedure. This is due to the nature of all medical interventions where there is an inherent risk attached. A medical
practitioner should be consulted should there be any concerns with partaking in this treatment.
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