ACT Refute the Allegations
September 5th 2006
Letter to Patients
re: BBC Newsnight Programme
In this statement ACT say:
We understand that the allegations and hype created by the press is the cause for much concern by recipients of the therapy as well as those intending to have the therapy.
We assure you that the cells used by ACT for therapeutic purposes have been produced and manufactured in accordance and in strict compliance with Good Laboratory Practice, are screened for infectious diseases and are also subjected to the safety and efficacy standards required internationally.
The company has recently completed the 2005 ACT Safety & Efficacy Audit, designed specifically to investigate and determine the safety and efficacy if its treatments.
This clearly proves that, of the 728 subjects treated, an average of more than 70% of neurological subjects received clinical benefit. It also reinforces the fact that patients treated experienced no significant side effects. On the contrary, it displays the extraordinary results the majority of patients treated received.
Please also note the European Union introduced a directive in April 2006 regarding technical requirements for the donation, procurement and testing of human tissues and cells. In principle, ACT was already acting in accordance with this.
The EU directive will govern all future cell lines produced by ACT at two EU contract laboratories with official ‘for human use’ status. Please note that prior to the EU directive it was impossible to generate this status and the ‘for research use’ was the only acceptable status on which a lab could release cells. This term does not stipulate whether that research is laboratory, animal, or human and can easily be misconstrued.
To further ensure levels of safety, ACT’s products are accompanied by a Certificate of Analysis clarifying safety relating to infectious diseases as well as cell type, purity, cell count and bacteriological studies. In addition, the cells have undergone screening by Dr Robert Trossel of the PMC Clinic in Rotterdam to ensure safety and viability.
Furthermore, and in compliance with the evidence-based safety guidelines that aCT has adopted, the cells undergo third party analysis by an independent analysis laboratory which has full Clinical Pathology Accreditation in the UK.
These procedures clearly show ACT’s commitment to product safety and efficacy.
I personally find this statement vague, to the point of being evasive. Think long and hard before spending your life-savings on this unproven therapy. I, certainly, will not be saving up my pocket money for a few years yet.
DISCLAIMER: The content of this site does not represent a qualified medical opinion. It is simply the information amassed by an MS patient while trying to understand this condition. You should seek the advice of your medical practitioner or neurologist before trying any treatment you may read about on this site. I am not a doctor, I am a patient.
