Licences and Manufacturing
LifePlus Stem Cells for non-homologous use fully comply with the relevant UK regulations for the manufacture and delivery of a unlicensed medicinal product. Starting material (adipose tissue or cord tissue) is collected under a HTA licence and manufactured in a licenced GMP facility under the strict guidelines of the Medicines and Healthcare Products Regulatory Agency (MHRA).
The Human Tissue Authority (HTA) Licence
The Human Tissue Authority (HTA) ensures that procurement, testing, processing, distribution and export of tissue and cells for human application is performed in accordance with the quality and safety standards of The Human Tissue Act 2004 and associated regulation/The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended. LifePlus Stem Cells are licenced by the HTA for the procurement and testing of adipose tissue.
Autologous: Patients adipose tissues are harvested under LifePlus Stem Cells Human Tissue Authority (HTA) licenced procurement procedure.
All performed in a CQC registered hospital and manufactured under a The Medicines and Healthcare products Regulatory Agency (MHRA) licenced GMP cleanroom facility at the Centre for Cell Gene & Tissue Therapeutics, Royal Free NHS Foundation Trust Hospital, London.
Patients certified stem cells are then returned to their prescribing doctor or banked for future treatments. Patient processes and records are kept for 30 years in line with HTA regulations.
Medicines and Healthcare Products Regulatory Agency (MHRA) Licence
The manufacturing step to obtain adipose-derived stem cells and returning them to a patient for medicinal purposes falls under the Medicines and Healthcare Products Regulatory Agency (MHRA). To make human medicines, providers require a manufacturer licence, issued by the MHRA.
To qualify for a manufacturer licence providers need to demonstrate to the MHRA compliance with good manufacturing practice ( GMP ) and pass regular GMP inspections – Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017
At LifePlus, Patient’s stem cells are multiplied to concentrations not achieved by any other clinic in the UK (approx. 20millions stem cells are harvested from a 20ml extraction of adipose tissue). Returned stem cells are sterile and infection-risk-free, surplus Stem Cell doses can be banked for future use.
LifePlus clinics are licenced to sell and market pure stem cells products as an unlicensed medicine in accordance with quality and safety standards under its own HTA and MHRA licences (The Human Tissue Act 2004 and associated regulation/The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
There are many clinical situations when the use of unlicensed medicines or use of medicines outside the terms of the licence (ie, ‘off-label’) may be judged by the prescriber to be in the best interest of the patient on the basis of the available evidence, for example the patient is under age for a particular medication. In terms of regenerative medicine the patient may not be suitable for surgery and is no longer responding to steroid injections, in this case the prescriber may prescribe a stem cell treatment.
This medicine is then prescribed as an unlicensed product that has been produced under special manufacturing licences
Who has responsibility for unlicensed medicines?
Prescribers are professionally accountable for prescribing all medicines including unlicensed medicines. It is the prescriber’s responsibility to decide whether their patient has special medical needs, which a licensed product cannot meet.
The Medicines Act allows appropriate prescribers to prescribe medicines without a licence providing they are happy to assume full liability for the prescription.