Magellan believes that stem cell based therapies can significantly contribute to the improvement in treatment of a number of conditions - and in particular musculo-skeletal conditions such as osteoarthritis.
Magellan's current commercial stem cell treatments are based upon the use of adult mesenchymal stem cells. The stem cells are sourced from adipose tissue (‘fat’). The adipose tissue is normally obtained from each patient via a small ‘mini’ liposuction procedure.
In very general terms, there are two types of stem cell treatments – treatments based on using stem cells obtained from each individual patient (autologous treatments) and stem cell treatments based on the use of stem cells from a donor (allogeneic stem cell treatments).
Magellan currently provides autologous stem cell services to doctors treating patients with musculo-skeletal conditions (such as osteoarthritis) – as well as the provision of stem cells as an adjunct therapy for the treatment of spinal disc conditions.
From a regulatory point of view, Magellan is currently only able to supply autologous stem cell treatments – ie treatments that are based on the use of a patient’s own stem cells.
Magellan is currently conducting clinical trials based on the use of allogeneic stem cells (or ‘donor’ stem cells) with the aim of seeking regulatory approval to be able to offer ‘off the shelf’ donor stem cell treatments.
Autologous Stem Cells
From a regulatory point of view - in Australia - Magellan is only permitted to supply stem cells for treatments that are based upon using a patients ‘own cells’ Treatments based upon using a patient’s ‘own cells’ are called autologous treatments. Autologous stem cell treatments first require that a small amount of ‘fat’ is first sourced/removed from the patient in order to ‘obtain cells’. This fat/tissue is normally obtained via a small lipo-suction procedure. Magellan stem cell treatments are based upon Magellan firstly isolating the stem cells from the ‘fat/tissue, and then culturing (expanding) the stem cells such as to be able to supply large therapeutic doses of expanded stem cells to clinicians.
Allogeneic (‘Donor’) Stem Cells
Magellan is currently sponsoring clinical trials with the aim of seeking regulatory approval for the supply of ‘off the shelf’ stem cell treatments - using ‘donor stem cells’ - for the treatment of osteoarthritis.
Allogeneic procedures (using ‘donor cells’), which allow for ‘off the shelf’ stem cell treatments, have three primary advantages:-
1) Patients can be treated with especially selected ‘optimum’ stem cells re the treatment of a particular medical condition,
2) Patients do not have to undergo a surgical (lipo-suction) procedure to obtain tissue/cells.
3) Lower cost - the stem cells can be cultured/expanded in large volumes (rather than on a ‘one by one’ basis - as with autologous procedures - using each patient’s own cells).
Stem Cell Procedures
Magellan Stem Cells operate a clean room laboratory facility in Melbourne, Australia. Isolation and expansion of a `pure’ stem population are undertaken using internationally accepted techniques. All cells are characterized by Flow Cytometry (FACS) using standards set by the International Society for Cellular Therapy. At critical processing points the cell sample undergoes sterility testing using an independent pathology provider. Stem cells are stored for future use in sterile cyrovials using validated methods.
Isolation and Expansion
These autologous treatments require that a small amount of adipose tissue (‘fat’) is first sourced/removed from the patient in order to ‘obtain cells’. This fat/tissue is normally obtained via a small lipo-suction procedure. Following the lipo-suction, the cells in the adipose tissue (stromal vascular fraction – ‘SVF’) are first isolated from the adipose/fat using a GMP grade reagent. This process typically takes 3-4 hours. The isolated stem cells are then separated/purified from all of the other cells in the SVF. This process typically takes 6-10 days. (PS - only about 5% - 10% of the SVF are ‘isolated’ stem cells.).
The isolated stem cells are then expanded (increased in number) such as to provide the required number of stem cells for the treatment(s). The cells are isolated, purified and expanded using strict laboratory protocols that have been designed to ensure optimal processing and adherence to strict standards re sterility etc. All cells are independently tested for bacterial and fungal infections prior to release for the treatment of patients.