MS-ten Technology

***N.B. MedCell are planning to offer stem cell therapy for the treatment of Achilles tendonopathy once appropriate authorisations have been obtained from the MHRA. Please contact us if you are interested in being considered for this service.***

Technology
Mesenchymal stem cells are found in mature (or adult) tissue. These cells can renew themselves and differentiate into a variety of cell types including the precursors of bone, cartilage, fat, tendon and ligament.

A small colony of mesenchymal stem cells

MedCell's MS-ten technology (developed in conjunction with the RVC and the IOMS) harnesses the plasticity of adult mesenchymal stem cells to promote regeneration of tendon. This provides, for the first time, the potential to regenerate functional tendon tissue where a tendon has been injured. The medical application of the technology is straightforward. The procedure involves the collection of the patient's own bone marrow, followed by isolation and expansion of a mesenchymal stem cell-rich cell population in the laboratory. Cells are re-suspended at a specified concentration and implanted directly into the lesion using ultrasound guidance. Thereafter the patient enters a controlled rehabilitation programme to promote regeneration of the tendon or ligament.

The company's pioneering work has developed, trialled, and clinically utilised autologous mesenchymal stem cells in the treatment of tendon and ligament injuries. To date this clinical use has been carried out in the most testing of arenas, the equine athlete. MedCell is currently making the scientifically rational and straightforward step to develop this technology for human tendon and ligament injuries.

The athletic horse provides an excellent model for human tendon injury; the injuries are patho-mechanically similar, the horse is a large valuable animal, it regularly suffers debilitating tendon overuse injuries, and its level of physical performance is paramount.

Traditional therapies result in a less efficient (scarred) tendon and 'recovered' animals have a high risk of re-injury. Prognosis in the athletic horse is assessed both in terms of return to racing and re-injury rate.

VetCell (MedCell's sister company) has, to date, treated approximately 1000 equine athletes in order to demonstrate proof of principle at the clinical level. Outcome measures in the racehorses treated by VetCell show that around 80% have returned to performance (moderate to severe injuries) with a re-injury rate of 27%.

As demonstrated in the graph below, this compares favourably with published figures for other forms of tendon injury treatment (marked as the control below).

 

A graph showing how VetCell's StemRegen stem cell therapy compares with other treatments for racehorses sustaining tendon injuries.

A diagram showing human Achilles tendonitis and a close up of tendon degeneration

Development

MedCell's MS-ten development plan is split into 3 phases:

The pre-production verification has started (as of August 2010) and will establish standard operating procedures for the culture of mesenchymal stem cells of human bone marrow origin and further develop in-process and release tests and specifications. 

The human pilot study will explore the safety and tolerability of the use of autologous cells to treat Achilles tendonitis. This will be carried out in 24 patients for whom standard treatment has failed to resolve the tendonitis. On the basis of regulatory advice and feedback from specialist orthopaedic surgeons, we anticipate that the pilot study will start in Q3 2011 and have an estimated 12 months follow-up.

The pivotal study is expected to include up to 100 patients with 12 to 18 months follow-up. The forecast projects that the pivotal study will start in Q2 2012 and be completed in Q2 2014.

As an autologous cell therapy, the MS-ten product has the potential to gain regulatory approvals within 4 years. The company plans to fund this technology through to completion of the pilot clinical study. 

***N.B. MedCell are planning to offer stem cell therapy for the treatment of Achilles tendonopathy once appropriate authorisations have been obtained from the MHRA. Please contact us if you are interested in being considered for this service.***