Allogeneic umbilical cord tissuederived mesenchymal stem cells in the treatment of multiple sclerosis.

Erna West, CELVI Founder and CEO

Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord. In MS, the immune system attacks the myelin sheath that covers nerve fibres, resulting in communication problems between the brain and the rest of the body. The disease can cause permanent damage or deterioration of the nerves. There is no cure for multiple sclerosis, although treatment may reduce the frequency of exacerbations and slow disease progression while managing symptoms.

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The preliminary results of a landmark trial published in April 2018 confirm that autologous hematopoietic stem cell transplantation for highly active relapsing remitting multiple sclerosis with more than 2 relapses a year, is superior to continued disease modifying drugs, and resulted in a significantly prolonged time to disease progression2. Neil Riordan1 has highlighted that MSCs derived from the umbilical cord have advantages compared to other sources, including high proliferation and expansion ability, enhanced therapeutic activity and superior production of growth factors that stimulate secretions responsible for therapeutic potential.

This open-label, single-arm, single-centre phase I/II study was designed to assess the safety and efficacy of the intravenous administration of umbilical cord mesenchymal stem cells (UCMSCs) for the treatment of MS. Safety is defined as the absence of treatment-associated adverse events at one month, three months, and one-year post treatment. Efficacy is assessed with traditional MS evaluation instruments and a quality of life questionnaire at follow-up intervals. Twenty patients with a mean age of 41 and mean disease duration of 7.7 years were enrolled. Patients received 140 × 106 UCMSC intravenously over the course of seven visits (20 × 106 UCMSC per day) separated by one to four days.

The results have shown that the infusion of UCMSC over several days is safe in MS patients and may have some benefits. In this small study group, improvements were reported in bladder, bowel and sexual dysfunction, walking, upper extremity physical function, energy and fatigue levels, MRI lesions and a general perspective of a positive health change and improved quality of life.

At the one-year point, improvements in disability levels were still present and could translate into the improved ability to walk and work without assistance. The potential durable benefit of UCMSC treatment at one month, and sustained in some measures to one year, is a stark contrast to current MS drug therapies, which need to be taken daily or weekly.

More clinical studies, particularly with a larger cohort, are needed to substantiate the specific benefits of UCMSC infusion as a potential MS therapy.

References:

1.Riordan et al. Clinical feasibility of umbilical cord tissue‑derived mesenchymal stem cells in the treatment of multiple sclerosis. J Transl Med (2018) 16:57 https://doi.org/10.1186/s12967-018-1433-7
2.Burt et al. Effect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression in Patients with Relapsing-Remitting Multiple Sclerosis JAMA. 2019 Jan 15; 321(2): 165–174. doi: 10.1001/jama.2018.18743: 10.1001/jama.2018.18743

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The treating doctor will determine the use of cord blood for treatment, depending on many factors, including the patient’s medical condition, the quality of the cord blood sample, if the patient’s own cord blood can be used or an adequately matched donor’s cord blood.The use of cord blood has been established in stem cell transplantation and has been used to treat more than 80 diseases. The use of cord blood in regenerative medicine is still being researched and there is no guarantee that treatments being studied in the laboratory, clinical trials, or other experimental treatments will be available in the future.The use of cord tissue stem cells is still in early research stages, and there is no guarantee that treatments using cord tissue stem cells will be available in the future. Cord tissue stem cells are found in the cord tissue which is stored whole. Additional processing will be required to isolate the stem cells from the tissue for use. CELVI (Pty) Ltd outsources all cord blood and tissue processing and storage activities to Next Biosciences in Midrand, South Africa, a licensed and AABB accredited facility.

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