Press release issued: 1 June 2011
The University of Bristol and North Bristol NHS Trust have been given a $1.1 million grant by The Kenneth and Claudia Silverman Family Foundation to fund a phase II clinical trial of bone marrow cellular therapy in MS patients.
Bone marrow stem cells have been shown in several experimental laboratory studies to have beneficial effects in disease models of MS. Bone marrow is known to contain stem cells capable of repairing many types of tissue and organ damage - and so is of great interest to those working to develop new treatments for many diseases, including those affecting the nervous system.
The research team, led by Neil Scolding, Burden Professor of Clinical Neurosciences at the University of Bristol and North Bristol NHS Trust, has completed a phase I trial into the safety and feasibility of the therapy to establish what effects, good or bad, bone marrow stem cells have on patients with MS, and their disability. Following encouraging results, the team now plans to conduct a larger phase II trial to test and assess the effectiveness of the therapy.
Professor Scolding said: “MS is the most common disabling neurological condition affecting young adults. Thanks to this generous donation from The Kenneth and Claudia Silverman Family Foundation, we are able to take a major step forward in our research to try and find a treatment for this disease, through this trial which we hope will commence later this year.”
The Bristol team published an online article on the phase I trial last year [May 2010] in Clinical Pharmacology and Therapeutics and a press release was issued on 5 May 2010 about the research paper. The paper, Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis was performed at the University of Bristol’s Institute of Clinical Neurosciences, Frenchay Hospital, Bristol and the Bristol Haematology and Oncology Centre.
Participants had a general anaesthetic during which bone marrow was harvested. The marrow cells were filtered and prepared so that they could be injected into the patient’s vein later the same day.
The procedure was well tolerated and the participants were followed up for a year. No serious adverse effects were encountered. The results of clinical scores were consistent with stable disease. The results of neurophysiological tests raised the possibility of benefit.
Professor Scolding added: “Research into the underlying mechanisms is ongoing and vital, in order to build on these results. We believe that stem cells mobilised from the marrow to the blood are responsible, and that they help improve disease in several ways, including neuroprotection and immune modulation.”
2. Phase I of the study was funded by the Adrian Wright Bequest, The Patrick Berthoud Charitable Trust, The Kenneth and Claudia Silverman Family Foundation, The Myelin Project, the Captain SK Trust and The Burden Trust.
3. Paper: Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis, CM Rice, EA Mallam, AL Whone, P Walsh, DJ Brooks, N Kane, SR Butler, DI Marks and NJ Scolding, Clinical Pharmacology & Therapeutics advance online publication, 5 May 2010 (DOI 10.1038/sj.clpt. 12-09-0672.R2).
4. The Multiple Sclerosis and Stem Cell Research Group is part of the University of Bristol Institute of Clinical Neuroscience and is based at the Burden Centre at Frenchay Hospital. The Group’s activities centre, in particular, on the underlying cell biology of multiple sclerosis, the development and implementation of myelin repair treatments and understanding mechanisms of neurodegeneration.
5. Recruitment for phase II trial will begin at the end of the year.
University of Bristol,
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