Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) for Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Autologous Hematopoietic Stem Cell
- Carmustine
DNA inhibitor|Glutathione reductase inhibitor|RNA inhibitor
What it measured
Main measures
Safety: Adverse Events
12 months
Safety
Other measures (2)
Efficacy: EDSS Score
1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion
Disability progressionEfficacy: RAND-36 Score
1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion
Quality of life (reported by participants)
Who could take part
Progressive MS · 18 to 60
Inclusion Criteria: * Diagnosed with progressive multiple sclerosis with or without relapses * EDSS score between 1.5 and 7.0, including documented rapid progression over the previous year unresponsive to conventional therapies or no available treatment options * Aged between 18 and 60 with a history of at least one enhancing lesion on brain MRI * With absolute neutrophil count ≥ 1,000/mm\^3, platelet count ≥ 100,000/mm\^3 and hemoglobin ≥ 9.0 g/dL Exclusion Criteria: * Patients with cardiac, renal, pulmonary, hepatic, or other organ impairment that would limit their ability to receive dose-intensive immunosuppressive therapy, high-dose chemotherapy, and/or Autologous HSCT * Patients with any active or chronic infection e.g. uncontrolled viral, fungal, or bacterial infection * Uncontrolled diabetes * Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C * Patients whose life expectancy is severely limited by another illness * Patients with evidence of myelodysplasia or other non-autoimmune cytopenia * Patients having received a cytotoxic agent within one month prior to this study * Patients who are pregnant or at risk of pregnancy, including those unwilling to practice * Patients with psychiatric illness, mental deficiency, or cognitive dysfunction * Patients unable to give written informed consent in accordance with research ethics board guidelines
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months, 6 months and 12 months post-transplantation.
Papers
Background
Akkok CA, Liseth K, Hervig T, Ryningen A, Bruserud O, Ersvaer E. Use of different DMSO concentrations for cryopreservation of autologous peripheral blood stem cell grafts does not have any major impact on levels of leukocyte- and platelet-derived soluble mediators. Cytotherapy. 2009;11(6):749-60. doi: 10.3109/14653240902980443.Background
Appelbaum FR, Bacigalupo A, Soiffer R. Anti-T cell antibodies as part of the preparative regimen in hematopoietic cell transplantation--a debate. Biol Blood Marrow Transplant. 2012 Jan;18(1 Suppl):S111-5. doi: 10.1016/j.bbmt.2011.11.002. No abstract available.Background
Burt RK, Balabanov R, Han X, Sharrack B, Morgan A, Quigley K, Yaung K, Helenowski IB, Jovanovic B, Spahovic D, Arnautovic I, Lee DC, Benefield BC, Futterer S, Oliveira MC, Burman J. Association of nonmyeloablative hematopoietic stem cell transplantation with neurological disability in patients with relapsing-remitting multiple sclerosis. JAMA. 2015 Jan 20;313(3):275-84. doi: 10.1001/jama.2014.1798Background
Burt RK, Loh Y, Cohen B, Stefoski D, Balabanov R, Katsamakis G, Oyama Y, Russell EJ, Stern J, Muraro P, Rose J, Testori A, Bucha J, Jovanovic B, Milanetti F, Storek J, Voltarelli JC, Burns WH. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009 Mar;8(3):244-53. doi: 10.1016/S1474-4422(09)70017-1. EpuBackground
Bruck W. The pathology of multiple sclerosis is the result of focal inflammatory demyelination with axonal damage. J Neurol. 2005 Nov;252 Suppl 5:v3-9. doi: 10.1007/s00415-005-5002-7.Background
von Budingen HC, Kuo TC, Sirota M, van Belle CJ, Apeltsin L, Glanville J, Cree BA, Gourraud PA, Schwartzburg A, Huerta G, Telman D, Sundar PD, Casey T, Cox DR, Hauser SL. B cell exchange across the blood-brain barrier in multiple sclerosis. J Clin Invest. 2012 Dec;122(12):4533-43. doi: 10.1172/JCI63842. Epub 2012 Nov 19.Background
Cabezudo E, Dalmases C, Ruz M, Sanchez JA, Torrico C, Sola C, Querol S, Garcia J. Leukapheresis components may be cryopreserved at high cell concentrations without additional loss of HPC function. Transfusion. 2000 Oct;40(10):1223-7. doi: 10.1046/j.1537-2995.2000.40101223.x.Background
Costantino CM, Baecher-Allan C, Hafler DA. Multiple sclerosis and regulatory T cells. J Clin Immunol. 2008 Nov;28(6):697-706. doi: 10.1007/s10875-008-9236-x. Epub 2008 Sep 2.Background
De Boer F, Drager AM, Van der Wall E, Pinedo HM, Schuurhuis GJ. Changes in L-selectin expression on CD34-positive cells upon cryopreservation of peripheral blood stem cell transplants. Bone Marrow Transplant. 1998 Dec;22(11):1103-10. doi: 10.1038/sj.bmt.1701495.Background
Farge D, Labopin M, Tyndall A, Fassas A, Mancardi GL, Van Laar J, Ouyang J, Kozak T, Moore J, Kotter I, Chesnel V, Marmont A, Gratwohl A, Saccardi R. Autologous hematopoietic stem cell transplantation for autoimmune diseases: an observational study on 12 years' experience from the European Group for Blood and Marrow Transplantation Working Party on Autoimmune Diseases. Haematologica. 2010 Feb;95(2
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History
Started
May 2015
Main results due
May 2020
Finished
May 2022
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