Repeat infusion of autologous bone marrow cells in progressive multiple sclerosis - A phase I extension study (SIAMMS II)

Claire M Rice; Pamela Sarkar; Peter Walsh; Denise Owen; Clare Bidgood; Paul Smith; Nick M Kane; Suhail Asghar; David I Marks; Neil J Scolding

doi:10.1016/j.msard.2022.103782

Repeat infusion of autologous bone marrow cells in progressive multiple sclerosis - A phase I extension study (SIAMMS II)

Mult Scler Relat Disord. 2022 May:61:103782. doi: 10.1016/j.msard.2022.103782. Epub 2022 Mar 31.

Authors

Claire M Rice¹, Pamela Sarkar², Peter Walsh³, Denise Owen⁴, Clare Bidgood⁵, Paul Smith⁶, Nick M Kane³, Suhail Asghar⁷, David I Marks⁸, Neil J Scolding⁹

Affiliations

¹ Clinical Neuroscience, Bristol Medical School, University of Bristol, Level 1 Learning and Research Building, Southmead Hospital, Bristol, BS10 5NBww, UK; Department of Neurology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: [email protected].
² Clinical Neuroscience, Bristol Medical School, University of Bristol, Level 1 Learning and Research Building, Southmead Hospital, Bristol, BS10 5NBww, UK; Department of Neurology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
³ Department of Neurophysiology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
⁴ Department of Neurology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
⁵ Adult BMT Unit, Bristol Royal Hospital for Children, University Hospitals Bristol and Weston NHS Foundation Trust, St Michael's Hill, Bristol BS2 8BJ, UK.
⁶ Department of Neuroradiology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
⁷ NHS Blood and Transplant, North Bristol Park, Filton, Bristol, UK.
⁸ Clinical Neuroscience, Bristol Medical School, University of Bristol, Level 1 Learning and Research Building, Southmead Hospital, Bristol, BS10 5NBww, UK; Adult BMT Unit, Bristol Royal Hospital for Children, University Hospitals Bristol and Weston NHS Foundation Trust, St Michael's Hill, Bristol BS2 8BJ, UK.
⁹ Clinical Neuroscience, Bristol Medical School, University of Bristol, Level 1 Learning and Research Building, Southmead Hospital, Bristol, BS10 5NBww, UK.

PMID: 35397289
DOI: 10.1016/j.msard.2022.103782

Abstract

Background: During the safety and feasibility 'Study of Intravenous Autologous Marrow in Multiple Sclerosis (SIAMMS)', intravenous infusion of autologous marrow was well tolerated. The efficacy of the approach is being explored in a placebo-controlled randomised controlled trial (ACTiMuS, NCT01815632) but it is not known whether repeated infusions will be required to optimise benefit. The objective of the current study was to explore the safety and feasibility of repeat treatment with intravenous autologous bone marrow for patients with progressive multiple sclerosis (MS).

Methods: 'SIAMMS II' was a prospective, single centre phase I extension study in which participants in the SIAMMS study were offered repeat bone marrow harvest and infusion of autologous, unfractionated bone marrow as a day-case procedure. The primary outcome measure was number of adverse events and secondary outcome measures included change in clinical rating scales of disability, global evoked potential and cranial magnetic resonance imaging (MRI).

Results: In total, 4 of the 6 participants in the SIAMMS study had repeat bone marrow harvest and infusion of filtered autologous marrow as a day case procedure which was well tolerated. There were no serious adverse effects. Additional outcome measures including clinical scales, global evoked potentials and cranial MRI were stable.

Conclusion: SIAMMS II demonstrates the safety and feasibility of repeated, non-myeloablative autologous bone marrow-derived cell therapy in progressive MS.

Keywords: Bone marrow; Cell therapy; Progressive multiple sclerosis.

Publication types

Randomized Controlled Trial

MeSH terms

Bone Marrow Cells
Humans
Multiple Sclerosis* / drug therapy
Multiple Sclerosis, Chronic Progressive* / drug therapy
Prospective Studies
Transplantation, Autologous
Treatment Outcome