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.
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.
| Original language | English |
|---|---|
| Article number | 103782 |
| Journal | Multiple Sclerosis and Related Disorders |
| Volume | 61 |
| Early online date | 31 Mar 2022 |
| DOIs | |
| Publication status | Published - 1 May 2022 |
Bibliographical note
Funding Information:Funding for the clinical study was provided by The Sir Halley Stewart Trust. CMR and PS were supported by the Burden Neurological Institute.
Funding Information:
The authors gratefully acknowledge the participants and the staff of both Bristol Haematology and Oncology Centre and NHS Blood and Transplant, Filton, Bristol.
Publisher Copyright:
© 2022 Elsevier B.V.
Keywords
- Progressive multiple sclerosis
- Bone marrow
- Cell therapy