Repeat Infusion of Autologous Bone Marrow Cells in Multiple Sclerosis
Repeat Infusion of Autologous Bone Marrow Cells in Multiple Sclerosis (SIAMMS-II)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Infusion of autologous bone marrow
What it measured
Main measures
Adverse events
1 year post-infusion of autologous bone marrow
Safety
Other measures (5)
Global evoked potential
Baseline then 6 months and 12 months post-infusion of autologous bone marrow
Myelin repairMRI brain
Baseline and 6 months post-infusion of autologous bone marrow
MRI lesionsExpanded disability status scale (EDSS)
Baseline then 6 months and 12 months post-infusion of autologous bone marrow
Disability progressionMultiple sclerosis functional composite (MSFC)
Baseline then 6 months and 12 months post-infusion of autologous bone marrow
Disability progressionThinking and memoryWalking and mobilityMultiple sclerosis impact scale (MSIS-29)
Baseline then 6 months and 12 months post-infusion of autologous bone marrow
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 25 to 80
Show the full criteria
Inclusion criteria
Participation in the phase I safety and feasibility 'Study of Intravenous Autologous Marrow in Multiple Sclerosis' (SIAMMS) (REC reference number number 05/Q1704/137 Clin Pharmacol Ther. 2010 Jun;87(6):679-85)
Exclusion criteria
* pregnancy, breastfeeding or lactation * bone marrow insufficiency * history of lymphoproliferative disease or previous total lymphoid irradiation immune deficiency * history of current or recent (\<5 years) malignancy * chronic or frequent drug-resistant bacterial infections or presence of active - infection requiring antimicrobial treatment * frequent and/or serious viral infection * systemic or invasive fungal disease within 2 years of entry to study * significant renal, hepatic, cardiac or respiratory dysfunction * contraindication to anaesthesia * bleeding or clotting diathesis * current or recent (within preceding 12 months) immunomodulatory therapy other than corticosteroid therapy * treatment with corticosteroids within the preceding 3 months * radiation exposure in the past year other than chest / dental x-rays * previous claustrophobia * the presence of any implanted metal or other contraindication to MRI participation in another experimental study or treatment within previous 24 months
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
There is no cure for Multiple Sclerosis (MS) and we are always looking at new ways to stop the disease process and/or promote repair. We hypothesise that autologous bone marrow cellular therapy in chronic MS offers durable benefit. The purpose of this study is to test the safety of repeated bone marrow stem cell infusion in patients with MS. We want to find out what effects, good and/or bad, it has on you and your disability. You have previously participated in a safety study of bone marrow stem cell infusion in patients with MS. The results raised the possibility of some early partial repair; measurements of the speed of neurological impulses in the brain and spinal cord improved. The current study seeks to determine whether those benefits have persisted and whether they can be repeated or enhanced by repeating the procedure.
Papers
Loading reviews and guidelines…
History
Started
Jan 2014
Main results due
Sept 2017
Finished
Aug 2018