NCT01932593: SIAMMS-II

Repeat Infusion of Autologous Bone Marrow Cells in Multiple Sclerosis

Completed NA Last updated 23 August 2018

What this trial tests

NA trial testing Infusion of autologous bone marrow in Multiple Sclerosis in 4 participants. Completed in 20 August 2018.

Timeline

31 January 2014

Primary endpoint
1 September 2017

20 August 2018

Quick facts

Lead sponsor	North Bristol NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	31 January 2014
Primary completion	1 September 2017
Estimated completion	20 August 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Infusion of autologous bone marrow

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

North Bristol NHS Trust — full company profile →

Who can join

Adults 25 to 80, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Paving the way towards an effective treatment for multiple sclerosis: advances in cell therapy.
   Mansilla MJ, Presas-Rodríguez S, Teniente-Serra A, González-Larreategui I, et al · · 2021 · cited 41× · PMID 33958746 · DOI 10.1038/s41423-020-00618-z
2. Reduced cellularity of bone marrow in multiple sclerosis with decreased MSC expansion potential and premature ageing in vitro.
   Redondo J, Sarkar P, Kemp K, Virgo PF, et al · · 2018 · cited 40× · PMID 28548004 · DOI 10.1177/1352458517711276
3. Reduced neuroprotective potential of the mesenchymal stromal cell secretome with ex vivo expansion, age and progressive multiple sclerosis.
   Sarkar P, Redondo J, Kemp K, Ginty M, et al · · 2018 · cited 33× · PMID 28917625 · DOI 10.1016/j.jcyt.2017.08.007
4. The Potential of Stem Cell Therapy to Repair White Matter Injury in Preterm Infants: Lessons Learned From Experimental Models.
   Vaes JEG, Vink MA, de Theije CGM, Hoebeek FE, et al · · 2019 · cited 31× · PMID 31143126 · DOI 10.3389/fphys.2019.00540
5. Safety and efficacy of stem cell therapy for treatment of neural damage in patients with multiple sclerosis.
   Jafarzadeh Bejargafshe M, Hedayati M, Zahabiasli S, Tahmasbpour E, et al · · 2019 · cited 20× · PMID 32039266 · DOI 10.21037/sci.2019.10.06
6. Neural Cells for Neurodegenerative Diseases in Clinical Trials.
   Fan Y, Goh ELK, Chan JKY. · · 2023 · cited 17× · PMID 37487111 · DOI 10.1093/stcltm/szad041
7. Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II).
   Rice CM, Marks DI, Walsh P, Kane NM, et al · · 2015 · cited 12× · PMID 26363342 · DOI 10.1136/bmjopen-2015-009090
8. Made to Measure: Patient-Tailored Treatment of Multiple Sclerosis Using Cell-Based Therapies.
   Wens I, Janssens I, Derdelinckx J, Meena M, et al · · 2021 · cited 9× · PMID 34299154 · DOI 10.3390/ijms22147536