Repeat Infusion of Autologous Bone Marrow Cells in Multiple Sclerosis

NCT01932593 | Completed

• 1 other identifier: SIAMMS-II
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; bone marrow; stem cell therapy

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Number of adverse events

  1 year post-infusion of autologous bone marrow

Secondary Outcomes (5)

• Global evoked potential

  Baseline then 6 months and 12 months post-infusion of autologous bone marrow

• MRI brain

  Baseline and 6 months post-infusion of autologous bone marrow

• Expanded disability status scale (EDSS)

  Baseline then 6 months and 12 months post-infusion of autologous bone marrow

• Multiple sclerosis functional composite (MSFC)

  Baseline then 6 months and 12 months post-infusion of autologous bone marrow

• Multiple sclerosis impact scale (MSIS-29)

  Baseline then 6 months and 12 months post-infusion of autologous bone marrow

Other Outcomes (1)

• Tolerability

  Ongoing post-infusion of autologous bone marrow with a formal request for feedback at 12 months

Study Arms (2)

Infusion of autologous bone marrow

EXPERIMENTAL

Bone marrow harvest under general anaesthetic and intravenous infusion of filtered but otherwise unselected autologous bone marrow

Procedure: Infusion of autologous bone marrow

Placebo

PLACEBO COMPARATOR

Procedure: Infusion of autologous bone marrow

Interventions

Infusion of autologous bone marrow PROCEDURE

Bone marrow harvest under general anaesthetic and intravenous infusion of filtered but otherwise unselected autologous bone marrow

Infusion of autologous bone marrow; Placebo

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• North Bristol NHS Trust: lead
• Sir Halley Stewart Trust: collaborator

Study Sites (1)

North Bristol NHS Trust

Bristol, Avon, BS10 5NB, United Kingdom

Location

Related Publications (1)

• Rice CM, Marks DI, Walsh P, Kane NM, Guttridge MG, Redondo J, Sarkar P, Owen D, Wilkins A, Scolding NJ. Repeat infusion of autologous bone marrow cells in multiple sclerosis: protocol for a phase I extension study (SIAMMS-II). BMJ Open. 2015 Sep 11;5(9):e009090. doi: 10.1136/bmjopen-2015-009090.

  PMID: 26363342 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Neil J Scolding, PhD FRCP

  North Bristol NHS Trust and University of Bristol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: autologous bone marrow cells

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 30, 2013
• Study Start: January 31, 2014
• Primary Completion: September 1, 2017
• Study Completion: August 20, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

GB (1)