Stem Cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS)
This is a randomised, double-blind crossover study to study the effect of intravenous treatment with autologous (derived from the individuals themselves) mesenchymal stem cells (MSCs)in patients with multiple sclerosis (MS).
Current treatments for MS target the immune system and are not curative. There is much interest in MSCs as they have the potential to not only affect the immune system but may also promote repair. This study will use MSCs that are harvested from the bone marrow and grown for up to 52 days before being given back to the person from whom they were harvested. This avoids any chemotherapy so is therefore safer than other types of stem cells. In this crossover study, everyone will receive their own stem cells back but in half it will be delayed by 24 weeks.
The primary outcomes are to check that the procedure is safe and to measure any changes on the MRI at 24 weeks. Other more exploratory measures will try to assess effects on repair in the central nervous system (CNS).
Drug: Mesenchymal stem cells
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Stem Cells in Rapidly Evolving Active Multiple Sclerosis|
- Safety [ Time Frame: Up to 1 year from baseline ] [ Designated as safety issue: Yes ]The number,time-frame and severity of adverse events in the stem cell treatment group will be compared to the placebo group.
- Efficacy [ Time Frame: Up to 1 year from baseline ] [ Designated as safety issue: No ]To evaluate the efficacy of autologous mesenchymal stem cells in MS patients, quantified by the reduction in the number of new contrast-enhancing lesions on MRI scans over 24 weeks and the total number of GEL counted over months 1, 3 and 6 will be compared between treatment groups.
- contrast enhancing lesions identified over months 1, 3 and 6 will be compared between treatment groups. [ Time Frame: Months 1, 3 and 6 ] [ Designated as safety issue: No ]Number of contrast enhancing lesions identified over months 1, 3 and 6 will be compared between treatment groups.
- Comparison of contrast enhancing lesions between treatment periods [ Time Frame: Months 1-12 ] [ Designated as safety issue: No ]The number of contrast enhancing lesions counted over months 7, 9 and 12 (cross-over re-treatment) compared between treatment periods (placebo vs. active treatment) for each patient.
- Combined unique MRI activity [ Time Frame: Months 1-12 ] [ Designated as safety issue: No ]The number of new or enlarging T2, or enhancing or re-enhancing lesions.
- Relapses [ Time Frame: 20 months ] [ Designated as safety issue: No ]number of relapses in MSC treatment group vs. placebo group in the first 6 months and after cross-over re-treatment in the two groups
- Progression of disability [ Time Frame: 36 months ] [ Designated as safety issue: No ]time to sustained progression of disability and proportion of progression-free patients.
- Disease free patients [ Time Frame: 36 months ] [ Designated as safety issue: No ]The proportion of disease-free patients (i.e. patients without relapses) and progression of MRI activity in the two groups.
- MSFC score [ Time Frame: 36 months ] [ Designated as safety issue: No ]the changes in the Multiple Sclerosis Functional Composite (MSFC) score in MSC treatment group compared to the placebo group.
- peripheral immune responses [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Type 4 hypersensitivity reaction [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]The effect of mesenchymal stem cells on delayed type hypersensitivity (Type 4 hypersensitivity reaction) as measured by the Mantoux test
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
|Experimental: mesenchymal stem cells||
Drug: Mesenchymal stem cells
1.0-2.0 million cells/kg body weight
|Sham Comparator: Placebo||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606215
|Contact: David Wilkie, MDemail@example.com|
|Imperial College Healthcare NHS Trust||Recruiting|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Paolo A Muraro, MD PhD||Imperial College London|