Stem Cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01606215|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2012
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Mesenchymal stem cells Drug: Placebo||Phase 1 Phase 2|
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 of the patients 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Stem Cells in Rapidly Evolving Active Multiple Sclerosis|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: mesenchymal stem cells
1-2 x106 MSCs/kg administered at Week 0
Drug: Mesenchymal stem cells
1.0-2.0 million cells/kg body weight
Other Name: Mesenchymal stromal cells
Sham Comparator: Placebo
Suspension media administered at Week 0
Other Name: Sham
- Frequency, Timing and Severity of Adverse events in MSC and placebo groups as Assessed by CTCAE v4.0 [ Time Frame: Up to 1 year from baseline ]The number,time-frame and severity of adverse events in the stem cell treatment group will be compared to the placebo group.
- Total number of GELs at weeks 4, 12 and 24 after MSC therapy [ Time Frame: Up to 1 year from baseline ]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 ]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 ]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 ]The number of new or enlarging T2, or enhancing or re-enhancing lesions.
- Relapses [ Time Frame: 20 months ]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 ]time to sustained progression of disability and proportion of progression-free patients.
- Disease free patients [ Time Frame: 36 months ]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 ]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 ]changes in immune cell frequencies and serum cytokines after MSCs
- Type 4 hypersensitivity reaction [ Time Frame: 48 weeks ]The effect of mesenchymal stem cells on delayed type hypersensitivity (Type 4 hypersensitivity reaction) as measured by the Mantoux test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606215
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Paolo A Muraro, MD PhD||Imperial College London|