Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
What it found
We found no results in the registry or in papers.
This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Autologous mesenchymal stem cells
What it measured
Main measures
To evaluate number of participants with an adverse event related to the treatment.
48 weeks
SafetyTo evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.
48 weeks
MRI lesions
Other measures (2)
To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).
48 weeks
Disability progressionTo evaluate effect on peripheral blood immune cell populations.
24 weeks
Immune response
Who could take part
Relapsing and progressive · 18 to 65
Inclusion Criteria: 1. Diagnosis of MS 1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months. 2. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year. 3. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year. 2. Age_ 18-65 years 3. Disease duration: 2-20 years 4. EDSS 3,0-7,0 Exclusion Criteria: 1. Subtype of MS not fulfilling inclusion criteria 2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization 3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization 4. Treatment with corticosteroids within the 30 days prior to randomization 5. Relapse occurred during the 60 days prior to randomization 6. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year 7. Severely limited life expectancy by another co-morbid illness 8. Active or chronic severe infection. 9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts 10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study) 11. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination. 12. Inability to give written informed consent in accordance with research ethics board guidelines
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.
Papers
Loading reviews and guidelines…
Related trials
- A Study on the Safety and Tolerability of Universal STAR-…
Phase 1 · Not yet recruiting
Still running
- MB-CART2019.1 in Refractory Multiple Sclerosis
Phase 1 / Phase 2 · Recruiting
Still running
- This is an Early Exploratory Study to Assess the Tolerabi…
Early phase 1 · Recruiting
Still running
- This is an Open-Label Study to Assess the Safety and Effi…
Early phase 1 · Withdrawn
Stopped early
- CD19/BCMA-Targeted UCAR-T for Patients With Neurological …
Early phase 1 · Recruiting
Still running
- A Study to Evaluate the Safety, Tolerability, Efficacy, a…
Phase 1 · Running, not recruiting
Still running
History
Started
Dec 2012
Main results due
Dec 2016
Finished
Dec 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error