Mesenchymal Stem Cells for Multiple Sclerosis
Phase 1/2 Clinical Trial With Autologous Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Autologous mesenchymal stem cells
What it measured
Main measures
To assess the safety of IV therapy with autologous Mesenchymal Stem Cells (MSCs) in MS patients.
48 weeks
MRI lesionsSafety
Other measures (1)
To gather preliminary information of the efficacy of the experimental treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and disability progression).
48 weeks
Disability progressionRelapsesMRI lesions
Who could take part
Relapsing and progressive · 18 to 50
Show the full criteria
Inclusion criteria
1. Diagnosis of MS a. Relapsing remitting MS (RRMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by one or more of the following: i. ≥1 clinically documented relapse in past 12 months ii. ≥2 clinically documented relapses in last 24 months iii. ≥1 GEL at MRI performed within the last 12 months b. Secondary progressive MS (SPMS) not responding to at least a year of attempted therapy with one or more of the approved therapies (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, fingolimod) as evidenced by both: i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥ 5.5) in the last 12 months ii. ≥1 clinically documented relapse or ≥ 1 GEL at MRI within the last twelve months. c. Primary progressive MS (PPMS) patients with all the following features: i. an increase of ≥1 EDSS point (if at randomization EDSS ≤ 5.0) or 0.5 EDSS point (if at randomization EDSS ≥5.5), in the last twelve months ii. ≥ 1 GEL at MRI performed within the last 12 months iii. positive cerebrospinal fluid (CSF) (oligoclonal banding) 2. Age 18 to 50 years 3. Disease duration 2 to 10 years (included) 4. EDSS 3.0 to 6.5
Exclusion criteria
1. RRMS not fulfilling inclusion criteria 2. SPMS not fulfilling inclusion criteria 3. PPMS not fulfilling inclusion criteria 4. Any active or chronic infection including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C 5. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization 6. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization 7. Treatment with corticosteroids within the 30 days prior to randomization 8. Relapse occurred during the 60 days prior to randomization 9. 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 10. Severely limited life expectancy by another co-morbid illness 11. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts 12. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study) 13. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination. 14. 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
The aim of the study is to evaluate the safety and efficacy of autologous mesenchymal stromal cells as treatment for Multiple Sclerosis.
Papers
Loading reviews and guidelines…
Related trials
- A Study on the Safety and Tolerability of Universal STAR-T Cell Therap
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 Tolerability and Safe
Early phase 1 · Recruiting
Still running
- This is an Open-Label Study to Assess the Safety and Efficacy of GC012
Early phase 1 · Withdrawn
Stopped
- CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Di
Early phase 1 · Recruiting
Still running
- A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Level
Phase 1 · Running, not recruiting
Still running
History
Started
Feb 2013
Main results due
May 2019
Finished
Nov 2021