MSC-pMS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Rildinadstrocel
What it measured
Main measures
Appearance of adverse events
48 months following first treatment
SafetyThe changes in Expanded Disability Status Scale (EDSS) score 0-10 scale, higher scores show worsening of disability)
48 months
Disability progression
Other measures (4)
Changes in the percentage of CD4/CD25/FoxP3 triple positive stained cells (T regulatory cells), following MSC-treatment
up to 6 months
Immune responseChanges in the percentage of CD3+CD69+ cells (activated lymphocytes), following MSC-treatment
up to 6 months
Immune responseChanges in the percentage of CD11c+/CD86+/Lin- cells (dendritic cells and antigen-presenting macrophages), following MSC-treatment
up to 6 months
Immune responseChanges in the proliferation ability of mononuclear cells to PHA, following MSC-treatment
up to 6 months
Who could take part
Progressive MS · 18 to 65
Inclusion Criteria: 1. Consenting patients fulfilling the Poser's criteria for definite MS 2. Age 18-70 3. Male and female 4. EDSS rate 5.5-7.5 (moderate to high disability) 5. Failure to two lines of the currently available registered immunomodulatory treatments for MS. The lack of response to these treatments was determined by either an increase in EDSS or the appearance of at least two relapses of MS during the year prior to inclusion. Exclusion Criteria: 1. Patients who were treated with cytotoxic medications during the last three months prior to the infusion. 2. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results. 3. Patients with active infections. 4. Patients with cognitive decline or inability to understand and sign the informed consent.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
An open prospective study with multiple (every 6-12 months) intrathecal or intravenous injections of autologous MSC in patients with progressive forms of MS (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery.
Papers
Loading reviews and guidelines…
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History
Started
Jan 2013
Main results due
Dec 2016
Finished
Apr 2020
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