SMART-MS
EU CTIS ID: 2023-510228-63-00
What this study is testing
The primary objective of the study is to investigate neuroregenerative efficacy (proof of concept) of intrathecal treatment with autologous MSCs as measured by neurophysiological parameters in patients with progressive MS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 to ≤55, both genders
- Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS
- An EDSS score of 4 to 7
- Disease duration 2 - 18 years
- Signed, written informed consent
You likely can't join if
- Treatment with cytotoxic medications during the last 3 months prior to inclusion
- History of malignancy, other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year within the last 10 years
- Severely limited life expectancy by another co-morbid illness
- History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts
- Immunocompromised patients
- Estimated glomerular filtration rate <60 ml/min/1.73 m2 or known renal failure
See the full eligibility criteria
- Age ≥18 to ≤55, both genders
- Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS
- An EDSS score of 4 to 7
- Disease duration 2 - 18 years
- Signed, written informed consent
- Treatment with cytotoxic medications during the last 3 months prior to inclusion
- History of malignancy, other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year within the last 10 years
- Severely limited life expectancy by another co-morbid illness
- History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts
- Immunocompromised patients
- Estimated glomerular filtration rate <60 ml/min/1.73 m2 or known renal failure
- Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment
- Platelet (thrombocyte) count <100 x 10*9/L
- Participation in another experimental clinical study with administration of another IMP within the preceding 12 months
- Contraindications to MRI
- Prior or current major depression
- Any illness or prior/ongoing treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate autologous stem cell treatment
- Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.
- Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation
- Known hypersensitivity against paracetamol, codein or xylocain
- Diagnosis or strong suspicion of polyneuropathy
- Prior or current alcohol or drug dependencies
- Inability to give informed consent
- Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as heaptitis B surface antigen positivity and/or hepatitis C PCR positivity
- Current immunomodulatory/immunosuppressive treatment
- Immunomodulatory/immunosuppressive treatment within 6 months prior to inclusion. This includes, but is not restricted to treatment with natalizumab, fingolimod, dimetylfumurat, glatiramer acetate, interferon beta medications, teriflunomide, and siponimod.
- Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion
- Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion
- Treatment with glucocorticoids or ACTH within three months prior to start of inclusion
- Having experienced an MS relapse within 2 years prior to study inclusion
The study team makes the final eligibility decision.
Where it's taking place
- Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.