Clinical trial for Multiple Sclerosis
Official title Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT06592703
What this study is testing
What is Adipose tissue-derived Mesenchymal Stromal Cells?
This is an investigational treatment being studied as a potential therapy for Primary Progressive Multiple Sclerosis. is designed to be injected into the spinal fluid to potentially help manage the disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if repeated intrathecal (spinal) injections of allogenic adipose‑derived mesenchymal stromal cells are safe and show any sign of benefit.
- Who it's for
- Adults diagnosed with primary progressive multiple sclerosis.
- What's involved
- Participants will receive several intrathecal injections of donor‑derived stem cells and undergo safety monitoring visits and tests.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Patient with Primary Progressive MS according to the criteria of Mc Donald 2017 (Thompson et al Lancet neurol, 2017)
- Age between 18 and 55 years
- EDSS score: 3 to 6 at inclusion
- Documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit
- Positive CSF with oligoclonal bands
You likely can't join if
- Inflammatory activity during the past year (relapses or new T2 MRI lesions)
- Disease Modifying Drugs during the past year
- Treatment with high dose corticosteroids during the 30 days preceding the inclusion
- Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (\<50 G/L)...
- Participation in another therapeutic trial in the last 6 months
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women...
See the full eligibility criteria
- Patient with Primary Progressive MS according to the criteria of Mc Donald 2017 (Thompson et al Lancet neurol, 2017)
- Age between 18 and 55 years
- EDSS score: 3 to 6 at inclusion
- Documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit
- Positive CSF with oligoclonal bands
- For women of childbearing potential (WOCBP), effective contraception as per the CFTG recommendations (version 1.1)
- Having signed a free, informed and written consent
- Affiliated to social security scheme
- Inflammatory activity during the past year (relapses or new T2 MRI lesions)
- Disease Modifying Drugs during the past year
- Treatment with high dose corticosteroids during the 30 days preceding the inclusion
- Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (\<50 G/L), anticoagulant or fibrinolytic treatment
- Participation in another therapeutic trial in the last 6 months
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to express their consent
The study team makes the final eligibility decision.
Where it is enrolling
- Rennes, France
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 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rennes, France. Enter your location above to see the nearest enrolling 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 ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.