Status:
UNKNOWN
Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
University of Bergen
University Hospital Ulm
Conditions:
Multiple Sclerosis
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
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 patient...
Detailed Description
Prospective, interventional, randomized, placebo-controlled, cross-over study. Patients are randomized to either treatment arm A or B. Patients in both treatment arms receive intrathecal autologous M...
Eligibility Criteria
Inclusion
- 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 - 15 years
- Signed, written informed consent
Exclusion
- 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
- 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
- Current treatment with fampridin
- 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
- 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 within the preceding 12 months
- Contraindications to MRI
- Prior or current major depression
- 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
- History of autologous/allogenic bone marrow transplantation or peripheral blood cell transplant
- 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
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04749667
Start Date
August 9 2021
End Date
January 4 2025
Last Update
September 11 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Akershus university hospital
Lørenskog, Akershus, Norway
2
University hospital of North Norway
Tromsø, Troms Og Finnmark, Norway
3
St.Olav university hospital
Trondheim, Trøndelag, Norway
4
Haukeland University Hospital
Bergen, Vestland, Norway