Multiple sclerosis (MS)
Conditions
Interventions
Product Name: Mesenchymal stem cells
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: In
Sponsors
Haukeland University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 to =55, both genders • Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS (1) • An EDSS score of 4 to 7 • Disease duration 2 - 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with cytotoxic medications during the last 3 months prior to inclusion • 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 active or chronic infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as hepatitis B surface antigen positivity and/or hepatitis C PCR positivity verified at screening • 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 • 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 live 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 • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate neuroregenerative efficacy of autologous mesenchymal stem cell treatment in patients with progressive MS as measured by neurophysiological parameters;Secondary Objective: To investigate neuroregenerative efficacy, safety and feasibilty of autologous mesenchymal stem cell treatment in patients with progressive MS as measured by neurophysiological, radiological, ophtalmological and clinical parameters. ;Primary end point(s): •Difference in combined evoked potentials (CEP; visual evoked potentials (VEP) + somatosensoric evoked potentials (SEP) + motor evoked potentials (MEP)) at 6 months (arm A vs. arm B);Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluation of number and nature of adverse events • Difference in CEP at 12 months (study treatment 1 vs. study treatment 2) • Difference in VEP at 6 months (arm A vs. arm B) • Difference in VEP at 12 months (study treatment 1 vs. study treatment 2) • Difference in SEP at 6 months (arm A vs. arm B) • Difference in SEP at 12 months (study treatment 1 vs. study treatment 2) • Difference in MEP at 6 months (arm A vs. arm B) • Difference in MEP at 12 months (study treatment 1 vs. study treatment 2) • Difference in EDSS at 6 months (arm A vs. arm B) • Difference in EDSS at 12 months (study treatment 1 vs. study treatment 2) • Difference in MRI T2-weighted hyperintense lesion volume at 6 months (arm A vs. arm B) • Difference in MRI T2-weighted hyperintense lesion volume at 12 months (study treatment 1 vs. study treatment 2) • Difference in MRI T1-weighted hypointense lesion volume at 6 months (arm A vs. arm B) • Difference in MRI T1-weighted hypointense lesion volume at 6 months (study treatment 1 vs. study treatment 2) • Difference in visual function (visual acuity, visual field, color vision and contrast sensitivity) at 6 months (arm A vs. arm B) • Difference in visual function (visual acuity, visual field, color vision and contrast sensitivity) at 12 months (study treatment 1 vs. study treatment 2) • Difference in retinal thickness measured with OCT at 6 months (arm A vs. arm B) • Difference in retinal thickness measured with OCT at 12 months (study treatment 1 vs study treatment 2) • Difference in brain volume at 6 months (arm A vs. arm B) • Difference in brain volume at 6 months (study treatment 1 vs. study treatment 2) • Difference in Nine-Hole-Peg Test (9-HPT) score at 6 months (arm A vs. arm B) • Difference in Nine-Hole-Peg Test (9-HPT) score at 6 months (study treatment 1 vs. study treatment 2) • Difference in Timed 25 Foot Walk (T25FW) score at 6 months (arm A vs. arm B) • Difference in Timed 25 Foot Walk (T25FW) score at 6 months (stu | — |
Countries
Norway
Contacts
Public ContactDepartment of Neurology
Haukeland University Hospital
Outcome results
None listed