A study to evaluate the regenerative effect of mesenchymal stem cell treatment in patients with multiple sclerosis
- Conditions
- Multiple sclerosis (MS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-002373-95-NO
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
•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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method