Idiopathic inflammatory demyelinating diseases (multiple sclerosis, neuromyelitis optica))
Conditions
Interventions
AHSCT group:autologous peripheral hematopoietic stem cell transplantation (CD34+)
Control group:The most effective drugs treatment for individuals of the time
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Based on the proposed guidelines for autologous blood and marrow stem cell transplantation in multiple sclerosis and McDonalds criteria for MS, also Wingerchuks criteria for NMOSD. Our inclusive criteria: 1) Aged 18-50 years (not AHSCT age); MS subtypes of RRMS or SPMS; NMOSD; 2) multiple early relapses; 3) MRI found active lesions; 4) EDSS > 3.0 points; 5) Failure of disease-modifying therapies, defined as 2 or more clinical relapses during =6 months of therapy that were associated with an increase in the EDSS score (by 1.0 for prerelapse EDSS score of 5.5 or less, by 0.5 for an EDSS score more than 5.5); Or annual relapse rate (ARR) is more than 3 times or more; 6) Patient data were evaluated by an MS review panel composed of 2 neurologists and a transplant physician; 7) To obtain all the written informed consent from all participants.
Exclusion criteria
Exclusion criteria: 1) patients with severe heart, kidney, lung or liver dysfunction, or patients with active infections or other medical problems that may increase morbidity or mortality; patients with any active or chronic infection, or HIV, or hepatitis B and C surface antigen seropositive patients, or a previous history of a malignancy, or life expectancy is affected by another comorbidity, myelodysplastic or other diseases severely restrict other non-autoimmune cytopenia; individuals previously treated with cytotoxic drugs must include high-dose chemotherapy and AHSCT, or receive cytotoxic agents within one month of the study, or pregnancy or the risk of pregnancy; or who were unable to provide written informed consent according to the guidelines of the Research Ethics Committee; 2) Individuals participating in other clinical trails within 1 month prior to this study; 3) Patients who are not suitable for MRI check; 4) Any conditions the researchers found that are not inappropriate to receive AHSCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| expanded disability status scale, EDSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Brain and spinal MRI;adverse response and toxic effect;CD4+ and CD8+ cells; | — |
Contacts
Public ContactWang Hongxing
Xuanwu Hospital, Capital Medical University
Outcome results
None listed