Autologous Hematopoietic Stem Cell Transplantation for Refractory Mult
Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Autologous haemopoietic stem cell transplantation
What it measured
Main measures
3 year MS activity free survival
3 year follow-up post transplant
Disability progressionRelapsesMRI lesions
Other measures (6)
Time to MS treatment failure
3 years
Disability progressionRelapsesMRI lesionsQuality of life (reported by participants)Transplant related morbidity
3 years
Transplant related mortality
3 years
Immune reconstitution following transplant
3 years
Hematopoietic reconstitution following transplant
3 years
Imaging changes associated with the disease activity
3 years
MRI lesions
Who could take part
MS (type not specified) · 18 to 60 · EDSS 3 to 6
Show the full criteria
Inclusion criteria
1. Age 18-60 years; 2. Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field; 3. EDSS score of 3-6 (including 3 and 6); 4. EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3； 5. Evidence of current disease activity; 6. If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ; 7. No evidence of hepatic inflammation or fibrosis;
Exclusion criteria
1. Patients with evidence of myelodysplasia or other non-autoimmune cytopenia; 2. Patients having received a cytotoxic agent within one month of enrolling in this study; 3. Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.); 4. Patients having received a cytotoxic agent within one month of enrolling in this study; 5. Patients with a malignant tumor currently or within the last 5 years; 6. Patients with cardiac, renal, pulmonary, hepatic or other organ impairment; 7. Patients whose life expectancy is severely limited by another conditions; 8. Pregnancy or risk of pregnancy; 9. Patients unable to give written informed consent in accordance with research ethics board guidelines.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS.
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History
Started
Dec 2026
Main results due
Jan 2029
Finished
Jan 2029