Multiple Sclerosis Clinical Trial
Official title:
Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | January 1, 2029 |
Est. primary completion date | January 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 year MS activity free survival | The events for the primary outcome are: clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score. | 3 year follow-up post transplant | |
Secondary | Time to MS treatment failure | Disease activity and disability will be assessed with clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score and quality of life. | 3 years | |
Secondary | Transplant related morbidity | Rate of transplant related events. | 3 years | |
Secondary | Transplant related mortality | Rate of transplant related death. | 3 years | |
Secondary | Immune reconstitution following transplant | Rate of immune reconstitution following transplant. | 3 years | |
Secondary | Hematopoietic reconstitution following transplant | Rate of hematopoietic reconstitution following transplant. | 3 years | |
Secondary | Imaging changes associated with the disease activity | Imaging changes include: new or enlarging T2-weighted lesion count and new T1-weighted lesion count at all scans after baseline; T2-weighted lesion volume; Gd-enhanced lesion count and volume; and total volume of non-enhancing T1-weighted lesions on all MRI scans. |
3 years |
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