Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT06228781
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous haemopoietic stem cell transplantation — PROCEDURE
    Immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT). Stem cell mobilization with cyclophosphamide 2g/m2 and filgrastim 10 ug/kg/d x 5 day. Stem cell collection with cobe cpectra stem cell purification with Miltenyi CliniMACS Stem cell transplant conditioning with busulphan 3.2 mg/kg ; fludarabine 30mg/m2 or cladribine 10mg ；cytarabine 1-2g/m2 or idarubicin 8mg/m2；cyclophosphamide 40mg/kg followed by CD34 selected autologous hematopoietic stem cell transplant.

Study Details

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.

Key Dates

First listed
Jan 29, 2024
Start date
Dec 1, 2026
Status verified
May 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Hematopoietic Stem Cell Transplantation
    Patients will undergo stem cell transplantation for the treatment of refractory MS

Primary Outcome Measure

3 year MS activity free survival [ Time Frame: 3 year follow-up post transplant ]

Central Contacts

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