Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) for Multiple Sclerosis

• Status: Recruiting
• Trial end date: 2022-05-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a patient-sponsored study that evaluates the safety and efficacy of reduced-intensity immunoablation followed by a single dose autologous hematopoetic stem cell transplantation in patients diagnosed with multiple sclerosis. Patients are followed-up after 1 month, 3 months, 6 months and 12 months post-transplantation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makati Medical Center
• Treatments: Carmustine; Cytarabine; Etoposide; Melphalan

Criteria

Inclusion Criteria:

• Diagnosed with progressive multiple sclerosis with or without relapses

• EDSS score between 1.5 and 7.0, including documented rapid progression over the previous year unresponsive to conventional therapies or no available treatment options

• Aged between 18 and 60 with a history of at least one enhancing lesion on brain MRI

• With absolute neutrophil count ≥ 1,000/mm^3, platelet count ≥ 100,000/mm^3 and hemoglobin ≥ 9.0 g/dL

Exclusion Criteria:

• Patients with cardiac, renal, pulmonary, hepatic, or other organ impairment that would limit their ability to receive dose-intensive immunosuppressive therapy, high-dose chemotherapy, and/or Autologous HSCT

• Patients with any active or chronic infection e.g. uncontrolled viral, fungal, or bacterial infection

• Uncontrolled diabetes

• Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C

• Patients whose life expectancy is severely limited by another illness

• Patients with evidence of myelodysplasia or other non-autoimmune cytopenia

• Patients having received a cytotoxic agent within one month prior to this study

• Patients who are pregnant or at risk of pregnancy, including those unwilling to practice

• Patients with psychiatric illness, mental deficiency, or cognitive dysfunction

• Patients unable to give written informed consent in accordance with research ethics board guidelines