Status unknownPhase 1Progressive MSNCT03113162

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Autologous Hematopoietic Stem Cell
  • Carmustine

    DNA inhibitor|Glutathione reductase inhibitor|RNA inhibitor

What it measured

Main measures

  • Safety: Adverse Events

    12 months

    Safety

Other measures (2)

  • Efficacy: EDSS Score

    1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion

    Disability progression
  • Efficacy: RAND-36 Score

    1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion

    Quality of life (reported by participants)

Who could take part

Progressive MS · 18 to 60

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      May 2015

    2. Main results due

      May 2020

    3. Finished

      May 2022

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error