drugset / Trial / NCT02282514

Stem Cell Transplantation for Stiff Person Syndrome (SPS)

NCT02282514

Phase 1/2 Terminated 23 enrolled Northwestern University
NaSingle-groupOpen-labelTreatment

Summary

Non-myeloablative regimens (as the investigators use herein) are designed to maximally suppress the immune system without destruction of the bone marrow stem cell compartment. When using a non-myeloablative regimen recovery occurs without infusion of stem cells and the stem cells are autologous. While not necessary for recovery, stem cell infusion may shorten the interval of neutropenia and attendant complications. Thus in reality there is no transplant only an autologous supportive blood product. Based on our encouraging results of non-myeloablative hematopoietic stem cell transplantation, for patients with multiple sclerosis and chronic inflammatory demyelinating polyneuropathy, the investigators will investigate the role of non-myeloablative hematopoietic stem cell transplantation for patients with SPS who require assistance to ambulate.

Timeline

Start
2014-10
Primary completion
2019-08-19
Completion
2019-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject autologous hematopoietic stem cells Cell therapy Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule Intravenous
Background Cyclophosphamide Other / unclassified 200 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 2 g Intravenous
Background G-CSF Protein / enzyme biologic 5 ug/kg Subcutaneous
Background G-CSF Protein / enzyme biologic 10 ug/kg Subcutaneous
Background Methylprednisolone Other / unclassified 1000 mg Intravenous
Background Rituximab Monoclonal antibody 500 mg Intravenous
Background Thymoglobulin Protein / enzyme biologic 1.5 mg/kg Intravenous