Abstract
Background: Autologous Stem Cell Transplant (ASCT) has been shown to provide long periods of progression free survival in Multiple Sclerosis (MS). Over the past many years many groups have done the procedure in various groups of patients with different types of MS and using different conditioning regimens. Aims: This is an observational study to demonstrate safety of ASCT in MS patients at a transplant centre in North India using a lymphoablative regimen. Methods: The study was conducted from January 2017 and December 2018. MS patients who were either referred by a neurologist or who came of their own volition were evaluated. Kurtzke Expanded Disability Status Scale (EDSS) score was calculated and those with a score of >7 were excluded. Patients <18 years were excluded. Informed written consent was taken. Mobilization was done with G-CSF (10 μg/kg/day) with prednisolone (1 mg/kg/day) to prevent disease flare-up. A minimum of 2 × 106 CD34 cells/kg were collected. Conditioning regimen consisted of Rabbit ATG 0.5 mg/kg on day -6 followed by 1 mg/kg on day -5 to -2 and Cyclophosphamide 50 mg/kg on day-5 to -2. Rituximab 375 mg/m2 was given on day-7 and day+30 to prevent EBV reactivation and disease relapse. Antibiotic prophylaxis was given with levofloxacin, fluconazole and valacyclovir. Any persistent change in the EDSS score ≥0.5 was considered significant. Results: A total of 34 patients were included in this study. Ten patients had positive urine cultures prior to transplant and were treated before starting any chemotherapy.Majority (73%) of the patients were women (25/34). There was one patient of PPMS, sixteen of RRMS, and remaining were SPMS(50%). The median EDSS score was 5.5. The median age of the study population was 32 years. Mobilization was easily achieved with G-CSF with no disease flare ups. The median CD34 cell harvest was 5.71 × 106 cells/kg. All patients developed febrile neutropenia which was managed as per department policy. There was no mortality during peri transplant up to day+100. One patient of SPMS died following intracerebral bleed on day +120 unrelated to transplant complications. Subjective symptoms improved in majority (30/34) patients. EDSS score improved in 11/34 patients (8/11 with RRMS) with disease progression in 3/34 patients at a median follow up duration of 562 days. Five out of nine RRMS patients with active disease on MRI had a response. Summary/Conclusion: The study shows that ASCT can be done safely for patients with relatively high EDSS scores with additional precautions for screening for infections. RRMS patients with active disease on MRI show the most improvement. SPMS patients may not show significant improvement in the short term.
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