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

Evaluation of the Safety and Efficacy of Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) in Multiple Sclerosis

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03113162

Enrollment

Registered

2017-04-13

Start date

2015-05-29

Completion date

2022-05-29

Last updated

2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, HSCT

Brief 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.

Interventions

BIOLOGICALAutologous Hematopoietic Stem Cell

DRUGBEAM Regimen

Reduced-intensity BEAM for Immunoablation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety: Adverse Events	12 months	Type, occurence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities

Secondary

Measure	Time frame	Description
Efficacy: EDSS Score	1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion	Measurement of disease progression by change in baseline of EDSS score
Efficacy: RAND-36 Score	1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion	Measurement of Quality of Life by change in baseline of RAND-36 score

Countries

Philippines

Contacts

Primary ContactMarviel T Berboso, RN

Inquiry.CTC@makatimed.net.ph8888999

Backup ContactJose Maria C Avila, MD

stemcell@makatimed.net.ph8888999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026