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

May 3, 2017 updated by: Darwin A. Dasig, Makati Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Hematopoietic Stem Cell with BEAM Regimen
Autologous HSCT following Reduced-Intensity BEAM Regimen
Biological: Autologous Hematopoietic Stem Cell
Drug: BEAM Regimen
Reduced-intensity BEAM for Immunoablation
Other Names:
  • BCNU, Etoposide, Cytarabine, Melphalan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: EDSS Score
Time Frame: 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
1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion
Efficacy: RAND-36 Score
Time Frame: 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
1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makati Medical Center

Investigators

  • Principal Investigator: Darwin Albert A Dasig, MD, Makati Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2015

Primary Completion (Anticipated)

May 29, 2020

Study Completion (Anticipated)

May 29, 2022

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMCIRB 2015-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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