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

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ClinicalTrials.gov Identifier: NCT03113162
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Darwin A. Dasig, Makati Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Autologous Hematopoietic Stem Cell Drug: BEAM Regimen Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) in Multiple Sclerosis
Actual Study Start Date : May 29, 2015
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : May 29, 2022

Resource links provided by the National Library of Medicine


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 Name: BCNU, Etoposide, Cytarabine, Melphalan




Primary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: 12 months ]
    Type, occurence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113162


Contacts
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Contact: Marviel T Berboso, RN 8888999 ext 3613 Inquiry.CTC@makatimed.net.ph
Contact: Jose Maria C Avila, MD 8888999 ext 3614 stemcell@makatimed.net.ph

Locations
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Philippines
Makati Medical Center Recruiting
Makati, Philippines, 1229
Contact: Marviel T Berboso, RN    8888999 ext 3613    Inquiry.CTC@makatimed.net.ph   
Sponsors and Collaborators
Makati Medical Center
Investigators
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Principal Investigator: Darwin Albert A Dasig, MD Makati Medical Center

Publications:

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Responsible Party: Darwin A. Dasig, Principal Investigator, Makati Medical Center
ClinicalTrials.gov Identifier: NCT03113162     History of Changes
Other Study ID Numbers: MMCIRB 2015-024
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Darwin A. Dasig, Makati Medical Center:
multiple sclerosis
HSCT

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Carmustine
Melphalan
Cytarabine
Etoposide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Myeloablative Agonists