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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03113162 |
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Date of registration:
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10/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) for Multiple Sclerosis
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Scientific title:
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Evaluation of the Safety and Efficacy of Reduced-intensity Immunoablation and Autologous Hematopoietic Stem Cell Transplantation (AHSCT) in Multiple Sclerosis |
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Date of first enrolment:
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May 29, 2015 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03113162 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Marviel T Berboso, RN |
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Address:
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Telephone:
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8888999 |
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Email:
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Inquiry.CTC@makatimed.net.ph |
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Affiliation:
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Name:
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Marviel T Berboso, RN |
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Address:
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Telephone:
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8888999 |
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Email:
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Inquiry.CTC@makatimed.net.ph |
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Affiliation:
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Name:
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Darwin Albert A Dasig, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makati Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: BEAM Regimen
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Biological: Autologous Hematopoietic Stem Cell
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Primary Outcome(s)
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Safety: Adverse Events
[Time Frame: 12 months]
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Secondary Outcome(s)
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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]
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Efficacy: EDSS Score
[Time Frame: 1 month post-infusion, 3 months month post-infusion, 6 months month post-infusion, 12 months month post-infusion]
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Secondary ID(s)
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MMCIRB 2015-024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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