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

NCT ID: NCT03113162

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-29
• Study Completion Date: 2022-05-29

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Hematopoietic Stem Cell with BEAM Regimen

Autologous HSCT following Reduced-Intensity BEAM Regimen

Group Type: EXPERIMENTAL

Autologous Hematopoietic Stem Cell

Intervention Type: BIOLOGICAL

BEAM Regimen

Intervention Type: DRUG

Reduced-intensity BEAM for Immunoablation

Interventions

Autologous Hematopoietic Stem Cell

Intervention Type: BIOLOGICAL

BEAM Regimen

Reduced-intensity BEAM for Immunoablation

Intervention Type: DRUG

Other Intervention Names

BCNU, Etoposide, Cytarabine, Melphalan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makati Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Darwin A. Dasig

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darwin Albert A Dasig, MD

Role: PRINCIPAL_INVESTIGATOR

Makati Medical Center

Locations

Makati Medical Center

Makati, , Philippines

Site Status: RECRUITING

Countries

Philippines

Central Contacts

Marviel T Berboso, RN

Role: CONTACT

Inquiry.CTC@makatimed.net.ph

8888999 ext. 3613

Jose Maria C Avila, MD

Role: CONTACT

stemcell@makatimed.net.ph

8888999 ext. 3614

Facility Contacts

Marviel T Berboso, RN

Role: primary

Inquiry.CTC@makatimed.net.ph

8888999 ext. 3613

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Other Identifiers

MMCIRB 2015-024

Identifier Type: -

Identifier Source: org_study_id