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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.
Register: ClinicalTrials.gov
Last refreshed on: 31 August 2015
Main ID:  NCT02529839
Date of registration: 10/06/2015
Prospective Registration: Yes
Primary sponsor: Hadassah Medical Organization
Public title: Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)
Scientific title: Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis
Date of first enrolment: October 2015
Target sample size: 20
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT02529839
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Contacts
Name:     Igor Resnick, Prof.
Address: 
Telephone: 972-50-787-4663
Email: gashka.resnick@gmail.com
Affiliation: 
Name:     Igor Resnick, Prof.
Address: 
Telephone:
Email:
Affiliation:  Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Consenting patients fulfilling the Poser's clinical criteria for definite MS

2. Age: 18-65, males and females

3. Relapsing and secondary progressive forms of MS with evidence of significant
activity of MS (clinical and on the MRI).

4. EDSS score of 2.0 to 7.0 (see table 1).

5. Failure to at least one line of the currently available treatment, registered
treatments (i.e. interferons, Copaxone, Tysabri, Gilenya, Tecfidera,
immunosuppression) for MS. The lack of response to these treatments will be
determined/defined by either an increase (deterioration) of one degree (or more) in
the EDSS score, when baseline EDSS is less than 5.0 or 0.5 degree, when baseline EDSS
is 5.0 or more, during the last year or the appearance of one major relapse of MS
during the same period of time (under treatment), or evidence for new activity of MS
(new T2 lesions or gadolinium enhancing lesions) during the last 12 months.

6. Duration of disease: >2 years, except cases with rapid progression, i.e. annual
relapse rate =2 per 2 years on a conventional treatment or malignant multiple
sclerosis with very intense symptoms (types is in most cases deadly).

Exclusion Criteria:

1. Patients suffering from significant cardiac, renal or hepatic failure or any other
disease that may risk the patient or interfere with the ability to undergo high dose
immunosuppression associated toxicities (according to the existing limitations for
autologous transplantation).

2. Patients with active infections.

3. Patients with severe cognitive decline or inability to understand and sign the
informed consent.

4. Patients who were treated with investigational protocols during the last 3 months
prior to the inclusion.

5. Patients who received high dose immunosuppression with autologous stem cell rescue in
the past with no effect.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Drug: Alemtuzumab
Drug: Fludarabine
Procedure: Autologous bone marrow transplantation
Drug: Cyclophosphamide
Primary Outcome(s)
Transplant related mortality by Day 100 [Time Frame: Day 100]
Engraftment parameters of Neutrophils and Platelets [Time Frame: 1 year]
Secondary Outcome(s)
Overall survival (OS) at 1 year [Time Frame: 1 year]
Changes in the Expanded Disability Status Scale (EDSS score, as compared to baseline) [Time Frame: 1 year]
Progression-free survival (PFS) at 1 year [Time Frame: 1 year]
Changes in MRI activity [Time Frame: 1 year]
Secondary ID(s)
0105-15-HMO-CTIL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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