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Observational Study in Multiple Sclerosis Patients Treated With Autologous Hematopoietic Stem Cell Transplantation
Study Purpose
Observational prospective , multi-center study. Primary objective : To gain further homogenous evidence for clinical efficacy of aHSCT in patients undergoing aHSCT for MS as primary indication. Secondary objectives:
- - Safety, tolerability and toxicity of aHSCT in MS.
- - Quality of life and long-term disability after aHSCT.
- - MRI outcome after aHSCT.
- - Overall survival.
- - Transplant related mortality.
- - MRI Assessment including lesions.
- - Treatment-related complications.
- - Improvement of disability.
- - Diagnosis of MS according to the 2010 revision McDonald's criteria.
- - Availability of a detailed clinical history about MS, including progression of disability and relapse rate in the previous 2 years, previous treatments administered.
- - Patients aged 18yrs or over at the time of the first aHSCT.
- - Lack of one of the above criteria.
- - Physical, mental, or social condition which could affect the patient from returning for follow-up visits.
- - Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are considered part of routine patient care.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04674280 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
European Society for Blood and Marrow Transplantation |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Riccardo Saccardi, MD |
Principal Investigator Affiliation | European Society for Blood and Marrow Transplantation |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Sclerosis |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
EBMT ADWP- OMST study coordinator
For additional contact information, you can also visit the trial on clinicaltrials.gov.
Posting a Trial
If you would like us to post a study on these pages, please email studies@nmss.org to find out what information you need to submit for review.