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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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.
Primary endpoint : Time to failure to maintain a NEDA status. Secondary endpoints:
  • - Overall survival.
  • - Transplant related mortality.
  • - MRI Assessment including lesions.
  • - Treatment-related complications.
. • Quality of life through the MS QL 54 standard assessment.
  • - Improvement of disability.
Inclusion criteria:
  • - 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.
Exclusion criteria:
  • - 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: 50 patients Recruitment period: 2 years starting from the inclusion of the 1st patient Follow-up duration: 2 years

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
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of MS according to McDonald's criteria.
  • - Availability of a detailed clinical history about MS, including progression of disability and relapse rate in the previous 2 years, treatments administered before aHSCT, and categorization of the sub-types of MS according to current EBMT guidelines.
  • - Highly active relapsing remitting MS failing DMTs.
  • - Progressive MS with active inflammatory component.
In accordance with the EBMT guidelines, this category includes both secondary and primary progressive MS with active inflammatory component.
  • - Aggressive (malignant) MS not previously treated with a full course of DMT.
  • - Patients aged 18 or over at time of first aHSCT.
  • - Signed informed consent.

Exclusion Criteria:

  • - Lack of one of the above criteria.
  • - Progressive MS without active inflammatory component, as this indication is assigned 'GNR' according to EBMT guidelines, irrespective of whether it is secondary or primary progressive.
  • - Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient be able to return for the scheduled 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.

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.

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
Additional Details

Currently, a number of new prospective comparative trials have either started or are in preparation, and the EBMT guidelines recommend treatment on a clinical trial, where available. However, some MS patients receiving aHSCT will not be eligible for these trials, which are predominantly focussed on a tightly defined group of patients with highly active RRMS. In addition, access to such trials is not universal across EBMT and therefore there is a need for structured data collection. The investigators propose here to conduct an observational cohort study that systematically gathers experience from MS patients, for whom an adequate set of data about their clinical history and their clinical situation at baseline is available; patients will be then be followed prospectively according to their local clinical center protocol. The expectation is that local clinical protocols will be in line with the current EBMT guidelines and recommendations. Therefore, the aim will be to prospectively and non-interventionally capture a complete dataset to safety, tolerability and efficacy outcomes for aHSCT in various sub-types of MS treated in accordance with the current EBMT guidelines and recommendations. Alongside ongoing clinical trials, the investigators hope this study will meaningfully inform the evidence-base and future guidelines and recommendations for good clinical practice. 1- Study design Multi-centre, non-interventional prospective study in patients diagnosed with Multiple Sclerosis, treated with aHSCT. 2 Aims and objectives of the study. 1. Primary objectives.

  • - To evaluate the outcome of patients undergoing aHSCT for MS as primary indication.
2. Secondary objectives.
  • - To gain further knowledge on safety, tolerability and toxicity of aHSCT in MS.
  • - To gain further knowledge on the quality of life and long-term disability of patients treated with aHSCT.
  • - To gain further knowledge about the MRI outcome after aHSCT.
3. Study schedule The clinical assessment at enrolment and during follow-up will be carried out according to local policies, with the expectation that centres will be working in line with the EBMT Guidelines and Recommendations for MS and immune-mediated neurological diseases. However, based on common clinical practice in patients with MS on therapy, an MRI and one neurological assessment are usually carried out yearly. Baseline MRI should be carried out within 3 months before the start of the mobilization regimen, whilst neurological examination should be accomplished as baseline assessment no more than one month before the start of the treatment. Enrolment time is 2 years from the registration of the first patient. Follow-up is anticipated for 24 months from individual start of treatment.

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

[email protected]

+33.1.70.64.24.16

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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