A Long-term Follow-up Study of Patients Who Received MB-105
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MB-105.
- Who it may be relevant to
- Registry conditions: Any Patient Treated With MB-105. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study is to fulfil the regulatory requirement for 15-year follow-up for patients treated with MB-105 in any study
Detailed description
This study is for long term follow up of efficacy and safety for any patient treated with MB-105 who has consented to joining the LTFU study. There are no exclusion criteria.
Interventions
- Biological MB-105
This is an observational study with no study product administered because it is the LTFU study for patients who received the product in another study
Primary outcome measures
- Assess long term safety of MB-105 in patients who received MB-105 [Time frame: 15 Years]
Secondary outcome measures (1)
- Assess long term efficacy of MB-105 in patients who received MB-105 [Time frame: 15 Years]
Eligibility criteria
Inclusion criteria
Received MB-105 Signed informed consent Agree to transfer of samples from previous study Able to comply with study requirements
Exclusion criteria
N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07340814 · MB-105-202