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Assess effect and safety of intra-arterial autologous mesoangioblast administration to the upper arm of m.3243A>G mutation carriers
EU CTIS ID: 2024-515129-27-00
What this study is testing
Assess effect of three intra-arterial administrations of autologous MABs to the BB muscle on of m.3243A>G patients by assessing strength and fatigue in BB muscles of both arms before and after last MABs administration in left arm. Assess safety of the three ATMP administrations to the upper left arm by checking for SAEs, vascular obstructions and changes in neurological vital signs.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent, Age: 18-64, Sex: male/female, Patients with the hetroplasmic m.3243A>G mutation.
You likely can't join if
- Use of dabigatran, apixaban, edoxaban or rivaroxaban (DOACs) as anti-coagulants; Have a weekly alcohol intake of ≥ 35 units (men) or ≥ 24 units (women); Current history of drug abuse; Deficient immune system or autoimmune disease; Significant concurrent illness; Ongoing participation in other clinical trials with intervention; Pregnant or lactating women; Psychiatric or other disorders likely to impact on informed consent; Patients unable and/or unwilling to comply with treatment and study instructions - A history of strokes with signs of extra-pyramidal or pyramidal syndrome - Allergy for contrast fluid - Peripheral signs of ischemia or vasculopathy; Any other factor that in the opinion of the investigator excludes the patient from the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.