NL-OMON55910
Not yet recruiting
Phase 2
Assess effect and safety of intra-arterial autologous mesoangioblasts administration to the upper arm of m.3243A>G mutation carriers - Effect and safety MABs administration m.3243A>G carriers
Medisch Universitair Ziekenhuis Maastricht0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Written informed consent \- Age: 18\-64 year \- Sex: male/female \- Patients with
- •the m.3243A\>G mutation load of 50%\-90% determined in skeletal muscle or derived
- •from age\-corrected calculation of blood m.3243A\>G mutation load
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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