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Assess efficacy of intra-arterial autologous myogenic stam cell therapy for m.3243A>G mutation carriers

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515129-27-00
Enrollment
20
Registered
2024-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

m.3243A>G mutation causing mitochondrial myopathy

Brief summary

Assessment of safety parameters (angiography, 8h post-procedure monitoring of neurological vital signs, (S)AE) and assessment of changes in muscle strength and muscle fatigue of treated and untreated biceps brachii muscle using Biodex dynamometer measurements at baseline and 4-6 weeks after the third ATMP administration.

Detailed description

Assess muscle mass, morphology, m.3243A>G mutation load and mitochondrial respiratory capacity in muscle biopsies of treated BB muscle

Interventions

Sponsors

Academisch Ziekenhuis Maastricht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Assessment of safety parameters (angiography, 8h post-procedure monitoring of neurological vital signs, (S)AE) and assessment of changes in muscle strength and muscle fatigue of treated and untreated biceps brachii muscle using Biodex dynamometer measurements at baseline and 4-6 weeks after the third ATMP administration.

Secondary

MeasureTime frame
Assess muscle mass, morphology, m.3243A>G mutation load and mitochondrial respiratory capacity in muscle biopsies of treated BB muscle

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026