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In vitro quality assessment of myogenic stem cells in multiple patient groups with confirmed skeletal muscle atrophy to study their potential for autologous stem cell therapy

In vitro quality assessment of myogenic stem cells in multiple patient groups with confirmed skeletal muscle atrophy to study their potential for autologous stem cell therapy - ATROMAB

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56403
Enrollment
80
Registered
2022-12-02
Start date
2023-12-07
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

muscle atrophy

Interventions

N.V.T.

Sponsors

Maastricht Universitair Medisch Centrum +
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient group: cachexia - Diagnosed with non-small cell lung cancer (NSCLC), stage 3-4 - Diagnosed with cachexia (>5% unintentional body weight loss in past six months) - Age 50-60 and 60-70 - Written informed consent Patient group: muscle impaired elderly - Scheduled for knee-, back- or hip surgery - Age 60-70 and 70-80y - Written informed consent Controls - Scheduled for knee-, back- or hip surgery - Age 50-60, 60-70 and 70-80 - Written informed consent

Exclusion criteria

Exclusion criteria: - No informed consent - Suffering from a muscular dystrophy or other disease known to affect muscle morphology or function - Have a weekly alcohol intake of >= 35 units (men) or >= 24 units (women) - Ongoing participation in other intervention clinical trials - Major surgery within 4 weeks of the visit - Patients unable and/or unwilling to comply with treatment and study instructions - Any other factor that in the opinion of the investigator excludes the patient from the study

Design outcomes

Primary

MeasureTime frame
Immunophenotype characterization of mesoangioblasts (i.e. number of the correct cells isolated from a muscle biopsy) by Alkaline phosphatase staining to determine stemness (>50%); and cell sorting via magnetic-activated cell sorting (MACS) and/or fluorescent-activated cell sorting (FACS) depending on surface antigens (>50%) • Proliferation rate of mesoangioblasts in vitro (population doubling level: >2 every 3-4 days) • Muscle regenerative capacity of mesoangioblasts in terms of the formation of multinucleated mature myotubes (>25% of total nuclei).

Secondary

MeasureTime frame
- The metabolic health of the mesoangioblasts, based on mitochondrial parameters (mitochondrial activity, mitochondrial DNA copy number, ATP production). This should not be below 50%, compared to age-matched controls. - The homing potential of the mesoangioblasts in these patients by characterizing inflammatory parameters. Muscle damage reflected by inflammation is essential for the migration and engraftment of mesoangioblasts in the affected muscles. (Inflammation) markers are determined in blood via an ELISA assay (descriptive). - Identify a potential difference between mesoangioblasts and satellite cells as a response to cachexia and sarcopenia. o Number of satellite cells present in muscle tissue via (immuno)histochemistry (descriptive) o Muscle regenerative capacity of satellite cells in terms of the formation of multinucleated mature myotubes (descriptive). o Proliferation rate of satellite cells in vitro (descriptive)

Countries

Netherlands

Contacts

Public ContactN Wanders

Universiteit Maastricht

n.wanders@maastrichtuniversity.nl+31 43 388 3986

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 19, 2026