TerminatedNot Applicable

Muscle Stem Cell Quality in Atrophy

Stopped: This study was terminated prior to its planned completion due to unexpected low participant inclusion.

Netherlands7 participantsStarted 2023-11-27

Plain-language summary

The goal of this clinical trial is to compare the quality of mesoangioblasts isolated from various patient groups suffering from muscle atrophy. This study includes cancer cachexia and muscle-impaired elderly and a control group of the same age. The quality will be defined on these following outcomes: * The number and distribution of the mesoangioblasts in a muscle biopsy to define if there are sufficient mesoangioblasts to start a culture. * The proliferation capacity to define if we can culture them the numbers required for systemic treatment. * The myogenic capacity to define if the mesoangioblasts are sufficiently capable to generate muscle fibres. Participants will: * Undergo a muscle biopsy (needle biopsy or rest material from surgery, \~50mg) * Donate blood (\~20 ml) * Fill in SARC-F questionnaire (evaluate sarcopenia score) * Fill in SQUASH questionnaire (evaluate physical activity of previous week) Researchers will compare groups (muscle-impaired elderly vs control; cancer cachexia vs control) to see if there is a difference regarding quality. These results will define the potential of autologous mesoangioblast therapy within these groups.

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Lung cancer cachexia: * Diagnosed with NSCLC, stage III-IV * Diagnosed with cachexia (\>5% unintentional body weight loss in past six months, \>2% body weight loss with BMI \<20, or skeletal muscle index for males \<7.26 kg/m2; females \<5.45 kg/m2) * Age 50-60 or 60-70 * Written informed consent Patient group: MIE * Scheduled for total hip, knee, or back surgery * Age 60-70 or 70-80 year * Written informed consent Controls * Patients with scheduled knee-, hip-, and back surgery * Age 50-60, 60-70, and 70-80 year * Age and sex-matched to patient groups * Written informed consent Exclusion Criteria: * No filled-in IC * 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 of the muscle within 4 weeks of the visit unrelated to the study * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of mesoangioblasts ex vivo isolated from muscle biopsy

Timeframe: 1 day

Proliferation capacity of mesoangioblasts in vitro

Timeframe: 1 day

Myogenic capacity of mesoangioblasts in vitro

Timeframe: 1 day

Distribution of mesoangioblasts in a muscle biopsy

Timeframe: 1 day

Trial details

NCT IDNCT06077734

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-02

View on ClinicalTrials.gov More Muscle Weakness trials

Plain-language summary

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.