Muscle WeaknessATROMABNCT06077734
Muscle Stem Cell Quality in Atrophy
An observational study of Muscle Weakness and Atrophy, Muscle, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Muscle Weakness, Atrophy, Muscle, Cachexia
- What is being tested?
- In vitro analyse
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Nov 2023to 16 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two study populations are included in this study. The Muscle Impaired Elderly (MIE) are considered elderly who struggle with muscle weakness. MIE is used as a substitute group for sarcopenia as their muscle weakness and daily impairments are confirmed, but confirmation via medical imaging lacks. Sarcopenia is multifactorial and the balance between nutrition and activity is disturbed. Cachexia is defined as an ongoing loss of skeletal muscle mass due to an illness that cannot be reversed by conventional nutrition and/or exercise. Lung cancer cachexia is a group where non-small cell lung cancer is confirmed along with non-intentional weight loss. Both groups will be compared to a Control group consisting of eldery undergoing knee/hip/back surgery but are otherwise considered healthy.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht Universitair Medisch Centrum
Maastricht, Limburg, 6229HX
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
No effective treatment is available for the loss of muscle tissue in non-genetic muscle diseases such as (cancer) cachexia and sarcopenia. Such a treatment would improve the quality of life, therapy success, and independency of these patients. The administration of healthy autologous muscle stem cells, called mesoangioblasts, that lead to muscle regeneration and increased muscle mass and function could be a novel therapeutic strategy to achieve this. A prerequisite is that the therapeutic potential of these mesoangioblasts is sufficient. Therefore, the main aim of this study is to assess this potential for mesoangioblasts of patients with lung cancer cachexia and with sarcopenia and determine the effect the cancer or age might have on the therapeutic potential.
This study is part of a larger project, called Generate Your Muscle (GYM), which aims to develop and commercially produce a stem cell therapy for recovery of muscle mass and strength in patients with genetic and non-genetic muscle disease and muscle breakdown. This will be achieved by administering large numbers of autologous mesoangioblasts (MABs) as an Advanced Therapy Medicinal Product (asCTMP) in the arteries, which will migrate to the damaged muscle, thereby restoring muscle mass and function. This strategy can only be successful for patients suffering from cachexia or sarcopenia, if these patients have enough mesoangioblasts, if these MABs can proliferate into the numbers requested for systemic treatment, if the energy capacity of the MABs is sufficient and if these mesoangioblasts still have a high myogenic potential. The aim of this study is to determine these parameters for patients with cancer cachexia or sarcopenia, as we know that they can be affected by the underlying condition. They will be compared to age-matched controls. If positive, the MABs will qualify as asCTMP for a clinical trial in a follow-up study.
- Conditions
- Muscle Weakness, Atrophy, Muscle, Cachexia, Sarcopenia, Stem Cell Transplantation, Mesenchymal Stem Cells
- Being tested
- In vitro analyse
- Medical subject headings
- Muscle Weakness, Muscular Atrophy, Cachexia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro analyseOther
In vitro analysis on isolated mesoangioblasts obtained from muscle biopsies
| Study group | Role | What they receive |
|---|---|---|
| Muscle impaired elderly | Elderly scheduled for hip/knee/back surgery with III-IV ASA score, low grip strength and high scoring for sarcopenia Receives: Other: In vitro analyse | |
| Lung cancer cachexia | Non-small cell lung cancer patients stage III with reported cachexia Receives: Other: In vitro analyse | |
| Controls | Elderly scheduled for hip/knee/back surgery without any recorded muscle defects, I-II ASA score, average or high grip strength, low scoring for sarcopenia. Receives: Other: In vitro analyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mesoangioblasts ex vivo isolated from muscle biopsy
The number of mesoangioblasts obtained from a muscle biopsy. Once cells reached >80% confluency in a culture dish, FACS analysis will determine the amount of mesoangioblasts obtained.
Measured: 1 day
Proliferation capacity of mesoangioblasts in vitro
The proliferation capacity to define whether we can culture them in the numbers required for systemic treatment. Doubling time will be assessed 3 separate instances with a hemocytometer. Population doubling level = 3.32 (log viable cells at harvest - log seeded cells)
Measured: 1 day
Myogenic capacity of mesoangioblasts in vitro
The myogenic capacity to define if the mesoangioblasts are sufficiently capable to generate muscle fibres. Myogenic capacity is calculated as the number of nuclei in MF20-positive fibers divided by total number of nuclei per field.
Measured: 1 day
Distribution of mesoangioblasts in a muscle biopsy
The number of mesoangioblasts in a muscle biopsy. Histochemistry will reveal the location of the pericyte-like mesoangioblasts surrounding the blood vessels when stained for pericyte marker NG2 proteoglycan.
Measured: 1 day
Secondary outcomes (3)
Homing potential of mesoangioblasts in vitro
The homing potential of the mesoangioblasts in these patients by characterizing inflammatory parameters via qPCR. Muscle damage reflected by inflammation is essential for the migration and engraftment of mesoangioblasts in the affected muscles. Differences in gene expression levels of cytokine IL6 and cytokine mediator HMGB1 in the groups MIE and Lung cancer patients vs Controls will be determined.
Measured: 1 day
ATP production of mesoangioblasts in vitro
ATP production as a marker for metabolic health will be determined via the CellTiterGlo assay. Luminescence (Relative Light Unit) corrected for DNA content per well determines the ATP production.
Measured: 1 day
Difference in myogenic potential of mesoangioblasts and satellite cells in vitro
Differences in myogenic potential between mesoangioblasts and satellite cells with respect due cachexia and sarcopenia. Myogenic capacity is calculated as the number of nuclei in MF20-positive fibers divided by total number of nuclei per field.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start27 Nov 2023
- Primary completion2 Feb 2026
- Study completion16 Feb 2026
Why it stopped: This study was terminated prior to its planned completion due to unexpected low participant inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monique Hochstenbag, MD, PhD, Study director, Maastricht University Medical CentreBert Smeets, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077734
- Sponsor's protocol ID
- NL 81090.068.22
- Acronym
- ATROMAB
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06077734
- Acronym / sponsor ID
- ATROMAB / NL 81090.068.22
- Conditions
- Muscle Weakness, Atrophy, Muscle, Cachexia, Sarcopenia, Stem Cell Transplantation, Mesenchymal Stem Cells
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated prior to its planned completion due to unexpected low participant inclusion.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
No effective treatment is available for the loss of muscle tissue in non-genetic muscle diseases such as (cancer) cachexia and sarcopenia. Such a treatment would improve the quality of life, therapy success, and independency of these patients. The administration of healthy autologous muscle stem cells, called mesoangioblasts, that lead to muscle regeneration and increased muscle mass and function could be a novel therapeutic strategy to achieve this. A prerequisite is that the therapeutic potential of these mesoangioblasts is sufficient. Therefore, the main aim of this study is to assess this potential for mesoangioblasts of patients with lung cancer cachexia and with sarcopenia and determine the effect the cancer or age might have on the therapeutic potential.
This study is part of a larger project, called Generate Your Muscle (GYM), which aims to develop and commercially produce a stem cell therapy for recovery of muscle mass and strength in patients with genetic and non-genetic muscle disease and muscle breakdown. This will be achieved by administering large numbers of autologous mesoangioblasts (MABs) as an Advanced Therapy Medicinal Product (asCTMP) in the arteries, which will migrate to the damaged muscle, thereby restoring muscle mass and function. This strategy can only be successful for patients suffering from cachexia or sarcopenia, if these patients have enough mesoangioblasts, if these MABs can proliferate into the numbers requested for systemic treatment, if the energy capacity of the MABs is sufficient and if these mesoangioblasts still have a high myogenic potential. The aim of this study is to determine these parameters for patients with cancer cachexia or sarcopenia, as we know that they can be affected by the underlying condition. They will be compared to age-matched controls. If positive, the MABs will qualify as asCTMP for a clinical trial in a follow-up study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Muscle impaired elderly | – | Other: In vitro analyseElderly scheduled for hip/knee/back surgery with III-IV ASA score, low grip strength and high scoring for sarcopenia |
| Lung cancer cachexia | – | Other: In vitro analyseNon-small cell lung cancer patients stage III with reported cachexia |
| Controls | – | Other: In vitro analyseElderly scheduled for hip/knee/back surgery without any recorded muscle defects, I-II ASA score, average or high grip strength, low scoring for sarcopenia. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two study populations are included in this study. The Muscle Impaired Elderly (MIE) are considered elderly who struggle with muscle weakness. MIE is used as a substitute group for sarcopenia as their muscle weakness and daily impairments are confirmed, but confirmation via medical imaging lacks. Sarcopenia is multifactorial and the balance between nutrition and activity is disturbed. Cachexia is defined as an ongoing loss of skeletal muscle mass due to an illness that cannot be reversed by conventional nutrition and/or exercise. Lung cancer cachexia is a group where non-small cell lung cancer is confirmed along with non-intentional weight loss. Both groups will be compared to a Control group consisting of eldery undergoing knee/hip/back surgery but are otherwise considered healthy.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vitro analyseIn vitro analysis on isolated mesoangioblasts obtained from muscle biopsies | Other | Controls, Lung cancer cachexia, Muscle impaired elderly |
Primary outcome
Number of mesoangioblasts ex vivo isolated from muscle biopsy
Time frame: 1 day
The number of mesoangioblasts obtained from a muscle biopsy. Once cells reached >80% confluency in a culture dish, FACS analysis will determine the amount of mesoangioblasts obtained.
Proliferation capacity of mesoangioblasts in vitro
Time frame: 1 day
The proliferation capacity to define whether we can culture them in the numbers required for systemic treatment. Doubling time will be assessed 3 separate instances with a hemocytometer. Population doubling level = 3.32 (log viable cells at harvest - log seeded cells)
Myogenic capacity of mesoangioblasts in vitro
Time frame: 1 day
The myogenic capacity to define if the mesoangioblasts are sufficiently capable to generate muscle fibres. Myogenic capacity is calculated as the number of nuclei in MF20-positive fibers divided by total number of nuclei per field.
Distribution of mesoangioblasts in a muscle biopsy
Time frame: 1 day
The number of mesoangioblasts in a muscle biopsy. Histochemistry will reveal the location of the pericyte-like mesoangioblasts surrounding the blood vessels when stained for pericyte marker NG2 proteoglycan.
3 secondary outcomes
Homing potential of mesoangioblasts in vitro
Time frame: 1 day
ATP production of mesoangioblasts in vitro
Time frame: 1 day
Difference in myogenic potential of mesoangioblasts and satellite cells in vitro
Time frame: 1 day
Results and safety
The study was stopped early (reason given: This study was terminated prior to its planned completion due to unexpected low participant inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Hochstenbag, MD, PhD study director
Maastricht University Medical Centre
Bert Smeets, Professor principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness and Atrophy, Muscle, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated prior to its planned completion due to unexpected low participant inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mesoangioblasts ex vivo isolated from muscle biopsy (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.