Muscle Stem Cell Quality in Atrophy

NCT06077734 | Terminated DMC

• 1 other identifier: NL 81090.068.22
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Weakness; Atrophy, Muscle; Cachexia; Sarcopenia; Stem Cell Transplantation; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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.

  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.

  1 day

Secondary Outcomes (3)

• Homing potential of mesoangioblasts in vitro

  1 day

• ATP production of mesoangioblasts in vitro

  1 day

• Difference in myogenic potential of mesoangioblasts and satellite cells in vitro

  1 day

Study Arms (3)

Muscle impaired elderly

Elderly scheduled for hip/knee/back surgery with III-IV ASA score, low grip strength and high scoring for sarcopenia

Other: In vitro analyse

Lung cancer cachexia

Non-small cell lung cancer patients stage III with reported cachexia

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.

Other: In vitro analyse

Interventions

In vitro analyse OTHER

In vitro analysis on isolated mesoangioblasts obtained from muscle biopsies

Controls; Lung cancer cachexia; Muscle impaired elderly

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht Universitair Medisch Centrum

Maastricht, Limburg, 6229HX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood sample (venous) * Muscle biopsy (vastus lateralis)

MeSH Terms

Conditions

Muscle Weakness; Muscular Atrophy; Cachexia; Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical; Weight Loss; Body Weight Changes; Body Weight; Thinness

Study Officials

• Monique Hochstenbag, MD, PhD

  Maastricht University Medical Centre

  STUDY DIRECTOR

• Bert Smeets, Professor

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: November 27, 2023
• Primary Completion: February 2, 2026
• Study Completion: February 16, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

NL (1)