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Artery DiseaseNCT03942445

In Vivo Analysis of Muscle Stem Cells in Chronic and Acute Lower Limb Ischemia (MyostemIschemia)

A study testing Gastrocnemius muscle biopsy in people with Artery Disease and Muscle Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Skeletal muscle regenerates after injury, due to the satellite cells (SCs), the muscle stem cells that activate, proliferate, differentiate and fuse to form new myofibers. While SCs are indispensable for regeneration, there is increasing evidence for the need for an adequate cellular environment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Artery Disease, Muscle Disorder
What is being tested?
Gastrocnemius muscle biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
30 Apr 2019to 1 Oct 2021
Phase
Interventional
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non PAD patients undergoing vascular surgery for non-occlusive lesions or undergoing orthopedic surgery with gastrocnemius muscle exposure
  • PAD patients > Rutherford Stage 3 or with Chronic Threatening Limb Ischemia, undergoing vascular surgery with gastrocnemius muscle exposure
  • Patients presenting acute limb ischemia and undergoing vascular surgery with gastrocnemius muscle exposure

Who cannot join

  • Major Limb edema
  • Muscle necrosis
  • Acute on chronic ischemia
  • Auto-immune vasculitis

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital Henri Mondor, service de chirurgie vasculaire, 51 avenue Maréchal de Lattre de Tassigny, 94010 Créteil

    Paris, 94010

Other trials in France

About this study

Official title: In Vivo Analysis of Muscle Stem Cell Vascular Niche in Patients Presenting Chronic and Acute Lower Limb Ischemia (MyostemIschemia)

Skeletal muscle regenerates after injury, due to the satellite cells (SCs), the muscle stem cells that activate, proliferate, differentiate and fuse to form new myofibers. While SCs are indispensable for regeneration, there is increasing evidence for the need for an adequate cellular environment. Among the closest cellular partners of SCs are vascular cells. During muscle regeneration, endothelial cells (ECs) stimulate SC differentiation while SCs exhibit pro-angiogenic properties indicating a coupling between angiogenesis and myogenesis.The specific signaling cues controlling these relationships are still poorly characterized, specially in specific pathologic context such as limb ischemia. The investigators research aims to evaluate the role of chronic and acute lower limb ischemia on the SC status and interaction with ECs in human patients.

Read the detailed description

Post-injury muscle regeneration is a multifaceted process requiring the coordination of myogenesis and angiogenesis. Whether this coordination is altered in pathological context has been poorly investigated, whether the original defect stems from the myogenic cell (degenerative myopathy) or the vessel (chronic limb ischemia).

Chronic limb ischemia in patients with peripheral arterial disease (PAD) causes muscle weakness and decreases exercise tolerance. PAD patients with chronic limb ischemia suffer mainly from intermittent claudication on walking or rest pain in more advanced stage, i.e. in critical limb ischemia . PAD is associated with muscle cell apoptosis and atrophy, fiber type switching (from type I to type II), increased muscle fat content and denervation . The underlying mechanisms are from hemodynamic origin and linked to atherosclerotic obstructions of the major arteries supplying the lower extremities. However, additional mechanisms contribute to the limb manifestations, where a reduction in blood flow alone cannot explain exercise limitation in symptomatic PAD patients. These mechanisms include a cascade of pathological responses during exercise-induced ischemia and reperfusion at rest, endothelial dysfunction, oxidative stress, inflammation, and muscle metabolic abnormalities). Surprisingly, the implication of SCs in the pathophysiology of chronic limb ischemia has been overlooked. One could assume that the regenerative capacity of SCs in advanced PAD is overwhelmed by prolonged ischemia. In this case, a decrease in SC regenerative capacities could participate in the aggravation of muscle atrophy and limb perfusion, considering their known pro-angiogenic properties. Consistently, a preclinical study demonstrated that combined delivery of pro-angiogenic and myogenic factors improves ischemic muscle recovery , while endovascular surgery and administration of angiogenic factors (recombinant proteins or gene therapy) or angiogenic cells (cell therapy) showed limited effects. This indicates that promoting angiogenesis along with myogenesis may be a more suitable therapeutic strategy.

Impaired angiogenesis and/or impaired myogenesis are thus novel players in chronic limb ischemia and could represent potential therapeutic targets to delay or alleviate muscle dysfunction.

For PAD patients, muscle biopsies will take place during femoro-popliteal bypass surgery. Control muscle biopsies will be performed in patients undergoing orthopedic surgery of the lower limb or femora-popliteal bypass for non-ischemic reasons (popliteal aneurysm, popliteal entrapment syndrome) In parallel, human SCs in non-PAD patients with <6h acute limb ischemia (from embolic origin) will be obtained. For the PAD study, patients with autoimmune disease, active cancer, end stage renal disease or tissue necrosis or edema close to the site of biopsy will be excluded from this study.

Three major assessments will be performed:

  1. Topographic study: Number, distribution, and relative proximity of SC, and capillaries, fiber type, based on immunohistochemistry applied to standard thin transverse sections, and to thicker segments of cleared muscle.
  2. Functional study: in vitro and in vivo comparison of myogenic potential of SC between ischemic and control patients, based on SC primary cell culture, and SC-ECs co-culture system. Ultimately, SC transplantation in injured muscle of immunodepressed mice will aim to evaluate myogenic capacities.
  3. Transcriptomic analysis: of SCs and ECs sorted from ischemic muscle from PAD patients, control muscle and patients with acute ischemia.

The investigators goal is to analyze and compare the molecular adaptation of ECs and SCs towards chronic ischemia (in a context of muscle atrophy and weakness) as compared with acute ischemia (in a context of normal muscle function) Particular attention in the analysis will be given to the pathways already involved in myogenesis/angiogenesis coupling during muscle regeneration.

Being tested
Gastrocnemius muscle biopsy
Keywords
Muscle ischemia, Satellite cells, Chronic limb ischemia, Endothelial cells
Medical subject headings
Muscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastrocnemius muscle biopsyProcedure or surgery

    In all groups, a 5 mm large gastrocnemius muscle biopsy will be performed and the samples immediately managed in experimental laboratory.

Study groups in NCT03942445
Study groupRoleWhat they receive
Control patientsExperimentalNot described
Receives: Procedure: Gastrocnemius muscle biopsy
Chronic ischemiaExperimentalNot described
Receives: Procedure: Gastrocnemius muscle biopsy
Acute ischemiaExperimentalNot described
Receives: Procedure: Gastrocnemius muscle biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differential expression of genes involved in myogenesis and angiogenesis

    Transcriptomic study through RNA Seq

    Measured: April 2019 - October 2021

Secondary outcomes (4)
  1. Comparative study of the topography of SC and ECs

    Number of SC, capillaries, distance to each others, fiber type, number and diameter of muscle fibers

    Measured: April 2019 - October 2021

  2. Comparative study of myogenic capacity: In vitro differentiation of SC during primary cell culture

    Number of induced myotubes, shape of myotubes, presence of myonuclei (Score 0: Normal, 1: Dystrophic) during cell culture:

    Measured: April 2019 - October 2021

  3. In vitro comparative study of angiogenic capacity

    Number of induced vessels in a co-culture system (SC/HUVECs)

    Measured: April 2019 - October 2021

  4. Myogenic and Angiogenic capacity of transplanted SC (in mice tibialis anterior)

    Ability to induce muscle regeneration, revascularisation, and SC original pool renewal:

    Measurements performed at day 0, 5, 7, 14, 21 days after SC transplantation and tibias anterior lesion

    • Evolution of the number of SC per 100 myofibers
    • Evolution of the number of capillaries per 100 myofibers
    • Evolution of the myofibers diameter
    • Surface of necrosis

    Measured: April 2019 - October 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start30 Apr 2019
  3. Primary completion1 Apr 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942445
Sponsor's protocol ID
C18-35
Status last verified
Jan 2025
First submitted
29 Apr 2019
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gastrocnemius muscle biopsy in people with Artery Disease and Muscle Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jan 2025. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Differential expression of genes involved in myogenesis and angiogenesis (time frame: April 2019 - October 2021). 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 23 Jan 2025.

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