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.
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
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:
- 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.
- 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.
- 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.
- Conditions
- Artery Disease, Muscle Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Control patients | Experimental | Not described Receives: Procedure: Gastrocnemius muscle biopsy |
| Chronic ischemia | Experimental | Not described Receives: Procedure: Gastrocnemius muscle biopsy |
| Acute ischemia | Experimental | Not described Receives: Procedure: Gastrocnemius muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of genes involved in myogenesis and angiogenesis
Transcriptomic study through RNA Seq
Measured: April 2019 - October 2021
Secondary outcomes (4)
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
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
In vitro comparative study of angiogenic capacity
Number of induced vessels in a co-culture system (SC/HUVECs)
Measured: April 2019 - October 2021
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.
- First posted8 May 2019
- Study start30 Apr 2019
- Primary completion1 Apr 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joseph Touma, Dr, Principal investigator, Hôpital Henri Mondor, service de chirurgie vasculaire, 51 avenue Maréchal de Lattre de Tassigny, 94010 Créteil
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Analysis of Muscle Stem Cell Vascular Niche in Patients Presenting Chronic and Acute Lower Limb Ischemia (MyostemIschemia)
- ClinicalTrials.gov ID
- NCT03942445
- Acronym / sponsor ID
- C18-35
- Conditions
- Artery Disease, Muscle Disorder
- Keywords
- Muscle ischemia, Satellite cells, Chronic limb ischemia, Endothelial cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 8 May 2019 (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.
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.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control patients | Experimental | Procedure: Gastrocnemius muscle biopsy |
| Chronic ischemia | Experimental | Procedure: Gastrocnemius muscle biopsy |
| Acute ischemia | Experimental | Procedure: Gastrocnemius muscle biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Major Limb edema
- Muscle necrosis
- Acute on chronic ischemia
- Auto-immune vasculitis
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 |
|---|---|---|
| Gastrocnemius muscle biopsyIn all groups, a 5 mm large gastrocnemius muscle biopsy will be performed and the samples immediately managed in experimental laboratory. | Procedure or surgery | Acute ischemia, Chronic ischemia, Control patients |
Primary outcome
Differential expression of genes involved in myogenesis and angiogenesis
Time frame: April 2019 - October 2021
Transcriptomic study through RNA Seq
4 secondary outcomes
Comparative study of the topography of SC and ECs
Time frame: April 2019 - October 2021
Comparative study of myogenic capacity: In vitro differentiation of SC during primary cell culture
Time frame: April 2019 - October 2021
In vitro comparative study of angiogenic capacity
Time frame: April 2019 - October 2021
Myogenic and Angiogenic capacity of transplanted SC (in mice tibialis anterior)
Time frame: April 2019 - October 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Joseph Touma, Dr principal investigator
Hôpital Henri Mondor, service de chirurgie vasculaire, 51 avenue Maréchal de Lattre de Tassigny, 94010 Créteil
1 site in 1 country: see every site and its status.
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.