NCT03942445

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

April 29, 2019

Last Update Submit

January 21, 2025

Conditions

Artery DiseaseMuscle Disorder

Keywords

Muscle ischemiaSatellite cellsChronic limb ischemiaEndothelial cells

Outcome Measures

Primary Outcomes (1)

  • Differential expression of genes involved in myogenesis and angiogenesis

    Transcriptomic study through RNA Seq

    April 2019 - October 2021

Secondary Outcomes (4)

  • Comparative study of the topography of SC and ECs

    April 2019 - October 2021

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

    April 2019 - October 2021

  • In vitro comparative study of angiogenic capacity

    April 2019 - October 2021

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

    April 2019 - October 2021

Study Arms (3)

Control patients

EXPERIMENTAL
Procedure: Gastrocnemius muscle biopsy

Chronic ischemia

EXPERIMENTAL
Procedure: Gastrocnemius muscle biopsy

Acute ischemia

EXPERIMENTAL
Procedure: Gastrocnemius muscle biopsy

Interventions

Gastrocnemius muscle biopsyPROCEDURE

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

Acute ischemiaChronic ischemiaControl patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 94010, France

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Joseph Touma, Dr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All muscle biopsies are immediately labeled and routed to the lab where technicians and assessors are blinded.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 8, 2019

Study Start

April 30, 2019

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)