Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy (SCOPE)

Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy Satellite Cell Obstetrical PlExus (SCOPE)

The purpose of this prospective work is to study the consequences of obstetrical brachial plexus paralysis on the rotator muscles of the shoulder. The hypothesis is that shoulder stiffness of these children is due to an impairment of the shoulder rotator muscles. The investigators want to test the regenerative capacities of these muscles. The development of a cellular model of this pathology will allow to test new therapeutic perspectives and to validate our hypothesis.

Study Overview

• Status: Completed
• Conditions: Obstetrical Brachial Plexus Palsy
• Intervention / Treatment: Procedure: Muscle biopsy

Detailed Description

During delivery, there can be a lesion of the nerve roots of the brachial plexus (cervical C5-C8 and/or thoracic T1 roots). The newborn presents at birth a paralysis of the arm (Obstetrical Brachial Plexus Paralysis: OBPP). One third of children with OBPP will have sequelae despite daily rehabilitation. The most frequent disability is shoulder stiffness. The current hypothesis is that this stiffness is due to a permanent imbalance between the affected shoulder muscles (lateral rotators) and the muscles less affected by the paralysis (medial rotators). Because of this imbalance, the injured shoulder is spontaneously positioned in medial rotation. This position would lead to retractions at the front of the joint despite rehabilitation. In case of incomplete recovery, growth disorders of the shoulder joint (dysplasia) appear as well as a functional handicap.

The management, from the age of 2 years, in case of shoulder stiffness and dysplasia, is surgery (arthrolysis) to regain mobility. During this operation, a muscle transfer can also be performed to strengthen the lateral rotator muscles.

However, despite surgery, mobility deficits often recur within a few years. To understand the origin of the lateral and medial rotation deficits, the investigators conducted an anatomopathological study of the rotator muscles in these children. The preliminary results show a significant damage of the rotator muscles with the presence of fibrosis which could explain the rotational stiffness and the functional impairment. To better understand the pathophysiological mechanisms, the investigatorswill set up an OBPP model in cell culture to understand the regenerative capacities and to test new pharmacological approaches.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• OBPP children with a planned shoulder surgery (arthrolysis and/or muscle transfer).

Exclusion Criteria:

• other neurological disorders, post-traumatic shoulder stiffness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OBPP children; OBPP children operated on to treat shoulder stiffness.	Procedure: Muscle biopsy; Peroperative muscle biopsy will be performed during a planned shoulder surgery (arthrolysis and/or muscle transfer); Other Names: Shoulder arthrolysis; Shoulder muscle transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of muscle regeneration capacity: proliferation capacity	Proliferation capacity of satellite cells assessed by immunofluorescence: percentage of Pax 7 positive cells/total desmin positive cells	30 days
assessment of muscle regeneration capacity: differenciation capacity	Differentiation capacity of satellite cells assessed by histology: fusion index (number of nuclei in a myotubule compared to total number of nuclei in the sample) in percentage	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of botulinum toxin on the proliferation potential of satellite cells: proliferation capacity	Proliferation capacity of satellite cells assessed by immunofluorescence: percentage of Pax 7 positive cells/total desmin positive cells.	30 days
Effect of botulinum toxin on the proliferation potential of satellite cells: differentiation capacity	Differentiation capacity of satellite cells assessed by histology: fusion index (number of nuclei in a myotubule compared to total number of nuclei in the sample) in percentage	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Marion DELPONT, Dr, University Hospital, Montpellier

Publications and helpful links

General Publications

• Douillard M, Deheb Z, Bozon A, Raison-Peyron N, Dereure O, Moulis L, Soria A, Du-Thanh A. Over diagnosis of bradykinin angioedema in patients treated with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. World Allergy Organ J. 2023 Aug 19;16(8):100809. doi: 10.1016/j.waojou.2023.100809. eCollection 2023 Aug.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Denervation; Muscle atrophy; Botulinum toxin; Muscle regeneration; Brachial plexus; Neonatal brachial plexus palsy; Satellite cell; Primary human muscle cell culture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Wounds and Injuries; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Infant, Newborn, Diseases; Atrophy; Brachial Plexus Neuropathies; Birth Injuries; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neonatal Brachial Plexus Palsy; Muscular Atrophy
• Other Study ID Numbers: RECHMPL21_0524; 2021-A02669-32 (Other Identifier: number IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No