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

Obstetrical Brachial Plexus Palsy Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403034
• Other study ID #: RECHMPL21-0524 7931
• Secondary ID: 2021-A02669-32
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: October 17, 2026

Study information

• Verified date: May 2023
• Source: University Hospital, Montpellier
• Contact: Marion DELPONT, Dr
• Phone: +33 467335035
• Email: m-delpont[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: October 17, 2026
• Est. primary completion date: October 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• other neurological disorders, post-traumatic shoulder stiffness

Related Conditions & MeSH terms

• Neonatal Brachial Plexus Palsy
• Obstetrical Brachial Plexus Palsy
• Paralysis

Intervention

Procedure:
• Muscle biopsy
Peroperative muscle biopsy will be performed during a planned shoulder surgery (arthrolysis and/or muscle transfer)

Locations

Country	Name	City	State
France	Chu Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	PhyMedExp Inserm U1046

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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