Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy
SCOPE
2 other identifiers
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
October 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2025
CompletedApril 24, 2026
September 1, 2025
2.7 years
April 26, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Effect of botulinum toxin on the proliferation potential of satellite cells: proliferation capacity
30 days
Effect of botulinum toxin on the proliferation potential of satellite cells: differentiation capacity
30 days
Study Arms (1)
OBPP children
EXPERIMENTALOBPP children operated on to treat shoulder stiffness.
Interventions
Peroperative muscle biopsy will be performed during a planned shoulder surgery (arthrolysis and/or muscle transfer)
Eligibility Criteria
You may qualify if:
- OBPP children with a planned shoulder surgery (arthrolysis and/or muscle transfer).
You may not qualify if:
- other neurological disorders, post-traumatic shoulder stiffness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Montpellier
Montpellier, 34000, France
Related Publications (1)
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.
PMID: 37638360RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marion DELPONT, Dr
University Hospital, Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2022
First Posted
June 3, 2022
Study Start
October 17, 2022
Primary Completion
June 25, 2025
Study Completion
June 25, 2025
Last Updated
April 24, 2026
Record last verified: 2025-09