跳至主要内容
临床试验/NCT05403034
NCT05403034已完成不适用

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

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年10月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
assessment of muscle regeneration capacity: differenciation capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
2 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • other neurological disorders, post-traumatic shoulder stiffness

研究组 & 干预措施

OBPP children

Experimental

OBPP children operated on to treat shoulder stiffness.

干预措施: Muscle biopsy (Procedure)

结局指标

主要结局

assessment of muscle regeneration capacity: differenciation capacity

时间窗: 30 days

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

Assessment of muscle regeneration capacity: proliferation capacity

时间窗: 30 days

Proliferation capacity of satellite cells assessed by immunofluorescence: percentage of Pax 7 positive cells/total desmin positive cells

次要结局

  • Effect of botulinum toxin on the proliferation potential of satellite cells: differentiation capacity(30 days)
  • Effect of botulinum toxin on the proliferation potential of satellite cells: proliferation capacity(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验