Feasibility Safety and Early Functional Outcomes of Intra operative Bone Marrow Derived Stem Cell (BMSC) Application Versus Conventional Repair Alone in Nerve Transfer Surgery for Traumatic Brachial Plexus Injury A Randomised Double Blind Pilot Trial

Department of burns plastic and reconstructive surgery1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2025年11月20日最近更新: 2025年11月5日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 24
试验地点: 1
主要终点: recruitment rate

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This single center randomized double blind pilot at AIIMS Patna Department of Burns Plastic and Reconstructive Surgery will evaluate feasibility safety and early recovery when autologous bone marrow derived stem cells are injected at the nerve repair site and into the distal nerve during standard nerve transfer procedures for traumatic brachial plexus injury Eligible adults aged eighteen to sixty five within seven months of injury will be randomized one to one to surgery plus stem cells or surgery with sham injection Follow up visits occur at one three six and nine months Primary outcomes include recruitment consent retention adherence stem cell processing time and adverse events Secondary outcomes assess early function using MRC muscle grades shoulder and elbow range of motion DASH questionnaire nerve conduction and MRI

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Double

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•patients diagnosed with Pan or extended traumatic upper upper trunk brachial plexus injury of less than 7 months requiring surgical repair namely oberlins repair Spinal accessory to Supra spinatous nerve transfer repair via anterior of posterior approach Intercostal nerve to median nerve transfer intercostal nerve to musculocutaneous nerve transfer patients consenting to intra operative bone marrow derived stem cell application at the nerve reapir site and distal nerve No history of malignancies or active infection ability to provide written informed consent and comply with follow up assessments.

排除标准

•patients with a history of autoimmune disease or significant immunosuppression presence of systemic conditions affecting nerve reapair outcomes like uncontrolled diabetes and severe vascular disease pregnant of lactating women previous brachial plexus repair surgeries or alternative regenrative therapies for the same injury.