A Prospective, Single-center, Single-arm Clinical Study Protocol on the Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- ASIA motor score
研究概览
简要总结
Spinal cord injury (SCI) is a severe disorder of the central nervous system, and effective clinical management remains a significant global challenge. Current therapeutic approaches can only partially restore neurological function, leaving the majority of individuals with SCI facing profound and lifelong disabilities. The Department of Spine Surgery at the Third Affiliated Hospital of Sun Yat-sen University is conducting a clinical study on the use of autologous concentrated growth factors for the treatment of spinal cord injury, with the aim of developing a novel and effective clinical intervention strategy.
详细描述
Research Objective: To evaluate the clinical efficacy of autologous concentrated growth factors (Concentrated Growth Factors, CGF) in promoting the recovery of motor, sensory, and autonomic functions in individuals with spinal cord injury (SCI), and to investigate the underlying mechanisms through which CGF contributes to functional restoration of the injured spinal cord.
Study Design: A prospective, single-center, single-arm clinical trial. Study Population: Individuals diagnosed with spinal cord injury who meet predefined inclusion criteria.
Intervention: Eligible participants will receive autologous concentrated growth factor biofilm implantation at the site of spinal cord injury, in conjunction with standard rehabilitation therapy. Participants will undergo structured follow-up assessments at 1, 3, and 6 months post-intervention; an additional follow-up at 12 months will be conducted as a long-term observational time point.
Outcome Measures:
Primary Outcome Measure: Change in ASIA motor score from baseline to each follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese citizens, aged 18-60;
- •Spinal cord injury caused by trauma;
- •ASIA spinal cord injury grade C-D; ④ Duration of the disease: Acute, subacute and chronic spinal cord injuries are all acceptable; ⑤ Cooperate to complete the follow-up.
排除标准
- •Severe systemic diseases;
- •Joint contractures;
- •Having hematological diseases, autoimmune diseases and infectious diseases;
- •Prohibited conditions for magnetic resonance imaging and electrophysiological examinations（For example：intracranial metal implants， cardiac stents, spinal stimulators, spinal internal fixators)；
- •Severe anxiety/depression/manic states， or diagnosed with mental illness or epilepsy； ⑥ Spinal cord injury caused by myelitis， multiple sclerosis， or spinal tumors；
- •Complicated with bleeding disorders or coagulation dysfunction；
- •Individuals with osteoporosis and a high risk of pathological fractures； ⑨ Poor compliance， or unable to correctly understand and cooperate to complete follow-up； ⑩ Pregnant or lactating women； ⑪ Those who have received other spinal cord injury intervention treatments such as stem cells or growth factors within the past 3 months.
研究组 & 干预措施
the treatment of spinal cord injury using autologous concentrated growth factors
干预措施: Concentrated Growth Factors (CGF) (Biological)
结局指标
主要结局
ASIA motor score
时间窗: From enrollment to the end of treatment at 12 months
次要结局
未报告次要终点
研究者
Limin Rong
President
Third Affiliated Hospital, Sun Yat-Sen University