Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT07253233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors
Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Organization:
Study Overview
Official Title:
A Prospective, Single-center, Single-arm Clinical Study Protocol on the Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Secondary Outcome Measures: ASIA sensory scores, International Association for Neurorestoration-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), Spinal Cord Independence Measure-III (SCIM III), 10-meter Walk Test (10MWT), International Standards for Autonomic Function after SCI (ISAFSCI), Hospital Anxiety and Depression Scale (HADS), bladder function assessment (Geffner scale), bowel function assessment (Neurogenic Bowel Dysfunction Score, NBD), muscle tone evaluation (Modified Ashworth Scale), spasticity assessment (Penn Spasm Frequency Scale), somatosensory evoked potentials (SEP), and multimodal magnetic resonance imaging (MRI) of the brain and spinal cord.
Sample Size: This is an exploratory pilot study designed to enroll 10 participants.
Statistical Analysis Plan: The full analysis set (FAS), per-protocol set (PPS), and safety analysis set will be established. Descriptive statistics will include data distribution assessment (normality testing), summary of baseline characteristics, handling of missing data, and dropout analysis. Inferential statistical analyses will include within-group comparisons over time using appropriate longitudinal models, assessment of potential center effects (if applicable), safety profile evaluation, and exploratory logistic regression analyses to identify potential predictors of response.
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.
Secondary Outcome Measures: ASIA sensory scores, International Association for Neurorestoration-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), Spinal Cord Independence Measure-III (SCIM III), 10-meter Walk Test (10MWT), International Standards for Autonomic Function after SCI (ISAFSCI), Hospital Anxiety and Depression Scale (HADS), bladder function assessment (Geffner scale), bowel function assessment (Neurogenic Bowel Dysfunction Score, NBD), muscle tone evaluation (Modified Ashworth Scale), spasticity assessment (Penn Spasm Frequency Scale), somatosensory evoked potentials (SEP), and multimodal magnetic resonance imaging (MRI) of the brain and spinal cord.
Sample Size: This is an exploratory pilot study designed to enroll 10 participants.
Statistical Analysis Plan: The full analysis set (FAS), per-protocol set (PPS), and safety analysis set will be established. Descriptive statistics will include data distribution assessment (normality testing), summary of baseline characteristics, handling of missing data, and dropout analysis. Inferential statistical analyses will include within-group comparisons over time using appropriate longitudinal models, assessment of potential center effects (if applicable), safety profile evaluation, and exploratory logistic regression analyses to identify potential predictors of response.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: