Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors

November 19, 2025 updated by: Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

A Prospective, Single-center, Single-arm Clinical Study Protocol on the Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the treatment of spinal cord injury using autologous concentrated growth factors
Biological: Concentrated Growth Factors (CGF)
Concentrated Growth Factors (CGF) have garnered significant attention owing to their distinct biological properties . CGF is a concentrated autologous platelet-rich fibrin matrix derived from centrifuged venous blood, containing high levels of bioactive growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors play pivotal roles in promoting angiogenesis, modulating inflammatory responses, and stimulating cellular proliferation and differentiation. Evidence suggests that CGF not only enhances the local microenvironment at the site of injury but also promotes neural repair by activating endogenous neural stem cells and supporting axonal regeneration, thereby offering a promising multi-target therapeutic approach for spinal cord injury recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ASIA motor score
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACGF-SCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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