Spinal Cord InjuryEarly Phase 1NCT07253233
Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors
A Early Phase 1 study testing Concentrated Growth Factors (CGF) in people with Spinal Cord Injury, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Concentrated Growth Factors (CGF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Concentrated Growth Factors (CGF)
- Keywords
- spinal cord injury, growth factors, autologous
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth Factors (CGF)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| the treatment of spinal cord injury using autologous concentrated growth factors | Experimental | Not described Receives: Biological: Concentrated Growth Factors (CGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASIA motor score
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253233
- Sponsor's protocol ID
- ACGF-SCI
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fouad K, Popovich PG, Kopp MA, Schwab JM. The neuroanatomical-functional paradox in spinal cord injury. Nat Rev Neurol. 2021 Jan;17(1):53-62. doi: 10.1038/s41582-020-00436-x. Epub 2020 Dec 11.
PubMed 33311711Yang F, Zhang R, Xu J, Du J, Leng S, Zhang L, Huang D. Comparative Effects of Concentrated Growth Factors on the Biological Characteristics of Periodontal Ligament Cells and Stem Cells from Apical Papilla. J Endod. 2022 Aug;48(8):1029-1037. doi: 10.1016/j.joen.2022.05.001. Epub 2022 May 8.
PubMed 35545146Hu T, Zhang H, Yu W, Yu X, Li Z, He L. The Combination of Concentrated Growth Factor and Adipose-Derived Stem Cell Sheet Repairs Skull Defects in Rats. Tissue Eng Regen Med. 2021 Oct;18(5):905-913. doi: 10.1007/s13770-021-00371-y. Epub 2021 Jul 24.
PubMed 34302696Noh KC, Liu XN, Zhuan Z, Yang CJ, Kim YT, Lee GW, Choi KH, Kim KO. Leukocyte-Poor Platelet-Rich Plasma-Derived Growth Factors Enhance Human Fibroblast Proliferation In Vitro. Clin Orthop Surg. 2018 Jun;10(2):240-247. doi: 10.4055/cios.2018.10.2.240. Epub 2018 May 18.
PubMed 29854349Wang L, Wan M, Li Z, Zhong N, Liang D, Ge L. A comparative study of the effects of concentrated growth factors in two different forms on osteogenesis in vitro. Mol Med Rep. 2019 Aug;20(2):1039-1048. doi: 10.3892/mmr.2019.10313. Epub 2019 May 30.
PubMed 31173196Denapoli PM, Stilhano RS, Ingham SJ, Han SW, Abdalla RJ. Platelet-Rich Plasma in a Murine Model: Leukocytes, Growth Factors, Flt-1, and Muscle Healing. Am J Sports Med. 2016 Aug;44(8):1962-71. doi: 10.1177/0363546516646100. Epub 2016 May 23.
PubMed 27217525Christgau M, Moder D, Hiller KA, Dada A, Schmitz G, Schmalz G. Growth factors and cytokines in autologous platelet concentrate and their correlation to periodontal regeneration outcomes. J Clin Periodontol. 2006 Nov;33(11):837-45. doi: 10.1111/j.1600-051X.2006.00991.x.
PubMed 17018133Schar MO, Diaz-Romero J, Kohl S, Zumstein MA, Nesic D. Platelet-rich concentrates differentially release growth factors and induce cell migration in vitro. Clin Orthop Relat Res. 2015 May;473(5):1635-43. doi: 10.1007/s11999-015-4192-2.
PubMed 25690170Tabatabaei F, Aghamohammadi Z, Tayebi L. In vitro and in vivo effects of concentrated growth factor on cells and tissues. J Biomed Mater Res A. 2020 Jun;108(6):1338-1350. doi: 10.1002/jbm.a.36906. Epub 2020 Feb 28.
PubMed 32090458Courtine G, Sofroniew MV. Spinal cord repair: advances in biology and technology. Nat Med. 2019 Jun;25(6):898-908. doi: 10.1038/s41591-019-0475-6. Epub 2019 Jun 3.
PubMed 31160817Hutson TH, Di Giovanni S. The translational landscape in spinal cord injury: focus on neuroplasticity and regeneration. Nat Rev Neurol. 2019 Dec;15(12):732-745. doi: 10.1038/s41582-019-0280-3. Epub 2019 Nov 14.
PubMed 31728042Lu Y, Shang Z, Zhang W, Hu X, Shen R, Zhang K, Zhang Y, Zhang L, Liu B, Pang M, Rong L. Global, regional, and national burden of spinal cord injury from 1990 to 2021 and projections for 2050: A systematic analysis for the Global Burden of Disease 2021 study. Ageing Res Rev. 2025 Jan;103:102598. doi: 10.1016/j.arr.2024.102598. Epub 2024 Nov 26.
PubMed 39603465Pedro KM, Fehlings MG. Progress and future directions in spinal cord injury trials. Lancet Neurol. 2025 Jan;24(1):3-5. doi: 10.1016/S1474-4422(24)00482-4. No abstract available.
PubMed 39706629
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Clinical Study Protocol on the Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors
- ClinicalTrials.gov ID
- NCT07253233
- Acronym / sponsor ID
- ACGF-SCI
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, growth factors, autologous
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the treatment of spinal cord injury using autologous concentrated growth factors | Experimental | Biological: Concentrated Growth Factors (CGF) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese citizens, aged 18-60;
Key exclusion criteria (7 listed)
- Severe systemic diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | the treatment of spinal cord injury using autologous concentrated growth factors |
Primary outcome
ASIA motor score
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 33311711Fouad K, Popovich PG, Kopp MA, Schwab JM. The neuroanatomical-functional paradox in spinal cord injury. Nat Rev Neurol. 2021 Jan;17(1):53-62. doi: 10.1038/s41582-020-00436-x. Epub 2020 Dec 11.
- Results publication: PubMed 35545146Yang F, Zhang R, Xu J, Du J, Leng S, Zhang L, Huang D. Comparative Effects of Concentrated Growth Factors on the Biological Characteristics of Periodontal Ligament Cells and Stem Cells from Apical Papilla. J Endod. 2022 Aug;48(8):1029-1037. doi: 10.1016/j.joen.2022.05.001. Epub 2022 May 8.
- Results publication: PubMed 34302696Hu T, Zhang H, Yu W, Yu X, Li Z, He L. The Combination of Concentrated Growth Factor and Adipose-Derived Stem Cell Sheet Repairs Skull Defects in Rats. Tissue Eng Regen Med. 2021 Oct;18(5):905-913. doi: 10.1007/s13770-021-00371-y. Epub 2021 Jul 24.
- Results publication: PubMed 29854349Noh KC, Liu XN, Zhuan Z, Yang CJ, Kim YT, Lee GW, Choi KH, Kim KO. Leukocyte-Poor Platelet-Rich Plasma-Derived Growth Factors Enhance Human Fibroblast Proliferation In Vitro. Clin Orthop Surg. 2018 Jun;10(2):240-247. doi: 10.4055/cios.2018.10.2.240. Epub 2018 May 18.
- Results publication: PubMed 31173196Wang L, Wan M, Li Z, Zhong N, Liang D, Ge L. A comparative study of the effects of concentrated growth factors in two different forms on osteogenesis in vitro. Mol Med Rep. 2019 Aug;20(2):1039-1048. doi: 10.3892/mmr.2019.10313. Epub 2019 May 30.
- Results publication: PubMed 27217525Denapoli PM, Stilhano RS, Ingham SJ, Han SW, Abdalla RJ. Platelet-Rich Plasma in a Murine Model: Leukocytes, Growth Factors, Flt-1, and Muscle Healing. Am J Sports Med. 2016 Aug;44(8):1962-71. doi: 10.1177/0363546516646100. Epub 2016 May 23.
- Results publication: PubMed 17018133Christgau M, Moder D, Hiller KA, Dada A, Schmitz G, Schmalz G. Growth factors and cytokines in autologous platelet concentrate and their correlation to periodontal regeneration outcomes. J Clin Periodontol. 2006 Nov;33(11):837-45. doi: 10.1111/j.1600-051X.2006.00991.x.
- Results publication: PubMed 25690170Schar MO, Diaz-Romero J, Kohl S, Zumstein MA, Nesic D. Platelet-rich concentrates differentially release growth factors and induce cell migration in vitro. Clin Orthop Relat Res. 2015 May;473(5):1635-43. doi: 10.1007/s11999-015-4192-2.
- Results publication: PubMed 32090458Tabatabaei F, Aghamohammadi Z, Tayebi L. In vitro and in vivo effects of concentrated growth factor on cells and tissues. J Biomed Mater Res A. 2020 Jun;108(6):1338-1350. doi: 10.1002/jbm.a.36906. Epub 2020 Feb 28.
- Results publication: PubMed 31160817Courtine G, Sofroniew MV. Spinal cord repair: advances in biology and technology. Nat Med. 2019 Jun;25(6):898-908. doi: 10.1038/s41591-019-0475-6. Epub 2019 Jun 3.
- Results publication: PubMed 31728042Hutson TH, Di Giovanni S. The translational landscape in spinal cord injury: focus on neuroplasticity and regeneration. Nat Rev Neurol. 2019 Dec;15(12):732-745. doi: 10.1038/s41582-019-0280-3. Epub 2019 Nov 14.
- Results publication: PubMed 39603465Lu Y, Shang Z, Zhang W, Hu X, Shen R, Zhang K, Zhang Y, Zhang L, Liu B, Pang M, Rong L. Global, regional, and national burden of spinal cord injury from 1990 to 2021 and projections for 2050: A systematic analysis for the Global Burden of Disease 2021 study. Ageing Res Rev. 2025 Jan;103:102598. doi: 10.1016/j.arr.2024.102598. Epub 2024 Nov 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Concentrated Growth Factors (CGF) in people with Spinal Cord Injury, run by Third Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Bin, doctor (8620-85252900, liubin6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASIA motor score (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07253233, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.