Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors

NCT07253233 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ACGF-SCI
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; growth factors; autologous

Outcome Measures

Primary Outcomes (1)

• ASIA motor score

  From enrollment to the end of treatment at 12 months

Study Arms (1)

the treatment of spinal cord injury using autologous concentrated growth factors

EXPERIMENTAL

Biological: Concentrated Growth Factors (CGF)

Interventions

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.

the treatment of spinal cord injury using autologous concentrated growth factors

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (13)

• 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.

  PMID: 33311711 RESULT

• Yang 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.

  PMID: 35545146 RESULT

• Hu 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.

  PMID: 34302696 RESULT

• Noh 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.

  PMID: 29854349 RESULT

• Wang 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.

  PMID: 31173196 RESULT

• Denapoli 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.

  PMID: 27217525 RESULT

• Christgau 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.

  PMID: 17018133 RESULT

• Schar 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.

  PMID: 25690170 RESULT

• Tabatabaei 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.

  PMID: 32090458 RESULT

• Courtine 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.

  PMID: 31160817 RESULT

• Hutson 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.

  PMID: 31728042 RESULT

• Lu 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.

  PMID: 39603465 RESULT

• Pedro 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.

  PMID: 39706629 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Liu Bin, doctor

CONTACT

8620-85252900; liubin6@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share