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SVF Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT05967325
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Hui Zhu, Kunming Tongren Hospital

Study Description
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Brief Summary:

Traumatic spinal cord injury (SCI) is a severe medical problem experienced by people worldwide with high mortality and long term morbidity. Although progress has been made in understanding cellular and molecular mechanisms of SCI, treatment and management protocols aimed at ameliorating neurologic damage in patients remain ineffective. Cells and biomaterials offer new hope for the treatment of SCI.

Up to now, there have been many studies on the treatment of SCI using cells and biomaterials. Stromal Vascular Fraction (SVF) is a heterogeneous mixture of cells obtained from adipose tissue. These cells include adipose-derived stem cells, endothelial cells, endothelial progenitor cells, pericytes, T cells, and other immune cells. SVF has strong self-renewal, proliferation and differentiation potential, it can replace necrotic cells and synthesize a variety of bioactive factors through paracrine and autocrine, activate cell and vascular regeneration pathways. Therefore, SVF shows significant advantages. The sequence of functional self-assembling peptide nanofiber hydrogels (hereinafter referred to as hydrogels) is HGF(RADA)4RIKVAV (H: histidine; G: Glycine; F: phenylalanine; R: arginine; A: Alanine; D: aspartic acid; I: isoleucine; K: Lysine; V: valerine). The hydrogel is based on the short peptide RADA16 ((RADA)4, which is already available in the product PuramatrixTM for clinical hemostasis and cell culture, but the aqueous solution of PuramatrixTM is acidic which harms cells and tissues upon direct contact. While the hydrogels in this study is pH neutral and does not harm cells and tissues. Articles published by the provider demonstrate that hydrogels can support 3D stem cell growth, have good biocompatibility in vivo (animal spinal cord), and promote neural regeneration after SCI. The chemical structure of the hydrogels is simple and clear, and the degradation product is amino acid. Therefore, SVF and the hydrogel from functional self-assembling peptide are combined for SCI repair in the study.


Condition or disease Intervention/treatment Phase
Safety Issues Procedure: Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Stromal Vascular Fraction (SVF) Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury
Actual Study Start Date : July 15, 2023
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : July 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Procedure: Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
    Transplantation of SVF and biomimetic nanohydrogel

Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Kunming Locomotor Scale (KLS) at 12 months [ Time Frame: Day 0, Month 12 ]
    Scale from minimum (1) to maximum (10), higher scales mean a better outcome.


Secondary Outcome Measures :
  1. Change from Baseline Walking Index for Spinal Cord Injury at 12 months [ Time Frame: Day 0, Month 12 ]
    Score from minimum (0) to maximum (20), higher scores mean a better outcome.

  2. Change from Baseline American Spinal Injury Association International Standards for Neurologic Classification of Spinal Cord Injury at 12 months [ Time Frame: Day 0, Month 12 ]

    Motor scores: bilateral upper and lower extremities total: minimum (0) to maximum (100), higher scores mean a better outcome.

    Sensory scores: bilateral light touch total from minimum (0) and maximum (112), bilateral pin prick from minimum (0) and maximum (112), higher scores mean a better outcome.


  3. Change from Baseline Spinal Cord Independence Measure at 12 months [ Time Frame: Day 0, Month 12 ]
    Score from minimum (0) to maximum (100), higher scores mean a better outcome.

  4. Change from Baseline Modified Ashworth Scale (MAS) at 12 months [ Time Frame: Day 0, Month 12 ]
    Scale from minimum (0) to maximum (4), higher scales mean a worse outcome.

  5. Change from Baseline International Index of Erectile Function at 12 months [ Time Frame: Day 0, Month 12 ]
    Male subjects only. Score from minimum (0) to maximum (25), higher scores mean a better outcome.

  6. Change from Baseline Numerical rating scale at 12 months [ Time Frame: Day 0, Month 12 ]
    Scale from minimum (0) to maximum (10), higher scales mean a worse outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adults, 18-60 years of age, with a clinical diagnosis of chronic traumatic SCI (≥ 3 months after SCI)
  2. Neurological examination: ASIA-A
  3. Both the spinal and neurological levels of injury were between T1-T12
  4. Subjects must be able to read, write and complete visual analogue scale
  5. Voluntarily signs and dates an informed Consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.

Exclusion Criteria:

  1. Subjects with osteoporosis or had joint disease
  2. Severe head injury
  3. Severe pressure sore
  4. Sign of kidney, cardiovascular, liver disorders
  5. Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers)
  6. Pregnant women or women at lactation stages
  7. Medically or mentally unstable according to the judgment of the investigator
  8. History of multiple sclerosis or peripheral demyelination
  9. Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05967325


Contacts
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Contact: HUI ZHU (86)13888092115 kmzhuhui@sina.com

Locations
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China, Yunnan
Kunming Tongren Hospital Recruiting
Kunming, Yunnan, China, 650000
Contact: Hui Zhu, MD    (86)13888092115    kmzhuhui@sina.com   
Sponsors and Collaborators
Kunming Tongren Hospital
More Information
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Responsible Party: Hui Zhu, Director, Kunming Tongren Hospital
ClinicalTrials.gov Identifier: NCT05967325    
Other Study ID Numbers: KunmingTH_HZ_003
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries