search
Back to results

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

Primary Purpose

Safety Issues

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
Sponsored by
Kunming Tongren Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety Issues

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female adults, 18-60 years of age, with a clinical diagnosis of chronic traumatic SCI (≥ 3 months after SCI) Neurological examination: ASIA-A Both the spinal and neurological levels of injury were between T1-T12 Subjects must be able to read, write and complete visual analogue scale 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: Subjects with osteoporosis or had joint disease Severe head injury Severe pressure sore Sign of kidney, cardiovascular, liver disorders Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers) Pregnant women or women at lactation stages Medically or mentally unstable according to the judgment of the investigator History of multiple sclerosis or peripheral demyelination Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Sites / Locations

  • Kunming Tongren HospitalRecruiting

Outcomes

Primary Outcome Measures

Change from Baseline Kunming Locomotor Scale (KLS) at 12 months
Scale from minimum (1) to maximum (10), higher scales mean a better outcome.

Secondary Outcome Measures

Change from Baseline Walking Index for Spinal Cord Injury at 12 months
Score from minimum (0) to maximum (20), higher scores mean a better outcome.
Change from Baseline American Spinal Injury Association International Standards for Neurologic Classification of Spinal Cord Injury at 12 months
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.
Change from Baseline Spinal Cord Independence Measure at 12 months
Score from minimum (0) to maximum (100), higher scores mean a better outcome.
Change from Baseline Modified Ashworth Scale (MAS) at 12 months
Scale from minimum (0) to maximum (4), higher scales mean a worse outcome.
Change from Baseline International Index of Erectile Function at 12 months
Male subjects only. Score from minimum (0) to maximum (25), higher scores mean a better outcome.
Change from Baseline Numerical rating scale at 12 months
Scale from minimum (0) to maximum (10), higher scales mean a worse outcome.

Full Information

First Posted
July 7, 2023
Last Updated
July 27, 2023
Sponsor
Kunming Tongren Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05967325
Brief Title
SVF Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kunming Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
Intervention Description
Transplantation of SVF and biomimetic nanohydrogel
Primary Outcome Measure Information:
Title
Change from Baseline Kunming Locomotor Scale (KLS) at 12 months
Description
Scale from minimum (1) to maximum (10), higher scales mean a better outcome.
Time Frame
Day 0, Month 12
Secondary Outcome Measure Information:
Title
Change from Baseline Walking Index for Spinal Cord Injury at 12 months
Description
Score from minimum (0) to maximum (20), higher scores mean a better outcome.
Time Frame
Day 0, Month 12
Title
Change from Baseline American Spinal Injury Association International Standards for Neurologic Classification of Spinal Cord Injury at 12 months
Description
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.
Time Frame
Day 0, Month 12
Title
Change from Baseline Spinal Cord Independence Measure at 12 months
Description
Score from minimum (0) to maximum (100), higher scores mean a better outcome.
Time Frame
Day 0, Month 12
Title
Change from Baseline Modified Ashworth Scale (MAS) at 12 months
Description
Scale from minimum (0) to maximum (4), higher scales mean a worse outcome.
Time Frame
Day 0, Month 12
Title
Change from Baseline International Index of Erectile Function at 12 months
Description
Male subjects only. Score from minimum (0) to maximum (25), higher scores mean a better outcome.
Time Frame
Day 0, Month 12
Title
Change from Baseline Numerical rating scale at 12 months
Description
Scale from minimum (0) to maximum (10), higher scales mean a worse outcome.
Time Frame
Day 0, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults, 18-60 years of age, with a clinical diagnosis of chronic traumatic SCI (≥ 3 months after SCI) Neurological examination: ASIA-A Both the spinal and neurological levels of injury were between T1-T12 Subjects must be able to read, write and complete visual analogue scale 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: Subjects with osteoporosis or had joint disease Severe head injury Severe pressure sore Sign of kidney, cardiovascular, liver disorders Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers) Pregnant women or women at lactation stages Medically or mentally unstable according to the judgment of the investigator History of multiple sclerosis or peripheral demyelination Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HUI ZHU
Phone
(86)13888092115
Email
kmzhuhui@sina.com
Facility Information:
Facility Name
Kunming Tongren Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhu, MD
Phone
(86)13888092115
Email
kmzhuhui@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs