Safety IssuesNCT05967325
SVF Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury
A study testing Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels in people with Safety Issues, run by Kunming Tongren Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kunming Tongren Hospital
Kunming, Yunnan, 650000
Hui Zhu, MD, (86)13888092115, kmzhuhui@sina.com
About this study
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
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.
- Conditions
- Safety Issues
- Being tested
- Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogelsProcedure or surgery
Transplantation of SVF and biomimetic nanohydrogel
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Kunming Locomotor Scale (KLS) at 12 months
Scale from minimum (1) to maximum (10), higher scales mean a better outcome.
Measured: Day 0, Month 12
Secondary outcomes (6)
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.
Measured: Day 0, Month 12
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.
Measured: Day 0, Month 12
Change from Baseline Spinal Cord Independence Measure at 12 months
Score from minimum (0) to maximum (100), higher scores mean a better outcome.
Measured: Day 0, Month 12
Change from Baseline Modified Ashworth Scale (MAS) at 12 months
Scale from minimum (0) to maximum (4), higher scales mean a worse outcome.
Measured: Day 0, Month 12
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.
Measured: Day 0, Month 12
Change from Baseline Numerical rating scale at 12 months
Scale from minimum (0) to maximum (10), higher scales mean a worse outcome.
Measured: Day 0, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Jul 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Zhu, Kunming Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967325
- Sponsor's protocol ID
- KunmingTH_HZ_003
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05967325
- Acronym / sponsor ID
- KunmingTH_HZ_003
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kunming Tongren HospitalUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 1 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogelsTransplantation of SVF and biomimetic nanohydrogel | Procedure or surgery | – |
Primary outcome
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.
6 secondary outcomes
Change from Baseline Walking Index for Spinal Cord Injury at 12 months
Time frame: Day 0, Month 12
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
Change from Baseline Spinal Cord Independence Measure at 12 months
Time frame: Day 0, Month 12
Change from Baseline Modified Ashworth Scale (MAS) at 12 months
Time frame: Day 0, Month 12
Change from Baseline International Index of Erectile Function at 12 months
Time frame: Day 0, Month 12
Change from Baseline Numerical rating scale at 12 months
Time frame: Day 0, Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels in people with Safety Issues, run by Kunming Tongren Hospital at 1 site in China.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HUI ZHU ((86)13888092115, kmzhuhui@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Kunming Locomotor Scale (KLS) at 12 months (time frame: Day 0, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.