Using fat-derived cells and peptide hydrogels to treat spinal cord injuries
Safety and Feasibility of Stromal Vascular Fraction (SVF) Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury
NA · Kunming Tongren Hospital · NCT05967325
This study is testing a new treatment using fat-derived cells and special gels to see if it can help adults with chronic spinal cord injuries heal better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Kunming Tongren Hospital (industry) |
| Locations | 1 site (Kunming, Yunnan) |
| Trial ID | NCT05967325 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Stromal Vascular Fraction (SVF) combined with functional self-assembling peptide nanofiber hydrogels for treating chronic traumatic spinal cord injuries. The approach aims to harness the regenerative potential of SVF, which contains various cell types that can promote healing and repair in the spinal cord. Participants will be adults aged 18-60 with a specific type of spinal cord injury, and the study will assess the safety and efficacy of this combined treatment method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with chronic traumatic spinal cord injuries diagnosed at least three months prior.
Not a fit: Patients with severe comorbid conditions such as osteoporosis, severe head injuries, or infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and quality of life for patients with chronic spinal cord injuries.
How similar studies have performed: Previous studies have explored the use of SVF and biomaterials in spinal cord injury treatment, showing promising results, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kunming, Yunnan
- Kunming Tongren Hospital — Kunming, Yunnan, China (RECRUITING)
Study contacts
- Study coordinator: HUI ZHU
- Email: kmzhuhui@sina.com
- Phone: (86)13888092115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Safety Issues