NCT05967325

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

Status unknown NA Last updated 1 August 2023

What this trial tests

NA trial testing Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels in Safety Issues in 15 participants. Status unknown.

Timeline

15 July 2023

Primary endpoint
15 July 2024

15 July 2025

Quick facts

Lead sponsor	Kunming Tongren Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	15 July 2023
Primary completion	15 July 2024
Estimated completion	15 July 2025
Sites	1 location across China

Drugs / interventions tested

• Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels

Conditions studied

• Safety Issues — all drugs for Safety Issues →

Sponsor

Kunming Tongren Hospital

Who can join

Adults 18 to 60, any sex, with Safety Issues. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Functional biomaterials for modulating the dysfunctional pathological microenvironment of spinal cord injury.
   Ma D, Fu C, Li F, Ruan R, et al · · 2024 · cited 28× · PMID 38883317 · DOI 10.1016/j.bioactmat.2024.04.015
2. Insights into Advances and Applications of Biomaterials for Nerve Tissue Injuries and Neurodegenerative Disorders.
   Pai V, Singh BN, Singh AK. · · 2024 · cited 13× · PMID 39348168 · DOI 10.1002/mabi.202400150
3. Bioresponsive engineered nanoparticles for immunomodulation.
   Hegde M, Mishra A, Banerjee R, Bintee B, et al · · 2025 · cited 4× · PMID 41162977 · DOI 10.1186/s12916-025-04305-6
4. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
5. Drug-delivery strategies using biomaterials in the field of nerve regeneration.
   Xu L, Zhou C, Wang X, Fan C. · · 2026 · cited 2× · PMID 40536924 · DOI 10.4103/nrr.nrr-d-25-00027
6. Extracellular Vesicles as Emerging Therapeutic Strategies in Spinal Cord Injury: Ready to Go.
   Jiang J, Wang Z, Bao Q, Chen S, et al · · 2025 · cited 2× · PMID 40427089 · DOI 10.3390/biomedicines13051262
7. Cell therapy for stroke and spinal cord injury in clinical trials.
   Fan Y, Wong ST, Goh ELK, Chan JKY. · · 2026 · PMID 41641797 · DOI 10.1093/stcltm/szaf082
8. Biomaterials-driven stem cell therapy for tissue repair and functional rehabilitation after ischemic stroke.
   Wang M, Ran Y, Liang J, Li F, et al · · 2025 · PMID 41244328 · DOI 10.1002/btm2.70060