Level B· Emerging Clinical EvidenceClinical Trial

Safety and Feasibility of Intradiscal Administration of Matrilin-3-Primed Adipose-Derived Mesenchymal Stromal Cell Spheroids for Chronic Discogenic Low Back Pain: Phase 1 Clinical Trial.

Lee DH., Park KS., Shin HE., Kim SB., Choi H., An SB.

Clinical Trial on Back Pain, Disc Degeneration, published in Int J Mol Sci (2023) — summary generated from the PubMed abstract.

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type: Clinical Trial
Journal: Int J Mol Sci (2023)
Country: Switzerland
Reported sample size: —
PMID: 38069151
DOI: 10.3390/ijms242316827

Abstract (original English)

Functionally enhanced mesenchymal stromal cells participate in the repair of intervertebral disc. This study aimed to assess the safety and tolerability of intradiscal administration of matrilin-3-primed adipose-derived stromal cell (ASC) spheroids with hyaluronic acid (HA) in patients with chronic discogenic low back pain (LBP). In this single-arm, open-label phase I clinical trial, eight patients with chronic discogenic LBP were observed over 6 months. Each patient underwent a one-time intradiscal injection of 1 mL of 6.0 × 10 6 cells/disc combined with HA under real-time fluoroscopic guidance. Safety and feasibility were gauged using Visual Analogue Scale (VAS) pain and Oswestry Disability Index (ODI) scores and magnetic resonance imaging. All participants remained in the trial, with no reported adverse events linked to the procedure or stem cells. A successful outcome-marked by a minimum 2-point improvement in the VAS pain score and a 10-point improvement in ODI score from the start were observed in six participants. Although the modified Pfirrmann grade remained consistent across all participants, radiological improvements were evident in four patients. Specifically, two patients exhibited reduced high-intensity zones while another two demonstrated decreased disc protrusion. In conclusion, the intradiscal application of matrilin-3-primed ASC spheroids with HA is a safe and

What this study does not prove

• This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies exist, but sample sizes, methodology, or follow-up remain limited, so conclusions are not firm.

How we grade evidence

HumansMatrilin ProteinsLow Back PainFeasibility StudiesTreatment OutcomeIntervertebral DiscIntervertebral Disc DegenerationObesityMesenchymal Stem Cells

Back & Spine Back Pain Disc Degeneration

View on PubMed DOI

Safety and Feasibility of Intradiscal Administration of Matrilin-3-Primed Adipose-Derived Mesenchymal Stromal Cell Spheroids for Chronic Discogenic Low Back Pain: Phase 1 Clinical Trial.

Abstract (original English)

What this study does not prove

Evidence level

Related research

Comprehensive Evidence-Based Guidelines for Regenerative Therapies in the Management of Chronic Low Back Pain: 2025 Update from the American Society Of Interventional Pain Physicians (ASIPP).

Mesenchymal Stromal Cells for the Treatment of Discogenic Low Back Pain: A Systematic Review of Clinical Studies.

Stem cells and discogenic back pain.

Potential Role for Stem Cell Regenerative Therapy as a Treatment for Degenerative Disc Disease and Low Back Pain: A Systematic Review.

Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

A systematic review of the safety and efficacy of mesenchymal stem cells for disc degeneration: insights and future directions for regenerative therapeutics.