Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up

Stem Cell Research & Therapy
Juan F BlancoFermín Sánchez-Guijo

Abstract

Posterolateral spinal fusion with autologous bone graft is considered the "gold standard" for lumbar degenerative disc disease (DDD) when surgical treatment is indicated. The potential role of mesenchymal stromal cells (MSCs) to replace the bone graft in this setting has not been fully addressed. To analyze the safety, feasibility and potential clinical efficacy of the implantation of autologous MSCs embedded with tricalcium phosphate as a therapeutic alternative to bone graft in patients with DDD during posterolateral spine fusion. Phase I/II single-arm prospective clinical trial. Eleven patients with monosegmental DDD at L4-L5 or L5-S1 level were included. Autologous bone marrow-derived MSC were expanded in our Good Manufacturing Practice (GMP) Facility and implanted during spinal surgery embedded in a tricalcium phosphate carrier. Monitoring of patients included a postoperative period of 12 months with four visits (after the 1st, 3rd, 6th, and 12th month), with clinical and radiological assessment that included the visual analog scale (VAS), the Oswestry disability index (ODI), the Short-Form Health Survey (SF-36), the vertebral fusion grade observed through a simple Rx, and the evaluation of possible complications or advers...Continue Reading

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Citations

Sep 20, 2020·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Bin MengJinxi Wang
Feb 23, 2020·Cartilage·Stephen M EisensteinSally Roberts
Feb 3, 2021·Nature Reviews. Rheumatology·Abbie L A BinchFrank Barry
May 3, 2020·Current Stem Cell Research & Therapy·Saeideh Gholamzadeh KhoeiMohsen Sheykhhasan
Jun 16, 2021·Operative Neurosurgery·Joshua L GolubovskyMichael P Steinmetz
Oct 28, 2021·Expert Reviews in Molecular Medicine·Martin Philipp DieterlePascal Tomakidi

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Methods Mentioned

BETA
density-gradient centrifugation
X-ray

Clinical Trials Mentioned

NCT01513694

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