Trial reportStem cell research & therapy2019
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.
Trial report in Stem cell research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01513694 (Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.), which is not on this map. Cited by 38 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.
Who cites it
38 citing papers in PubMed, 62 citations in OpenAlex.
- Autologous mesenchymal stem cell transplantation for spinal fusion: 10 years follow-up of a phase I/II clinical trial.Stem cell research & therapy · 2023Trial
- Evolving Treatment Options for Spinal Pain: Balancing Innovation and Affordability in Regenerative Medicine.Current pain and headache reports · 2026Review
- Mesenchymal stem cell and exosome-based therapies for degenerative disc disease: from mechanisms to clinical translation.Frontiers in cell and developmental biology · 2026Review
- Mesenchymal stem cells and the central nervous system: historical perspectives and future directions.Frontiers in molecular neuroscience · 2026Review
- Therapeutic Approaches for Enhancing Spinal Fusion in Low Back Pain: A Review With a Focus on the Elderly.JOR spine · 2025Review
- Bioactive Therapies for Degenerative Disc Disease: Current State of the Art and Clinical Applications.World neurosurgery · 2025Review
- Regenerative strategies for intervertebral disc degeneration.Journal of orthopaedic translation · 2025Review
- Bone fusion materials: past, present, and future.Asian spine journal · 2025Article
- Stem cell therapies in the clinic.Bioengineering & translational medicine · 2025Review
- Application of Endogenous Stem Cells in the Repair of Annulus Fibrosus Injury of Intervertebral Discs.Stem cells international · 2025Review
- Targeting ferroptosis to enhance the efficacy of mesenchymal stem cell-based treatments for intervertebral disc degeneration.International journal of biological sciences · 2025Review
- Review
- Orthobiologic Management Options for Degenerative Disc Disease.Bioengineering (Basel, Switzerland) · 2024Review
- Article
- Mesenchymal Stem Cells and Tissue Bioengineering Applications in Sheep as Ideal Model.Stem cells international · 2024Review
- Osteobiologies for Spinal Fusion from Biological Mechanisms to Clinical Applications: A Narrative Review.International journal of molecular sciences · 2023Review
- Article
- Cell-Based Therapies for Degenerative Musculoskeletal Diseases.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Review
- Innovative design of minimal invasive biodegradable poly(glycerol-dodecanoate) nucleus pulposus scaffold with function regeneration.Nature communications · 2023Article
- Evaluation of instrumentation and pedicle screw design for posterior lumbar fixation: A pre-clinicalJOR spine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPosterolateral 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.
objectiveTo 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. STUDY
designPhase I/II single-arm prospective clinical trial.
methodsEleven 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 adverse reactions. In addition, all patients were further followed up to 5 years for outcome.
resultsMedian age of patients included was 44 years (range 30-58 years), and male/female ratio was (6/5) L4-L5 and L5-S1 DDD was present five and six patients, respectively. Autologous MSCs were expanded in all cases. There were no adverse effects related to cell implantation. Regarding efficacy, both VAS and ODI scores improved after surgery. Radiologically, 80% of patients achieved lumbar fusion at the end of the follow-up. No adverse effects related to the procedure were recorded.
conclusionsThe use of autologous MSCs for spine fusion in patients with monosegmental degenerative disc disease is feasible, safe, and potentially effective.
trial registrationno. EudraCT: 2010-018335-17 ; code Identifier: NCT01513694 ( clinicaltrials.gov ).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.