Trial reportJournal of translational medicine2024
Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial.
Trial report in Journal of translational medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02483364 (A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001), which is not on this map. Cited by 10 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.
A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001 (Autologous Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) and HC-SVT-1002 (Allogeneic Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
Who cites it
10 citing papers in PubMed.
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Atrophic Long-Bone Non-Union: Current Insights into Pathogenesis and Management-A Narrative Review.Journal of clinical medicine · 2026Review
- Article
- Mesenchymal Stem Cell-Based Therapies: Challenges and Enhancement Strategies.Cell biochemistry and biophysics · 2026Review
- The Osteoimmunologic Basis of Biologic and Bioengineered Scaffolds in Fracture Healing.Bioengineering (Basel, Switzerland) · 2026Review
- The sole use of stem cells in treating fracture nonunion: a scoping review.Archives of orthopaedic and trauma surgery · 2025Article
- Comparative efficacy of non-vascularized and vascularized bone grafts, with emerging insights into bone biomaterial grafts, in scaphoid fracture nonunion treatment: A systematic review and meta-analysis.Journal of orthopaedic translation · 2025Review
- Stem cell therapies in the clinic.Bioengineering & translational medicine · 2025Review
- Bone Defect Treatment in Regenerative Medicine: Exploring Natural and Synthetic Bone Substitutes.International journal of molecular sciences · 2025Review
- Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications.Journal of clinical medicine · 2025Review
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundAutologous bone grafting is the standard treatment for the surgical management of atrophic nonunion of long bones. Other solutions, such as bone marrow mesenchymal stem cells (BM-MSC) combined with phospho-calcium material, have also been used. Here we evaluate the safety and early efficacy of a novel procedure using autologous or allogenic adipose tissue mesenchymal stromal cells (AT-MSC) seeded in a patented tricalcium phosphate-based biomaterial for the treatment of bone regeneration in cases of atrophic nonunion.
methodsThis was a prospective, multicentric, open-label, phase 2 clinical trial of patients with atrophic nonunion of long bones. Biografts of autologous or allogenic AT-MSC combined with a phosphate substrate were manufactured prior to the surgical procedures. The primary efficacy was measured 6 months after surgery, but patients were followed for 12 months after surgery and a further year out of the scope of the study. All adverse events were recorded. This cohort was compared with a historical cohort of 14 cases treated by the same research team with autologous BM-MSC.
resultsA total of 12 patients with atrophic nonunion of long bones were included. The mean (SD) age was 41.2 (12.1) years and 66.7% were men. Bone healing was achieved in 10 of the 12 cases (83%) treated with the AT-MSC biografts, a percentage of healing similar (11 of the 14 cases, 79%) to that achieved in patients treated with autologous BM-MSC. Overall, two adverse events, in the same patient, were considered related to the procedure.
conclusionsThe results of this study suggest that AT-MSC biografts are safe for the treatment of bone regeneration in cases of atrophic nonunion and reach high healing rates.
trial registrationStudy registered with EUDRA-CT (2013-000930-37) and ClinicalTrials.gov (NCT02483364).
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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 Socratic graph.