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NCT02483364: Bonecure

A Clinical Trial to Assess the Effect of HC-SVT-1001 and HC-SVT-1002 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones (Bonecure)

Completed Phase 2 Last updated 17 March 2021
What this trial tests

Phase 2 trial testing HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) in Pseudoarthrosis in 12 participants. Completed in 20 October 2020.

Timeline
10 November 2015
Primary endpoint
18 May 2020
20 October 2020

Quick facts

Lead sponsorSalvat
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date10 November 2015
Primary completion18 May 2020
Estimated completion20 October 2020
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Salvat — full company profile →

Who can join

Adults 18 to 65, any sex, with Pseudoarthrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.

Publications & conference data

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

  1. Adult Stem Cells for Bone Regeneration and Repair.
    Iaquinta MR, Mazzoni E, Bononi I, Rotondo JC, et al · · 2019 · cited 176× · PMID 31799249 · DOI 10.3389/fcell.2019.00268
  2. Mesenchymal Stromal Cell-Based Bone Regeneration Therapies: From Cell Transplantation and Tissue Engineering to Therapeutic Secretomes and Extracellular Vesicles.
    Marolt Presen D, Traweger A, Gimona M, Redl H. · · 2019 · cited 104× · PMID 31828066 · DOI 10.3389/fbioe.2019.00352
  3. Recent advances of biomaterials in biotherapy.
    Li L, He ZY, Wei XW, Wei YQ. · · 2016 · cited 37× · PMID 27047675 · DOI 10.1093/rb/rbw007
  4. Frontiers in non-union research.
    Gómez-Barrena E, Padilla-Eguiluz NG, Rosset P. · · 2020 · cited 18× · PMID 33204499 · DOI 10.1302/2058-5241.5.190062
  5. 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.
    Orozco Delclós L, Soler Rich R, Arriaza Loureda R, Moreno García A, et al · · 2024 · cited 10× · PMID 38789992 · DOI 10.1186/s12967-024-05280-x
  6. Biomaterials Mimicking Mechanobiology: A Specific Design for a Specific Biological Application.
    Donati L, Valicenti ML, Giannoni S, Morena F, et al · · 2024 · cited 5× · PMID 39408716 · DOI 10.3390/ijms251910386
  7. An overview of stem cells and cell products involved in trauma injury.
    Saeedi P, Nilchiani LS, Zand B, Hajimirghasemi M, et al · · 2025 · cited 1× · PMID 40143930 · DOI 10.1016/j.reth.2025.02.011

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