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Completed

NCT Number: NCT02483364

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)

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.

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Key information

Conditions

Pseudoarthrosis Fractures, Bone Fractures, Ununited Pseudarthrosis Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Laboratorios Salvat, S.A.

Esplugues de Llobregat, Barcelone, 08950, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of either sex between 18 and 65 years of age (both inclusive).
  • Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.

Exclusion criteria

  • Present infection (infection signs should not be evidenced).
  • Other lesions which interfere with the body weight load.
  • Open pseudoarthrosis (at the time of inclusion).
  • Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
  • Other conditions or circumstances that compromise the study participation according to medical criteria.

Treatment and study plan

HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)

Other

A single application in the context of a single surgical intervention.

Primary outcomes

  1. Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.

    Time frame: Up to 24 months after surgery.

  2. Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.

    Time frame: Within 6 months after surgery.

Secondary outcomes

  1. Comparative statistical analysis

    Time frame: Up to 24 months after surgery.

    Comparative statistical analysis between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since Sept-2009 with 40x10(6) autologous fat stem adult mesenchymal and under AEMPS compassionate use requirements.

Sponsors and collaborators

Lead sponsor

Salvat

Industry

Registry information

Official study title

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

Acronym: Bonecure

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2015
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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