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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02483364
Other study ID # STEMQUIRI/12ES01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 10, 2015
Est. completion date October 20, 2020

Study information

Verified date March 2021
Source Salvat
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 20, 2020
Est. primary completion date May 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention.

Locations

Country Name City State
Spain Laboratorios Salvat, S.A. Esplugues de Llobregat Barcelone

Sponsors (1)

Lead Sponsor Collaborator
Salvat

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. Up to 24 months after surgery.
Primary Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation. Within 6 months after surgery.
Secondary Comparative statistical analysis 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. Up to 24 months after surgery.
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