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)

Pseudoarthrosis Clinical Trial

— Bonecure  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483364
• Other study ID #: STEMQUIRI/12ES01
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Pseudarthrosis
• Pseudoarthrosis

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.