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)

Phase 2

Completed

• Conditions: Pseudoarthrosis
• Interventions: Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)

• Registration Number: NCT02483364
• Lead Sponsor: Salvat

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Study Start: 2015-11-10
• Primary Completion: 2020-05-18
• Study Completion: 2020-10-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)	HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)

Primary Outcome Measures

Name	Time	Method
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.	Within 6 months after surgery.
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.

Secondary Outcome Measures

Name	Time	Method
Comparative statistical analysis	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.

Trial Locations

Locations (1)

Laboratorios Salvat, S.A.; 🇪🇸 Esplugues de Llobregat, Barcelone, Spain