Back to resultsA 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) (Bonecure)
Primary Purpose
Pseudoarthrosis
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
Sponsored by
About this trial
This is an interventional treatment trial for Pseudoarthrosis
Eligibility Criteria
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.
Sites / Locations
- Laboratorios Salvat, S.A.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)
Outcomes
Primary Outcome Measures
Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02483364
Brief Title
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)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2015 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salvat
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudoarthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Cell therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)
Intervention Type
Other
Intervention Name(s)
HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
Intervention Description
A single application in the context of a single surgical intervention.
Primary Outcome Measure Information:
Title
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.
Title
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
Time Frame
Within 6 months after surgery.
Secondary Outcome Measure Information:
Title
Comparative statistical analysis
Description
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.
Time Frame
Up to 24 months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Jimenez, MD
Organizational Affiliation
Laboratorios Salvat
Official's Role
Study Chair
Facility Information:
Facility Name
Laboratorios Salvat, S.A.
City
Esplugues de Llobregat
State/Province
Barcelone
ZIP/Postal Code
08950
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
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)
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