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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) (Bonecure)

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ClinicalTrials.gov Identifier: NCT02483364
Recruitment Status : Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Salvat

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pseudoarthrosis Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cell therapy
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)
 Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483364


Locations
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Spain
Laboratorios Salvat, S.A.
Esplugues de Llobregat, Barcelone, Spain, 08950
Sponsors and Collaborators
Salvat
Investigators
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Study Chair: Enrique Jimenez, MD Laboratorios Salvat
More Information
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Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT02483364    
Other Study ID Numbers: STEMQUIRI/12ES01
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries