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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 : Recruiting
First Posted : June 26, 2015
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 2018
Estimated Study Completion Date : December 2019

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.




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.



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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.

Information from the National Library of Medicine

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


Contacts
Contact: Enrique Jiménez, MD +34933946400 ext 470 clinicaltrials@svt.com

Locations
Spain
Laboratorios Salvat, S.A. Recruiting
Esplugues de Llobregat, Barcelone, Spain, 08950
Contact: Enrique Jiménez, MD    +34933946400 ext 470    clinicaltrials@svt.com   
Sponsors and Collaborators
Salvat
Investigators
Study Chair: Enrique Jimenez, MD Laboratorios Salvat

Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT02483364     History of Changes
Other Study ID Numbers: STEMQUIRI/12ES01
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries