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)
NCT ID: NCT02483364
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2015-11-10
2020-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)
HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention.
Interventions
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HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Salvat
INDUSTRY
Responsible Party
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Principal Investigators
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Enrique Jimenez, MD
Role: STUDY_CHAIR
Laboratorios Salvat
Locations
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Laboratorios Salvat, S.A.
Esplugues de Llobregat, Barcelone, Spain
Countries
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References
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Orozco Delclos L, Soler Rich R, Arriaza Loureda R, Moreno Garcia A, Gomez Barrena E. Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial. J Transl Med. 2024 May 24;22(1):493. doi: 10.1186/s12967-024-05280-x.
Other Identifiers
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STEMQUIRI/12ES01
Identifier Type: -
Identifier Source: org_study_id
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