A Clinical Trial to Assess the Effect of HC-SVT-1001 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
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|ClinicalTrials.gov Identifier: NCT02483364|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pseudoarthrosis||Other: HC-SVT-1001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cell therapy|
|Masking:||None (Open Label)|
|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) 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|
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3.
A single application in the context of a single surgical intervention.
- Safety of HC-SVT-1001 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. [ Time Frame: Up to 24 months after surgery. ]
- Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation. [ Time Frame: Within 6 months after surgery. ]
- Comparative statistical analysis [ Time Frame: Up to 24 months after surgery. ]Comparative statistical analysis between the 10 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.
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
|Contact: Enrique Jiménez, MD||+34933946400 ext email@example.com|
|Laboratorios SALVAT, S.A.||Recruiting|
|Esplugues de Llobregat, Barcelone, Spain, 08950|
|Contact: Enrique Jiménez, MD +34933946400 ext 470 firstname.lastname@example.org|
|Study Chair:||Enrique Jimenez, MD||Laboratorios Salvat|