Pseudoarthrosis Clinical Trial
— BonecureOfficial 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
Verified date | March 2021 |
Source | Salvat |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 20, 2020 |
Est. primary completion date | May 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Laboratorios Salvat, S.A. | Esplugues de Llobregat | Barcelone |
Lead Sponsor | Collaborator |
---|---|
Salvat |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. | Up to 24 months after surgery. | ||
Primary | Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation. | Within 6 months after surgery. | ||
Secondary | 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. | Up to 24 months after surgery. |
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