Pseudoarthrosis
Conditions
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.
Interventions
OTHERHC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention.
Sponsors
Salvat
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cell therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
| Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation. | Within 6 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparative statistical analysis | 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. |
Countries
Spain
Outcome results
None listed