Atrophic pseudarthrosis MedDRA version: 21.1 Level: PT Classification code 10048617 Term: Pseudarthrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: HC-SVT-1001
Product Code: HC-SVT-1001
Pharmaceutical Form: Implant in pre-filled syringe
INN or Proposed INN: Not assigned
Current Sponsor code: HC-SVT-1001
Other descriptive name: EXPAN
Sponsors
Laboratorios Salvat, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients of either sex between 18 and 65 years of age (both inclusive) 2.Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically 3.Hematological and biochemical results without significant alterations where a surgery is contraindicated 4.Signed informed consent from the patient 5.The patient is able to understand the nature of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1.Participation in another clinical trial within the 3 months prior to inclusion. 2.Present infection (infection signs that may impact on the evolution of the lesion should not be evidenced) 3.Other lesions which interfere with the body weight load. 4.Known or suspected allergy to Penicillin, Streptomycin, bovine serum and pig products . 5.Open pseudoarthrosis (at the time of inclusion) 6. Pregnant or lactating women 7.Women of childbearing potential not using effective contraception (eg intrauterine device, oral contraceptives, barrier methods of birth control or other deemed appropriate by the investigator) 8. Neoplastic disease 9. Immunosuppressive state 10. Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism. 11. Chronic renal disease. 12.Smoker of more than 15 cigarettes a day. 13. Badly managed diabetes mellitus. 14. Previous therapeutic radiation (5 previous years) of the affected bone. 15. Peripheral arterial disorders. 16. Other conditions or circumstances that compromise the study participation according to medical criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. - To evaluate the effectiveness by appearance of signs of osseous setting formation at least in 2 out of 3 cortical (tibia) or 3 out of 4 cortical (humerus, femur, cubitus, radius) within 6 months after surgery.;Secondary Objective: Conduct a comparative statistical analysis that relates fundamental aspects like incidence of adverse effects, complications, healing time, etc. 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 1-9-2009 with 40x106 autologous fat stem adult mesenchymal cells, expanded following GMP procedures of IBGM Valladolid and under AEMPS compassionate use requirements.;Primary end point(s): To evaluate the effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation within 6 months after surgery.;Timepoint(s) of evaluation of this end point: Radiographic series performed in pre-surgery and surgery visit and follow-up visits (1 month after surgery and at 3, 4 and 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Conduct a comparative statistical analysis that relates fundamental aspects like incidence of adverse effects, complications, healing time, etc. 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 1-9-2009 with 40x106 autologous fat stem adult mesenchymal cells, expanded following GMP procedures of IBGM Valladolid and under AEMPS compassionate use requirements.;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
Laboratorios Salvat, S.A.
Outcome results
None listed