EUCTR2013-000930-37-ESActive, not recruitingPhase 1
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
aboratorios Salvat, S.A.0 sites12 target enrollmentStarted: June 10, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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