EUCTR2013-000930-37-ES
Active, not recruiting
Phase 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 enrollmentJune 10, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atrophic pseudarthrosis
- Sponsor
- aboratorios Salvat, S.A.
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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