pseudarthrosis MedDRA version: 16.1 Level: PT Classification code 10048617 Term: Pseudarthrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: XCEL-MT-OSTEO-ALPHA
Product Code: XCEL-MT-OSTEO-ALPHA
Pharmaceutical Form: Living tissue equivalent
INN or Proposed INN: NA
Sponsors
Banc de Sang i Teixits (BST)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 85 years of age (male and female) 2. Atrophic or hypothrophic metaphyseal?diaphyseal pseudarthrosis of long bones, confirmed radiographically. 3. Informed Consent Form signed 4. 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis. 2. Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac). 3. Significant abnormal laboratory tests that contraindicates patient?s participation in the study. 4. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding 5. Smoker of more than 15 cigarettes a day 6. Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism. 7. Badly managed diabetes mellitus. 8. Patients diagnosed with peripheral arterial disorders 9. Previous therapeutic radiation (5 previus years) of the affected bone. 10. Neoplasia within the previous 5 years, or without remission 11. The patient is legally dependent 12. Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days 13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria 14. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To assess the efficacy of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones through quantifying of the Hounsfield units by TC at month 12 postreatment.; Secondary Objective: -To assess the feasibility and safety of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones -To assess the efficacy of XCEL-MT-OSTEO-ALPHA in the treatment of non-hypertrophic pseudarthrosis of long bones through: a)Characteristics of the callus by TC at month 6 postreatment b)Characteristics of the callus by standard x-ray c)Quality of life by EUROQOL-5D test ;Primary end point(s): -Efficacy assessment by TC: quantifying of the Hounsfield units in both treatment arms;Timepoint(s) of evaluation of this end point: At month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: -1: At each study visit -2: RX at month 1, 2, 3, 4, 5, 6, 9 and 12 -3: EUROQOL: at month 1, 3, 6, 9 and 12 ; Secondary end point(s): - Safety assessment through physical examination, vital signs, laboratory parameters and adverse events. - Efficacy assessment by imaging procedures (TC and x-ray) with pseudarthrosis consolidation assessment in both treatment arms - Clinical assessment through quality of life EUROQOL-5D test, | — |
Countries
Spain
Contacts
Public ContactRuth Coll Bonet, Directora Médica
Banc de Sang i Teixits (BST)
Outcome results
None listed