Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones

This is an interventional treatment trial for Atrophic Nonunion of Fracture focused on measuring Nonunion fracture, Long bones, Pseudoarthrosis, Cell therapy, Tissue engineering, Mesenchymal stromal cells Read More

Inclusion Criteria:

• 18 to 85 years of age (male and female)
• Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically.
• Signed Informed Consent Form
• The patient is able to understand the nature of the study

Exclusion Criteria:

• Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
• Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
• Significant abnormal laboratory tests that contraindicates patient's participation in the study.
• Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
• Smoker of more than 15 cigarettes a day
• Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
• Badly managed diabetes mellitus.
• Patients diagnosed with peripheral arterial disorders
• Previous therapeutic radiation (5 previous years) of the affected bone.
• Neoplasia within the previous 5 years, or without remission
• The patient is legally dependent
• Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
• The patient does not accept to be followed-up for a period that could exceed the clinical trial length