Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones
PhasePhase 1/Phase 2
Lead SponsorBanc de Sang i Teixits
StatusCompleted No Results Posted
Indication/ConditionAtrophic Nonunion of Fracture
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.
A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrophic pseudoarthrosis of long bones.
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery
Autologous iliac crest in association with surgery
Standard surgery for non-union fractures
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