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

• Status: Completed
• Trial end date: 2019-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banc de Sang i Teixits
• Collaborator: Hospital ASEPEYO Sant Cugat

Criteria

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