Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
- Conditions
- Atrophic Nonunion of Fracture
- Interventions
- Registration Number
- NCT02230514
- Lead Sponsor
- Banc de Sang i Teixits
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autologous iliac crest and surgery Surgery Standard treatment XCEL-MT-OSTEO-ALPHA and surgery XCEL-MT-OSTEO-ALPHA "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue XCEL-MT-OSTEO-ALPHA and surgery Surgery "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue Autologous iliac crest and surgery autologous iliac crest Standard treatment
- Primary Outcome Measures
Name Time Method Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures 12 month Hounsfield units quantification by tomography in both treatment arms
- Secondary Outcome Measures
Name Time Method Efficacy assessment by quality of life test 12 month Quality of life will be measured by EUROQOL-5D test
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures 6 month Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms
Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures 12 month Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month.
Trial Locations
- Locations (1)
Hospital ASEPEYO Sant Cugat
🇪🇸Sant Cugat, Barcelona, Spain