Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
NCT ID: NCT02230514
Last Updated: 2021-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2014-11-20
2019-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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XCEL-MT-OSTEO-ALPHA and surgery
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue
XCEL-MT-OSTEO-ALPHA
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery
Surgery
Standard surgery for non-union fractures
Autologous iliac crest and surgery
Standard treatment
autologous iliac crest
Autologous iliac crest in association with surgery
Surgery
Standard surgery for non-union fractures
Interventions
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XCEL-MT-OSTEO-ALPHA
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery
autologous iliac crest
Autologous iliac crest in association with surgery
Surgery
Standard surgery for non-union fractures
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hospital ASEPEYO Sant Cugat
UNKNOWN
Banc de Sang i Teixits
OTHER
Responsible Party
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Principal Investigators
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Fernando Granell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital ASEPEYO Sant Cugat
Locations
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Hospital ASEPEYO Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain
Countries
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Related Links
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Banc de Sang i Teixits (Blood and Tissue Bank of Catalonia)
Hospital ASEPEYO Sant Cugat
Other Identifiers
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2013-005025-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
XCEL-PSART-01
Identifier Type: -
Identifier Source: org_study_id
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