Status:
COMPLETED
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
Lead Sponsor:
Banc de Sang i Teixits
Collaborating Sponsors:
Hospital ASEPEYO Sant Cugat
Conditions:
Atrophic Nonunion of Fracture
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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-A...
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 stro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02230514
Start Date
November 20 2014
End Date
December 20 2019
Last Update
April 12 2021
Active Locations (1)
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1
Hospital ASEPEYO Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain, 08174