Status:
COMPLETED
Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca
Conditions:
Pseudoarthrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidati...
Detailed Description
An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depe...
Eligibility Criteria
Inclusion
- Pseudarthrosis of tibia established any cause with at least 9 months.
- The pseudarthrosis is not to show signs of healing in the last 3 months.
- The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
- Age between 18 and 75 years.
- Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
- Negative pregnancy test in women of childbearing age.
- Patient sufficient guarantees of adherence to protocol.
- Signature written informed consent before a witness
Exclusion
- Systemic infection.
- Septic pseudoarthrosis.
- Insufficient skin coverage at the site of nonunion.
- Vascular insufficiency in the affected limb.
- Pathological fracture.
- Concomitant psychiatric or neurological disease.
- Concurrent or prior malignancy treated with chemotherapy over a period of less than 1 year.
- Concomitant severe disease not well controlled.
- Inclusion in other clinical trials.
- Inability to understand the informed consent
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01813188
Start Date
April 1 2011
End Date
June 1 2014
Last Update
March 30 2017
Active Locations (1)
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1
Hospital UniversitarioVirgen de la Arrixaca
El Palmar, Murcia, Spain, 30120