Autologous cell therapy of fracture non-union – cell phenotype as a predictor of outcome - Phenotype of autologous cells in non-union fractures (PACINO)
- Conditions
- delayed fracture union (fracture non-union)
- Registration Number
- EUCTR2010-019380-11-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Patients undergoing tibial bone transport of 2cm or more.
Age 18 or over.
Able to provide written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Congenital disorders affecting the tibia.
Extensive previous harvesting of bone graft from the iliac crest.
Current active infection.
Previous bone surgery.
Bone metabolic drugs.
Bone metabolic disease.
Haematalogical malignancy.
Other active malignancy.
Inability to attend or comply with treatment.
Pregnancy.
Bovine or gentamycin allergy.
Patient is positive for HIV-1, HIV-2, Hepatitis B (HBV), Hepatitis C(HCV), Syphilis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Do cultured expanded MSCs stimulate more bone regeneration than unmodified bone marrow?<br><br>;Secondary Objective: Does the degree of bone regeneration correlate with the phenotype of the cultured cells across cases?;Primary end point(s): The bone mineral content (BMC) measured in Hounsfield units
- Secondary Outcome Measures
Name Time Method