Non-Union Fracture
Conditions
Interventions
Operation for non-union fracture (re-fixation) and transplantation of CD34+ cells with atelocollagen as a scaffold
Sponsors
Ryosuke Kuroda, M.D., Ph.D.
Foundation for Biomedical Research and Innovation, Institute of Biomedical Research and Innovation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with femoral or tibial fracture 2) Patients with fractures which are not healed 9 months after the first treatment (external or internal fixation) 3) Patients with non-union fractures which belong to the noninfected pseudoarthrosis or septic pseudarthrosis without pus discharge / silent infection type by Muller's classification 4) Patients who can give informed consent themselves in writing
Exclusion criteria
Exclusion criteria: 1) Patients (Pts) with congenital femoral or tibial fracture 2) Pts with multiple pseudoarthrosis 3) Pts with radiation therapy, chemotherapy, steroid therapy or immunosuppressant 4) Pts with limb paralysis due to cerebral infarction or spinal cord injury 5) Pts with a history of severe allergic reactions or side effects to G-CSF, collagen products or apheresis 6) Pts with malignant tumor or with a history of malignant tumor in last 5 years 7) Pts with diabetic proliferating retinopathy 8) Pts with unstable angina 9) Less than 6 months since last episode of myocardial/cerebral infarction 10) Pts with leukemia, myeloproliferative disease, or myelodysplastic syndromes 11) Pts with allergic reaction to atelocollagen 12) Pts or their family currently suffering from or having a history of autoimmune disease 13) Pts with end stage renal disease on maintenance hemodialysis 14) Pts with cirrhosis of the liver 15) Pts currently suffering from or having a history of interstitial pneumonitis 16) Pts with cerebral aneurysm indicative for surgical/endovascular treatment by neurosurgeon 17) Leukocytes less than 4,000/uL or exceeding 10,000/uL 18) Platelets less than 100,000/uL 19) Hemoglobin less than 8g/uL 20) AST exceeding 100 IU/uL or ALT exceeding 100 IU/uL 21) Pts with splenomegaly 22) Pts with severe ulcer/ gangrene in the legs with pseudoarthrosis 23) Pts with an operative treatment for the pseudoarthrosis performed in the last 9 months 24) Pts having a plan of another operative treatment in the period of current clinical research 25) Pts infected with HBV, HCV, HIV or HTLV 26) Pts with infectious diseases accompanied by fever over 38 C 27) Pts with uncontrollable mental diseases 28) Pts participating in other clinical trials 29) Pregnant or nursing patients, those who may be pregnant or plan on becoming pregnant before the end of the study period 30) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radiological fracture healing at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) clinical fracture healing at weeks 8, 12, 24 and year 1 2) period until clinical fracture healing 3) radiological fracture healing at week 8, 24 and year 1 4) fracture healing score of at weeks 8, 12, 24 and year 1 5) period until radiological fracture healing | — |
Countries
Japan
Contacts
Public ContactRyosuke Kuroda, M.D., Ph.D.
Kobe University School of Medicine Department of Orthopaedic Surgery
Outcome results
None listed