Fracture non-union
Conditions
Interventions
G-CSF(5 days),Apheresis,Operation for nonunion,CD34+ cells transplantation
Sponsors
Foundation for Biomedical Research and Innovation at Kobe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The patient with nonunion after tibial shaft or femoral fracture(except intraarticular fracture.) Subject of 15 cases of nonunion tibial shaft along maximum of 10 cases of femoral fracture. 2)The patient with nonunion lasting more than 6 months who received the previous surgery for the fracture or nonunion, or treated under the conservative therapy. 3)Nonunion without infection or with infection under the control. 4)The patient with nonunion scheduled for surgery of autogenous bone grafting. 5)At the time of informed consent, ages ranged from 20 to 70. 6)Written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1)Congenital pseudarthrosis. 2)Multiple non-unions. 3)The patient receiving radiation therapy,chemotherapy,steroids or immunosuppressive agents. 4)Presence of limb paralysis due to neurological disorders such as cerebral infarction or spinal cord injury. 5)The patients with allergy to human serum albumin,hypersensitivity. 6)The patients with allergies to cow-derived protein,hypersensitivity. 7)History of anaphylaxis. 8)History of severe adverse drug reaction to G-CSF agent,collagen agent or apheresis. 9)History of hypersensitivity or drug reaction to mouse-derived proteins,iron or iron dextran. 10)The patient unable to discontinue anti-coagulant and anti-platelet agents during perioperative period. 11)Presenting with malignancy or history of malignancy within recent 5years. 12)Presenting with proliferative diabetic retinopathy. 13)History of unstable angina,myocardial infarction,cerebral infarction,cerebral hemorrhage or TIA within recent 3months. 14)Presenting with myeloproliferative disease or MDS. 15)Presenting with severe liver dysfunction,renal failure,heart disease,lung disease,hematologic disease,or endocrine and metabolic disorders. 16)The Patient with positive intradermal tests for atelocollagen. 17)Patient's or family presenting and/or history of autoimmune diseases such as RA,PsA,SLE,DM,PM,chronic thyroiditis,Graves'disease,polyarteritis scleroderma,ulcerative colitis,Crohn's disease,Sjogren syndrome,Reiter syndrome and MCTD. 18)Presence or history of interstitial pneumonia. 19)WBC count < 4,000/uL or WBC count > 10,000/uL 20)Plt count < 100,000/uL 21)Hb < 8g/dL 22)Presence of pathological splenomegaly identified by the US and CT. 23)The Patient received a surgery on nonunion within recent 6months. 24)The patient scheduled for surgery,except for non-union fracture,during the trial. 25)Positive serologic tests. 26)The patient with pregnancy or breast feeding. 27)The patient with alcohol and drug addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The period of bone union assessed by X-ray examination after the surgery for nonunion. | — |
Countries
Japan
Contacts
Public ContactKyoko Hazama
Foundation for Biomedical Research and Innovation at Kobe Div. of Medical Innovation
Outcome results
None listed