Investigator-initiated clinical trial: Autologous peripheral blood-derived CD34+ cells transplantation for bone and vascular regeneration using with MB-001 and IK-02 in patients with Fracture non-union.
- Conditions
- Fracture non-union
- Registration Number
- JPRN-UMIN000022814
- Lead Sponsor
- Foundation for Biomedical Research and Innovation at Kobe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The period of bone union assessed by X-ray examination after the surgery for nonunion.
- Secondary Outcome Measures
Name Time Method