UMIN-CTR Clinical Trial

Basic information
Public title	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.
Acronym	Investigator-initiated clinical trial: Autologous peripheral blood cell transplantation in patients with Fracture non-union.
Scientific Title	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.
Scientific Title:Acronym	Investigator-initiated clinical trial: Autologous peripheral blood cell transplantation in patients with Fracture non-union.
Region	Japan

Condition
Condition	Fracture non-union
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety and efficacy of autologous peripheral blood-derived CD34+ cells transplantation for bone and vascular regeneration using investigational devices.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The period of bone union assessed by X-ray examination after the surgery for nonunion.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	G-CSF(5 days),Apheresis,Operation for nonunion,CD34+ cells transplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Kuroda
Organization	Kobe University Hospital
Division name	Department of Orthopedic Surgery
Zip code	650-0017
Address	7-5-2,Kusunoki-cho Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5111
Email	kurodar@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kyoko Middle name Last name Hazama
Organization	Foundation for Biomedical Research and Innovation at Kobe
Division name	Div. of Medical Innovation
Zip code	650-0047
Address	1-5-4,Minatojima Minamimachi Chuo-ku,Kobe 650-0047, Japan
TEL	078-303-9093
Homepage URL	http://www.ibri-kobe.org/fracture/
Email	fbri-project@umin.ac.jp

Sponsor
Institute	Foundation for Biomedical Research and Innovation at Kobe
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	irb sentaniryousenta
Address	1-5-4,Minatojima Minamimachi Chuo-ku,Kobe
Tel	078-306-0798
Email	rinri@fbri.org

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸大学医学部附属病院(兵庫県) 岩手医科大学附属病院（岩手県） 香川大学医学部附属病院（香川県） 帝京大学医学部附属病院（東京都） 神戸市立医療センター中央市民病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
Date of IRB	2015 Year 12 Month 04 Day
Anticipated trial start date	2016 Year 06 Month 23 Day
Last follow-up date	2020 Year 12 Month 24 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 03 Month 23 Day
Date analysis concluded	2021 Year 07 Month 09 Day

Other
Other related information

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2021 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026279