UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022814 |
|---|---|
| Receipt number | R000026279 |
| 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. |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2021/10/14 14:28:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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/
fbri-project@umin.ac.jp
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation at Kobe
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026279
