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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026279


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name