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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002993
Receipt No. R000003627
Scientific Title A Phase I/ II Clinical Trial: Autologous CD34+ Cell Transplantation for Bone and Vascular Healing in Patients with Non-Union Fracture
Date of disclosure of the study information 2010/01/08
Last modified on 2013/07/08

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Basic information
Public title A Phase I/ II Clinical Trial: Autologous CD34+ Cell Transplantation for Bone and Vascular Healing in Patients with Non-Union Fracture
Acronym Cellular Therapy for Patients with Non-Union Fracture
Scientific Title A Phase I/ II Clinical Trial: Autologous CD34+ Cell Transplantation for Bone and Vascular Healing in Patients with Non-Union Fracture
Scientific Title:Acronym Cellular Therapy for Patients with Non-Union Fracture
Region
Japan

Condition
Condition Non-Union Fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of autologous CD34+ cell transplantation for bone healing in patients with non-union fracture
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes radiological fracture healing at week 12
Key secondary outcomes 1) clinical fracture healing at weeks 8, 12, 24 and year 1
2) period until clinical fracture healing
3) radiological fracture healing at week 8, 24 and year 1
4) fracture healing score of at weeks 8, 12, 24 and year 1
5) period until radiological fracture healing

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
Maneuver
Interventions/Control_1 Operation for non-union fracture (re-fixation) and transplantation of CD34+ cells with atelocollagen as a scaffold
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) Patients with femoral or tibial fracture
2) Patients with fractures which are not healed 9 months after the first treatment (external or internal fixation)
3) Patients with non-union fractures which belong to the noninfected pseudoarthrosis or septic pseudarthrosis without pus discharge / silent infection type by Muller's classification
4) Patients who can give informed consent themselves in writing
Key exclusion criteria 1) Patients (Pts) with congenital femoral or tibial fracture
2) Pts with multiple pseudoarthrosis
3) Pts with radiation therapy, chemotherapy, steroid therapy or immunosuppressant
4) Pts with limb paralysis due to cerebral infarction or spinal cord injury
5) Pts with a history of severe allergic reactions or side effects to G-CSF, collagen products or apheresis
6) Pts with malignant tumor or with a history of malignant tumor in last 5 years
7) Pts with diabetic proliferating retinopathy
8) Pts with unstable angina
9) Less than 6 months since last episode of myocardial/cerebral infarction
10) Pts with leukemia, myeloproliferative disease, or myelodysplastic syndromes
11) Pts with allergic reaction to atelocollagen
12) Pts or their family currently suffering from or having a history of autoimmune disease
13) Pts with end stage renal disease on maintenance hemodialysis
14) Pts with cirrhosis of the liver
15) Pts currently suffering from or having a history of interstitial pneumonitis
16) Pts with cerebral aneurysm indicative for surgical/endovascular treatment by neurosurgeon
17) Leukocytes less than 4,000/uL or exceeding 10,000/uL
18) Platelets less than 100,000/uL
19) Hemoglobin less than 8g/uL
20) AST exceeding 100 IU/uL or ALT exceeding 100 IU/uL
21) Pts with splenomegaly
22) Pts with severe ulcer/ gangrene in the legs with pseudoarthrosis
23) Pts with an operative treatment for the pseudoarthrosis performed in the last 9 months
24) Pts having a plan of another operative treatment in the period of current clinical research
25) Pts infected with HBV, HCV, HIV or HTLV
26) Pts with infectious diseases accompanied by fever over 38 C
27) Pts with uncontrollable mental diseases
28) Pts participating in other clinical trials
29) Pregnant or nursing patients, those who may be pregnant or plan on becoming pregnant before the end of the study period
30) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryosuke Kuroda, M.D., Ph.D.
Organization Kobe University School of Medicine
Division name Department of Orthopaedeic Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5985
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Kuroda, M.D., Ph.D.
Organization Kobe University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address
TEL 078-382-5985
Homepage URL
Email

Sponsor
Institute Ryosuke Kuroda, M.D., Ph.D.
Institute
Department

Funding Source
Organization Coordination, Support and Training Program for Translational Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Foundation for Biomedical Research and Innovation, Institute of Biomedical Research and Innovation Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 08 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
2009 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 07 Day
Last modified on
2013 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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