UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002993 |
|---|---|
| Receipt number | 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 10:18:25 |
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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
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
Sponsor or person
Institute
Ryosuke Kuroda, M.D., Ph.D.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003627
