UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037388 |
|---|---|
| Receipt number | R000042622 |
| Scientific Title | G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with spinal cord injuries. |
| Date of disclosure of the study information | 2019/07/17 |
| Last modified on | 2020/07/16 12:46:25 |
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Basic information
Public title
G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with spinal cord injuries.
Acronym
CD34+ cell transplantation for spinal cord injuries.
Scientific Title
G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with spinal cord injuries.
Scientific Title:Acronym
CD34+ cell transplantation for spinal cord injuries.
Region
| Japan |
Condition
Condition
Spinal cord injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of safety and efficacy of G-CSF mobilized autologous peripheral blood derived CD34+ cell transplantation in spinal cord injury.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy evaluation of the therapy for 48 weeks
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
| Other |
Interventions/Control_1
Intra-thecal injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Cervical and thoracic spinal cord injury patients with ASIA impairment score A and B
2) Within 4 to 16 weeks after injury
3) Incomplete spinal cord injury detectable with MRI
4) Enable to obtain the written consent
Key exclusion criteria
1) Transection of the spinal cord with the MRI
2) Spinal shock
3) Central spinal cord injury
4) Organ failure more than SOFA scale 3
5) Disturbance of consciousness (Japan Come Scale (JCS) III-200 or III-300)
6) Severe respiratory disorder
7) Hematologic disease (leukemia, myeloproliferative disorders, myelodysplastic syndromes, or sickle cell disease)
8) Autoimmune disorders
9) Liver cirrhosis
10) Interstitial pneumonitis or history
11) Malignancy or history of malignancy most recently
12) Positive for following viral infectious disease, HBV, HCV, HIV, ATL, Parvovirus B19.
13) White blood cell count, under 2,000/micro L or greater than 15,000/micro L
14) Platelet count, under 100,000/micro L
15) Hemoglobin concentration, under 8 g/dL
16) Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT), three times greater than normal value
17) Serum albumin, under 2 g/dL
18) Splenomegaly on computed tomography
19) Allergic reaction or adverse reaction to G-CSF, the other reagents, or apheresis
20) Allergic reaction or adverse reaction to the mouse-derived protein
21) Severe multiple injury or multiple organ failure
22) Hemophilia
23) Uncontrolled ischemic heart disease including receiving a cardiovascular surgery or percutaneous coronary intervention within 12 months; severe spinal and peripheral nerve disease; tetraplegia due to brain disorder (brain injury, cerebral infarction, etc.); renal dysfunction (hemodialysis, etc.); or severe psychiatric disorders
24) Pregnancy
25) Participating in other clinical studies within 6 months
26) Ineligible patients on this clinical study based on other clinical evidence
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | TANAKA |
Organization
Shonan Kamakura General Hospital
Division name
Neurosurgery
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
TEL
0467-46-1717
m_tanaka@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | TANAKA |
Organization
Shonan Kamakura General Hospital
Division name
Neurosurgery
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
TEL
0467-46-1717
Homepage URL
m_tanaka@shonankamakura.or.jp
Sponsor or person
Institute
Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Committee of Shonan Kamakura General Hospital for Regenerative Medicine
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
Tel
0467-46-1717
rm_committee@shonankamakura.or.jp
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
| 2019 | Year | 07 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Please refer to the information in jRCT (jRCTb030190220) on and after February 20, 2020.
Management information
Registered date
| 2019 | Year | 07 | Month | 16 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042622
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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