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 |
G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with spinal cord injuries.
CD34+ cell transplantation for spinal cord injuries.
G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with spinal cord injuries.
CD34+ cell transplantation for spinal cord injuries.
Japan |
Spinal cord injury
Neurosurgery |
Others
NO
Verification of safety and efficacy of G-CSF mobilized autologous peripheral blood derived CD34+ cell transplantation in spinal cord injury.
Safety,Efficacy
Safety and efficacy evaluation of the therapy for 48 weeks
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Intra-thecal injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell.
15 | years-old | <= |
70 | years-old | > |
Male and Female
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
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
6
1st name | Masahiko |
Middle name | |
Last name | TANAKA |
Shonan Kamakura General Hospital
Neurosurgery
247-8533
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
0467-46-1717
m_tanaka@shonankamakura.or.jp
1st name | Masahiko |
Middle name | |
Last name | TANAKA |
Shonan Kamakura General Hospital
Neurosurgery
247-8533
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
0467-46-1717
m_tanaka@shonankamakura.or.jp
Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
None
Self funding
Certified Committee of Shonan Kamakura General Hospital for Regenerative Medicine
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
0467-46-1717
rm_committee@shonankamakura.or.jp
NO
2019 | Year | 07 | Month | 17 | Day |
Unpublished
Terminated
2019 | Year | 05 | Month | 17 | Day |
2019 | Year | 02 | Month | 18 | Day |
2019 | Year | 07 | Month | 17 | Day |
2024 | Year | 02 | Month | 17 | Day |
Please refer to the information in jRCT (jRCTb030190220) on and after February 20, 2020.
2019 | Year | 07 | Month | 16 | Day |
2020 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042622
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |