UMIN-CTR Clinical Trial

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
Email	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
Email	m_tanaka@shonankamakura.or.jp

Sponsor
Institute	Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042622