Intravenous infusion of autologous mesenchymal stem cells from bone marrow for spinal cord injury patients:open label clinical trial (exploratory trial)
- Conditions
- Spinal cord injury
- Registration Number
- JPRN-jRCT2091220154
- Lead Sponsor
- Toshihiko Yamashita, MD, PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
[Inclusion criteria at the time of first registration]
1)Spinal cord injury onset within 14 days
2)Main damage site of the spinal cord is cervical spinal cord
3)Partial damage of the spinal cord is recognized by image diagnosis (not a complete separation)
4)Classified under A~C of ASIA impairment scale
5)Age between 20 to 70
6)The written informed consent from subjects and legal representative (legal representative alone if the subject does not have ability to write) is provided.
[Inclusion criteria at the time of second registration]
1)Possible to infuse investigational product within 54 days after onset of spinal cord injury
2)Ready to infuse of investigational product which satisfies specification of acceptance criteria
3)Classified under A~C of ASIA impairment scale
[Exclusion criteria at the time of first registration]
(1) High-dose therapy of methylprednisolone is carried out for acute phase
(2) Severe consciousness disturbance (Japan Coma Scale between 200 and 300)
(3) Severe respiratory disorder
(4) Diagnosed as HBV, CV, HIV, HTLV-1,
syphilis, Human Parvovirus B19 by initial screening
(5) Pancytopenia (WBC <2000/mL, neutrophil <1000/mL, Hb <10.0g/dl, Plt <100000/mL)
(6) Past history of malignancy, cirrhosis, autoimmune disease, severe neuropathy, uncontrollable mental disorder, severe diabetes
(7) Past history of penicillin and streptomycin allergy or other severe allergy (shock, anaphylactoid symptoms etc
(8) Poor general condition due to [Endocrine, nutritional and metabolic diseases, Mental disorders, diseases of nervous system, diseases of circulatory system (Uncontrollable and refractory heart failure, moderate or severe valvular heart disorder, uncontrollable and refractory atrial fibrillation, refractory atrial and ventricular thrombus, history of ischemic heart disease and PCI within the past 12 months, serious arrhythmia), diseases of the respiratory system, diseases of the digestive system, diseases of the musculoskeletal system and connective tissue, diseases of the genitourinary system (dialysis etc), injury, poisoning and certain other consequences of external causes etc]
(9) Severe polyinjury or multiple organ failure
(10) Severe pre-existing spinal cord or spinal column disease (osteoporosis, spinal cord tumor, spinal cord vascular malformation, syringomyelia)
(11) Intracranial lesion (moderate asymptomatic lesion, old infarction, white matter lesion, multiple lesions, microbleeding or multiple hemosiderosis, Cerebrovascular diseases such as Moyamoya disease or high risk AN etc, severe intracerebral hemorrhage etc) including past history of these issues.
(12) 70% or more stenosis or dissecting in the artery causing cerebral infarction even though after revascularization (except complete thrombotic occlusion)
(13) Severe arteriosclerotic change and calcification
(14) Preoperative possible uncontrollable HT under depressor therapy (systolic pressure more than 140mmHg, diastolic pressure more than 90mmHg)
[Exclusion criteria at the time of second registration]
(1) Severe consciousness disturbance (Japan Coma Scale between 200 and 300)
(2) Severe respiratory disorder
(3) Diagnosed as HBV, HCV, HIV, HTLV-1, syphilis, Human Parvovirus B19 by initial screening
(4) Neoplasms (except CR), severe diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, severe mental and behavioural disorders, severe diseases of the nervous system, severe congenital malformations, deformations and chromosomal abnormalities
(5) Penicillin and streptomycin allergy and other severe allergy (shock, anaphylactoid symptoms etc)
(6) Poor general condition
(7) Severe polyinjury or multiple organ failure
(8) Severe spinal cord or spinal column disease (osteoporosis, spinal cord tumor, spinal cord vascular malformation, syringomyelia)
(9) Intracranial lesion (moderate asymptomatic lesion, old infarction, white matter lesion, multiple lesions, microbleeding or multiple hemosiderosis, Cerebrovascular diseases such as Moyamoya disease or AN etc, severe intracerebral hemorrhage etc)
(10) 70% or more of stenosis or dissecting in the artery causing cerebral infarction even though after revascularization (except complete thrombotic occlusion)
(11) Severe arteriosclerotic cha
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of cases that American Spinal Injury Association (ASIA) impairment scale improves one point or more at 220 days after onset of spinal cord injury from 40 days after onset.
- Secondary Outcome Measures
Name Time Method [efficacy]<br>-The proportion of cases that ASIA impairment scale improves two points or more at 220 days after onset of spinal cord injury from 40 days after onset <br>-The value of ASIA impairment scale at 220 days after onset of spinal cord injury <br>-The difference of ISCSCI-92 (each item and total score) between 220 and 40 days after onset of spinal cord injury <br>-The ISCSCI-92 (each item and total score) at 220 days after onset of spinal cord injury <br>-The difference of SCIM-III (total score) between 220 and 40 days after onset of spinal cord injury<br>-The SCIM-III (total score) at 220 days after onset of spinal cord injury <br> [safety]<br>-All adverse events rate during whole study period