JPRN-jRCT2013210056
Recruiting
Phase 2
Clinical trial to verify safety and efficacy of Stemirac that does not meet in-process control specifications and shipping specifications for acute traumatic spinal cord injury patients.
Tomii Ryo0 sites10 target enrollmentDecember 18, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tomii Ryo
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients with AIS A\~D SCI 6\-8 weeks after injury.
- •(2\) The patients who do not meet some in\-process control specifications and shipping specifications, but conform to the standards of the investigational product.
- •(3\) Patients who can receive rehabilitation at least 4 units a day.
- •(4\) The written informed consent from subjects or legal representative is provided. (The written informed consent obtained as much as possible from subjects. If the subject does not have ability to write etc, the written informed consent obtained from legal representative.)
Exclusion Criteria
- •(1\) The patient is not the origin of the product.
- •(2\) The past\-history of hypersensitivity to RPMI1640, Dimethyl sulfoxide, or Dextran 40\.
- •(3\) JCS III\-200 or III\-300
- •(4\) Severe respiratory distress
- •(5\) Diagnosed as HBV, HCV, HIV, HTLV\-1, Human parvovirus B19 or syphilis
- •(6\) Patients with the following complications 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
- •(7\) Past history of penicillin and streptomycin allergies or other severe allergies (shock, anaphylactoid symptoms, etc.)
- •(8\) Poor general condition due to \[endocrine, nutritional and metabolic diseases, mental disorders, diseases of nervous system, diseases of the 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 polytrauma or multiple organ dysfunction
- •(10\) Has severe spinal cord / spinal disease (severe osteoporosis, spinal cord tumor, spinal vascular malformation, severe syringomyelia, etc.).
Outcomes
Primary Outcomes
Not specified
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