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.

JRCT ID: jRCT2013210056

Registered date:18/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Traumatic Spinal Cord Injury
• Date of first enrollment: 18/12/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Intravenous infusion of autologous mesenchymal stem cells(0.3~2.0x10^8 cells/product) derived from bone marrow

Outcome(s)

• Primary Outcome: Changes in motor function of ISCSCI-92 from 6 to 8 weeks after injury to 6 months after injury in patients aged 20 to 70 years with traumatic cervical spinal cord injury

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.)

Exclude 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.).
(11) Intracranial lesions (severe asymptomatic lesion, severe old infarction, severe white matter lesion, severe multiple lesions, severe 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 changes and calcification in the blood vessels of head and neck.
(14) Preoperative possible uncontrollable HT under depressor therapy (systolic pressure more than 140mmHg, diastolic pressure more than 90mmHg)
(15) Participation in another clinical trials related to any organ or past history of cellular therapy
(16) Pregnant or possibly pregnant, nursing women or those who plan to be pregnant during the study period or male patients who wish the partner to get pregnant
(17) Other patients judged by investigators holding medical license as inappropriate for this study

Related Information

• Primary Sponsor: Tomii Ryo