Double-blind, randomized, controlled study of intravenous administration of human mesenchymal stem cells derived from bone marrow in patients with chronic spinal cord injury (AIS C and D).

JRCT ID: jRCT2013230003

Registered date:28/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Traumatic Spinal Cord Injury
• Date of first enrollment: 01/03/2023
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Intravenous infusion of autologous mesenchymal stem cells derived from bone marrow

Outcome(s)

• Primary Outcome: Changes in motor function of ISNCSCI f rom immediately before the first administration to 180 days after the first administration.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

(1) Patients with spinal cord injury whose main injury site is the cervical spinal cord and has been onset for more than 180 days.
(2) Patients with AIS C~D SCI and ISNCSCI motor score of 80 points or less.
(3) Patients aged between 18 and 70 at the time of informed consent.
(4) Patients who can receive rehabilitation at least 4 units a day.
(5) The written informed consent from subjects or substitute signer 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 substitute signer.)

Exclude criteria

(1) JCS III-200 or III-300
(2) Severe respiratory distress
(3) Diagnosed as HBV, HCV, HIV, HTLV-1, Human parvovirus B19 or syphilis
(4) Patients with a history of COVID-19 within the past 6 months or patients with current sequelae of COVID-19.
(5) Pancytopenia (WBC <2000/uL, Hb <10.0g/dL, Plt <100000/uL)
(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 multiple organ damage or multiple trauma
(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 other clinical trials
(16)Past history of cellular therapy except STR01 or Stemirac
(17)Patients who received Stemirac Injection or STR01 within the past 2 years.
(18)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
(19)Other patients judged by investigators as inappropriate for this study

Related Information

• Primary Sponsor: Tomii Ryo