Treatment for spinal cord injury patients with bone-marrow cells

JRCT ID: jRCTb051200014

Registered date:15/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Spinal cord injury
• Date of first enrollment: 28/11/2016
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): collection and transplantation of bone marrow cells

Outcome(s)

Primary Outcome

Amount of change between ASIA scores at the registration and that in 6 months later
Improvement: Patient whose ASIA score decreases more than one

Secondary Outcome

(1) Amount of change between motor scores of neurological classification at the registration and that in 6 months later
(2) Amount of change between sensory scores of neurological classification at the registration and that in 6 months later
(3) All of the adverse events from the treatment to 6 months later

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Both

Include criteria

(1)Patients with spinal cord injuries classified as A or B on the ASIA impairment scale
(2)Patients within 12 weeks after injury
(3)Patients with partial spinal cord injury demonstrated by diagnostic imaging
(4)Patients aged between 20 and 60 years at the acquisition of informed consent
(5)Patients who submitted written informed consent by themselves

Exclude criteria

(1)Patients with a completely transected spinal cord
(2)Patients with spinal shock
(3)Patients with central spinal cord injury
(4)Patients with organ failure with a SOFA score of 3 ponts or higher
(5)Patients in whom hepatitis B,hepatitis C,human immunodeficiency virus infection adult T-cell leukemia, or parvovirus B19 infection could not be ruled out
(6)Patients with malignant tumor or a history of malignant tumor within 5 years
(7)Patients with one of the following diseases/disorders
Myeloproliferative disorder or myelodysplastic syndrome
Poorly controlled Ischemic heart disease
Autoimmune disease
Spinal stenosis
Limb paralysis due to central nervous system disorder not attributed to spinal
Liver dysfunction (SOFA score of 3 ponts or higher)
Renal dysfunction (SOFA score of 3 ponts or higher)
Poorly controlled psychiatric disorder
(8)Patients who were participating in other clinical trials or who completed participation within 6 months
(9)Patients who were pregnant or possibly pregnant
(10)Other patients who were judged to be ineligible by the investigators

Related Information

• Primary Sponsor: SUZUKI Yoshihisa